The DOI matches its Crossref record; 78 of the 80 references it cites were found in a registry or an index; 1 of the 172 sources its claims cite were checked for support.
Barriers for conducting clinical trials in developing countries—A systematic review
Open accessAbstract
BACKGROUND: Clinical trials for identification of efficient and effective new diagnostic and treatment modalities are needed to address disproportionately high burden of communicable (e.g., HIV/AIDS, tuberculosis, and malaria) and non-communicable diseases (e.g., diabetes) in developing countries. However, gross under-representation in global clinical trial platforms contributes to sustained health inequity in these countries. We reviewed the literature on barriers facing clinical researchers in developing countries for conducting clinical trials in their countries. METHODS: Literature indexed in PubMed, Embase, CINAHL and Web of Science, WHO Global Health Library were searched. Grey literature was also searched. Search key words included barriers, challenges, clinical trials and developing countries. Articles within the scope of this review were appraised by two reviewers. RESULTS: Ten studies, which are reported in 15 papers, were included in this review. Following critical review we identified five unifying themes for barriers. Barriers for conducting clinical trials included lack of financial and human capacity, ethical and regulatory system obstacles, lack of research environment, operational barriers and competing demands. CONCLUSION AND RECOMMENDATION: There were substantial barriers at system, organization and individual level. We propose that to address this problem, instituting a system for wider implementation of local investigator-initiated trials is warranted. These trials are more applicable to local populations because they build on local healthcare knowledge. They are more demand-led, influence policy and responsive to a country's needs because they are driven by a local or national agenda.
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TL;DR
This systematic review identifies five unifying barriers to conducting clinical trials in developing countries: lack of financial and human capacity, ethical and regulatory obstacles, lack of research environment, operational barriers, and competing demands. The authors argue that wider implementation of local investigator-initiated trials is warranted to address these system-, organization-, and individual-level barriers.
Key findings
- Ten studies reported in 15 papers were included; 1,915 titles/abstracts were screened and 1,900 were excluded as out of scope.
- Five barrier themes were identified: lack of financial and human capacity; ethical and regulatory system obstacles; lack of research environment; operational barriers; and competing demands.
- Lack of funding was reported across all included articles except two studies conducted in Saudi Arabia; lack of skilled personnel and lack of awareness/motivation were also reported as human-capacity barriers.
- Of four quantitative studies, one was high quality, two medium, and one low; one medium-quality study had a 23% response rate (92/404), and the low-quality study had a 27% response rate.
- The paper states that less than 20% of clinical trials are conducted in developing countries and only 1% of recently discovered drugs target tropical diseases.
Methods
- Systematic review following PRISMA, searching PubMed, Embase, CINAHL, Web of Science, and WHO Global Health Library, plus grey literature sources including ProQuest Dissertations and Theses and Google Scholar.
- Eligibility: empirical, peer-reviewed studies published in English between 1995 and October 2015 that reported barriers/challenges for conducting clinical trials in developing countries; commentaries, editorials, and literature reviews were excluded.
- Two reviewers independently screened, appraised quality using adapted Newcastle-Ottawa criteria for quantitative studies and Kuper criteria for qualitative studies, and synthesized findings using thematic analysis/synthesis.
Limitations
- Stated: most developing countries were hardly represented; barriers may vary by context, so findings may not reflect any specific country; limited articles meant similarities and differences among developing countries were not examined; most included studies were qualitative with small samples and narrow participant diversity; non-English papers were excluded because translation was not feasible.
- Evident: only 10 studies (15 papers) met inclusion criteria, and the authors did not conduct a meta-synthesis because of diverse settings and methodological approaches.
- Evident: quality assessment found one low-quality quantitative study with high risk of selection bias and low response rate, and one qualitative study/proposal did not describe key qualitative aspects such as approach, data collection, analysis, and interpretation.
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Claims the paper makes
71 Not checked yet · 13 Own result · 10 Own method · 10 Own interpretation · 9 No basis given · 1 Supported so far
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Following critical review we identified five unifying themes for barriers. Barriers for conducting clinical trials included lack of financial and human capacity, ethical and regulatory system obstacles, lack of research environment, operational barriers and competing demands.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Abstract > Results
plain- Asserted: passes — The authors put it forward as true.
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None of the sources cited for this claim have been checked yet.
In the paper
“Absence of suitable research infrastructure was stated by many articles [45, 47–50].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Barriers to conducting clinical trials
What the sources say
- Not checked yetcites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source
- Not checked yetcites [47] Ranasinghe I, Rong Y, Du X, et al. System barriers to the evidence-based Care of Acute Coronary Syndrome (ACS) patients in China: a qualitative analysis. Heart, Lung Circ. 2011;20:S217. source
- Not checked yetcites [48] Franzen SR, Chandler C, Enquselassie F, et al. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia. BMJ Open. 2013;3:e003616. source
- Not checked yetcites [49] Franzen SR, Chandler C, Atashili J, Angus B, Lang T. Barriers and enablers of locally led clinical trials in Ethiopia and Cameroon: a prospective, qualitative study. Lancet. 2013;382:14. source
- Not checked yetcites [50] Cardoso A, Breugelmans G, Manville C, Chataway J, Cochrane G, Snodgrass J. Africa mapping: current state of health research on poverty-related and neglected infectious diseases in sub-Saharan Africa.[internet]. 2014 [cited 2015 Jun 28].
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Of the medium quality studies, one had a low response rate (92 out of 404–23%) [51].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Quality of included studies
What the sources say
- Not checked yetcites [51] Gómez HL, Pinto JA, Castañeda C, Vallejos CS. Current barriers for developing clinical research in Latin America: a cross-sectional survey of medical oncologists. Clin Res. 2015;1:22–8.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“Four articles reported that the presence of unskilled authorities in the review process posed a barrier to conducting clinical trials [42, 45, 48, 49].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Barriers to conducting clinical trials
What the sources say
- Not checked yetcites [42] Pai H. Barriers to conducting clinical research in reproductive medicine: India. Fertil Steril. 2011;96:809–10. source
- Not checked yetcites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source
- Not checked yetcites [48] Franzen SR, Chandler C, Enquselassie F, et al. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia. BMJ Open. 2013;3:e003616. source
- Not checked yetcites [49] Franzen SR, Chandler C, Atashili J, Angus B, Lang T. Barriers and enablers of locally led clinical trials in Ethiopia and Cameroon: a prospective, qualitative study. Lancet. 2013;382:14. source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“Limited capacity in terms of funding were reported in all except two [52, 53] studies conducted in Saudi Arabia [52, 53].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Barriers to conducting clinical trials
What the sources say
- Not checked yetcites [52] Sulthan N. Perception of clinical research among clinical investigators in Saudi Arabia. Asian J. Pharm. Clin. Res. 2015;8:243–6.
- Not checked yetcites [53] Al-Dorzi HM, Naidu B, Khokhar S, White D, Arabi YM. Research experience, interest and perceived barriers of clinical staff working at the intensive care department of a tertiary care academic hospital in Saudi Arabia. Middle East J Anesthesiol. 2013;22:301–7.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“The time from initiation of all regulatory procedures to the actual start of the trial was very long.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Barriers to conducting clinical trials
plain- Asserted: passes — The authors put it forward as true.
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- Load-bearing: passes — The paper’s conclusions depend on it.
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None of the sources cited for this claim have been checked yet.
In the paper
“Delays in regulatory and ethical review were mentioned in most articles [40, 42, 45, 46, 48, 49, 52].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Barriers to conducting clinical trials
What the sources say
- Not checked yetcites [40] Seruga B, Sadikov A, Cazap EL, et al. Barriers and challenges to global clinical cancer research. Oncologist. 2014;19:61–7. source
- Not checked yetcites [42] Pai H. Barriers to conducting clinical research in reproductive medicine: India. Fertil Steril. 2011;96:809–10. source
- Not checked yetcites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source
- Not checked yetcites [46] Siegfried N, Volmink J, Dhansay A. Does South Africa need a national clinical trials support unit? SAMJ: S. Afr. Med. J. 2010;100:521–4. source
- Not checked yetcites [48] Franzen SR, Chandler C, Enquselassie F, et al. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia. BMJ Open. 2013;3:e003616. source
- Not checked yetcites [49] Franzen SR, Chandler C, Atashili J, Angus B, Lang T. Barriers and enablers of locally led clinical trials in Ethiopia and Cameroon: a prospective, qualitative study. Lancet. 2013;382:14. source
- Not checked yetcites [52] Sulthan N. Perception of clinical research among clinical investigators in Saudi Arabia. Asian J. Pharm. Clin. Res. 2015;8:243–6.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“Over-complex and unreasonably strict ethical and regulatory systems were also reported in some articles [48, 49, 51].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Barriers to conducting clinical trials
What the sources say
- Not checked yetcites [48] Franzen SR, Chandler C, Enquselassie F, et al. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia. BMJ Open. 2013;3:e003616. source
- Not checked yetcites [49] Franzen SR, Chandler C, Atashili J, Angus B, Lang T. Barriers and enablers of locally led clinical trials in Ethiopia and Cameroon: a prospective, qualitative study. Lancet. 2013;382:14. source
- Not checked yetcites [51] Gómez HL, Pinto JA, Castañeda C, Vallejos CS. Current barriers for developing clinical research in Latin America: a cross-sectional survey of medical oncologists. Clin Res. 2015;1:22–8.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“For the majority of questions, all except one study [41] scored “good” for most criteria.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Quality of included studies
What the sources say
- Not checked yetcites [41] Schlaff WD. Barriers to conducting clinical research in reproductive medicine around the world. Fertil Steril. 2011;96:801. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“Some articles reported difficulty in patient recruitment [40, 44, 47] as a barrier for conducting clinical trials.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Barriers to conducting clinical trials
What the sources say
- Not checked yetcites [40] Seruga B, Sadikov A, Cazap EL, et al. Barriers and challenges to global clinical cancer research. Oncologist. 2014;19:61–7. source
- Not checked yetcites [44] Chen Z-J. Barriers to conducting clinical research in reproductive medicine: China. Fertil Steril. 2011;96:811–2. source
- Not checked yetcites [47] Ranasinghe I, Rong Y, Du X, et al. System barriers to the evidence-based Care of Acute Coronary Syndrome (ACS) patients in China: a qualitative analysis. Heart, Lung Circ. 2011;20:S217. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Two major stakeholder groups were identified from the included studies: researchers and health professionals.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Comparison of barriers by stakeholders
plain- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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In the paper
“One article reported lack of policymakers’ understanding of the importance of research as barrier [50].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Barriers to conducting clinical trials
What the sources say
- Not checked yetcites [50] Cardoso A, Breugelmans G, Manville C, Chataway J, Cochrane G, Snodgrass J. Africa mapping: current state of health research on poverty-related and neglected infectious diseases in sub-Saharan Africa.[internet]. 2014 [cited 2015 Jun 28].
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Most senior staff for conducting clinical trials were clinicians or academic staff whose primary jobs still had to be prioritised.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Barriers to conducting clinical trials
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“The majority of the articles [43, 45, 47, 48, 51, 52] stated that the administrative environment was characterized by lengthy and complex logistic and financial systems that hampered the conduct of clinical trials.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Barriers to conducting clinical trials
What the sources say
- Not checked yetcites [43] Aboulghar M. Barriers to conducting clinical research in reproductive medicine: Egypt. Fertil Steril. 2011;96:805–6. source
- Not checked yetcites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source
- Not checked yetcites [47] Ranasinghe I, Rong Y, Du X, et al. System barriers to the evidence-based Care of Acute Coronary Syndrome (ACS) patients in China: a qualitative analysis. Heart, Lung Circ. 2011;20:S217. source
- Not checked yetcites [48] Franzen SR, Chandler C, Enquselassie F, et al. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia. BMJ Open. 2013;3:e003616. source
- Not checked yetcites [51] Gómez HL, Pinto JA, Castañeda C, Vallejos CS. Current barriers for developing clinical research in Latin America: a cross-sectional survey of medical oncologists. Clin Res. 2015;1:22–8.
- Not checked yetcites [52] Sulthan N. Perception of clinical research among clinical investigators in Saudi Arabia. Asian J. Pharm. Clin. Res. 2015;8:243–6.
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“Many articles reported that lack of time [40, 48, 51, 53] and other competing priorities related to the competing demands of working multiple jobs and their attendant responsibilities [40, 43, 45, 46, 48, 51, 53] was an issue.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Barriers to conducting clinical trials
What the sources say
- Not checked yetcites [40] Seruga B, Sadikov A, Cazap EL, et al. Barriers and challenges to global clinical cancer research. Oncologist. 2014;19:61–7. source
- Not checked yetcites [48] Franzen SR, Chandler C, Enquselassie F, et al. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia. BMJ Open. 2013;3:e003616. source
- Not checked yetcites [51] Gómez HL, Pinto JA, Castañeda C, Vallejos CS. Current barriers for developing clinical research in Latin America: a cross-sectional survey of medical oncologists. Clin Res. 2015;1:22–8.
- Not checked yetcites [53] Al-Dorzi HM, Naidu B, Khokhar S, White D, Arabi YM. Research experience, interest and perceived barriers of clinical staff working at the intensive care department of a tertiary care academic hospital in Saudi Arabia. Middle East J Anesthesiol. 2013;22:301–7.
- Not checked yetcites [43] Aboulghar M. Barriers to conducting clinical research in reproductive medicine: Egypt. Fertil Steril. 2011;96:805–6. source
- Not checked yetcites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source
- Not checked yetcites [46] Siegfried N, Volmink J, Dhansay A. Does South Africa need a national clinical trials support unit? SAMJ: S. Afr. Med. J. 2010;100:521–4. source
plain- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The greatest challenge that faced researchers in developing countries was lack of financial and human capacity.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
plain- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Clinical researchers conducting clinical trials in low resource settings faced a range of substantial barriers at all levels, starting from the system level, to the institute level, to the individual level.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
plain- Asserted: passes — The authors put it forward as true.
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The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Lack of funds was the most commonly cited reason reported in the included studies.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
plain- Asserted: passes — The authors put it forward as true.
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- Rests on an assumption: Scarce resources in developing countries are nearly all spent on program implementation, and allocating funds for research is almost out of the equation in most development plans.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Lack of time was a less important barrier for clinical researchers.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
plain- Asserted: passes — The authors put it forward as true.
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The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Ethical and regulatory system obstacles emerged as the second most important barrier.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
plain- Asserted: passes — The authors put it forward as true.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“For studies that involved health professionals, competing demands (particularly lack of time) appeared to be the second predominant theme.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
hedged- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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- Rests on an assumption: Most clinicians around the world have competing priorities that require them to engage in caring for patients.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Challenges related to patient recruitment were also reported.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
plain- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“However, this review found a considerable variation regarding lack of time as a barrier between these two groups.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
plaincorrelational- Asserted: passes — The authors put it forward as true.
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The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“In general, barriers for conducting clinical trials were similar between health professionals and researchers”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
plain- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Moreover, an inadequate research environment and various operational barriers, including complex and lengthy financial and logistic systems, appeared in many studies.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“There are wide variations within developing countries with respect to barriers in clinical trial initiation and implementation in these regions.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Conclusion
plain- Asserted: passes — The authors put it forward as true.
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- Based: unclear — It is unclear why the paper says it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“Even within the paucity of literature on conducting clinical trials in low resource countries, the literature mostly relates to ethical issues [19, 26–28].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Introduction
What the sources say
- Not checked yetcites [19] Glickman SW, McHutchison JG, Peterson ED, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360:816–23. source
- Not checked yetcites [26] Angell M. The ethics of clinical research in the third world. N Engl J Med. 1997;337:847–8. source
- Not checked yetcites [27] Shapiro HT, Meslin EM. Ethical issues in the design and conduct of clinical trials in developing countries. N Engl J Med. 2001;345:139–42. source
- Not checked yetcites [28] Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis. 2004;189:930–7. source
plain- Asserted: passes — The authors put it forward as true.
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In the paper
“Diseases of relevance to high-income countries are investigated in clinical trials seven to eight times more often than diseases whose burden lies mainly in low-income and middle-income countries [17].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Introduction
What the sources say
- Not checked yetcites [17] Røttingen J-A, Regmi S, Eide M, et al. Mapping of available health research and development data: what's there, what's missing, and what role is there for a global observatory? Lancet. 2013;382:1286–307. source
plaincorrelational- Asserted: passes — The authors put it forward as true.
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In the paper
“These trials are more applicable to local populations because they build on local healthcare knowledge.”
- Also stated in: § Discussion · plain
“These trials are more applicable to local populations because they build on local healthcare knowledge [76].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Abstract > Conclusion and recommendation
What the sources say
- Not checked yetcites [76] Devasenapathy N, Singh K, Prabhakaran D. Conduct of clinical trials in developing countries: a perspective. Curr Opin Cardiol. 2009;24:295–300. source
plaindirect- Asserted: passes — The authors put it forward as true.
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- Also stated in: § Discussion · plain
In the paper
“More than 80% of clinical trials listed on clinicaltrials.gov [18] are conducted in the developed world.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Introduction
What the sources say
- Not checked yetcites [18] US National Institute of Health. clinicaltrials.gov. 2012.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Another study also found that only 10 of 1556 new drugs produced between 1975 and 2004 were targeting diseases specifically prevalent in poor and low-income countries [20].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Introduction
What the sources say
- Not checked yetcites [20] Chirac P, Torreele E. Global framework on essential health R&D. Lancet. 2006;367:1560–1. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“There were substantial barriers at system, organization and individual level.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Abstract > Conclusion and recommendation
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Funding for clinical trials in developing countries comes mostly from Western countries and the pharmaceutical companies based there [62].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [62] Gaillard J. Measuring Research and Development in developing countries main characteristics and implications for the Frascati manual. Sci. Technol. Soc. 2010;15:77–111. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Contrary to existing beliefs and practices, the lack of resources in low- and middle-income countries paradoxically increases the need for reliable healthcare evidence to prioritize the use of these scarce resources [4].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [4] McMichael C, Waters E, Volmink J. Evidence-based public health: what does it offer developing countries? J. public health. 2005;27:215–21. source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“In most low-income countries, research is a luxury because of economic constraints [63].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [63] Harris E. Building scientific capacity in developing countries. EMBO Rep. 2004;5:7–11. source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Moreover, mobility of highly skilled human resources due to the growing internationalization of the labour market is creating a permanent brain drain [62].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [62] Gaillard J. Measuring Research and Development in developing countries main characteristics and implications for the Frascati manual. Sci. Technol. Soc. 2010;15:77–111. source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“the human and other resource capacity of developing countries lags far behind that available in wealthier nations [57].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [57] Lang TA, White NJ, Hien TT, et al. Clinical research in resource-limited settings: enhancing research capacity and working together to make trials less complicated. PLoS Negl Trop Dis. 2010;4:e619. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“However, due to the widely diverse settings as well as variations in methodological approaches across studies (which are important considerations in developing a more generalized model [38, 39]), we did not conduct a meta-synthesis.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Methods > Data extraction and synthesis
What the sources say
- Not checked yetcites [38] Thorne S, Jensen L, Kearney MH, Noblit G, Sandelowski M. Qualitative metasynthesis: reflections on methodological orientation and ideological agenda. Qual Health Res. 2004;14:1342–65. source
- Not checked yetcites [39] Britten N, Campbell R, Pope C, Donovan J, Morgan M, Pill R. Using meta ethnography to synthesise qualitative research: a worked example. J. Health Serv. Res. Policy. 2002;7:209–15. source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Currently, less than 20% of clinical trials are being conducted in developing countries [54]”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [54] Clinicaltrials.gov. US National Institute of Health. 2015. Available at https://clinicaltrials.gov/ct2/search/map . Accessed 15 Nov 2015.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Recruitment of trial participants is easier than in the developed world; large outcome trials that require enrolment of thousands of patients could make huge savings for the sponsor if the trial is conducted outside of developed countries [74].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [74] Malakoff D. Clinical trials and tribulations. Spiraling costs threaten gridlock. Science (New York, NY). 2008;322:210–3. source
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Subject recruitment is responsible for around 23% of total trial costs, and 87% of US trials fail to meet temporal recruitment and enrolment milestones [75].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [75] Bansal N. The opportunities and challenges in conducting clinical trials globally. Clin Res Regul Aff. 2012;29:9–14. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Exploiting the enormous research potential in developing countries has a double contribution as it can address some of the challenges that face the conduct of clinical trials in the developed world.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Rests on an assumption: The availability of large numbers of tertiary qualified workers and the relatively low salary base in developing countries reduces the cost of running clinical trials.
In the paper
“Subject recruitment is responsible for around 23% of total trial costs, and 87% of US trials fail to meet temporal recruitment and enrolment milestones [75].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [75] Bansal N. The opportunities and challenges in conducting clinical trials globally. Clin Res Regul Aff. 2012;29:9–14. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“However, the potential of scaling up clinical research in developing countries is unlikely to be attained without greater involvement of physicians.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: unclear — It is unclear whether it could be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Rests on an assumption: Physicians in the developing world are already overstretched with responsibilities of patient care.
In the paper
“Recruitment of trial participants is easier than in the developed world; large outcome trials that require enrolment of thousands of patients could make huge savings for the sponsor if the trial is conducted outside of developed countries [74].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [74] Malakoff D. Clinical trials and tribulations. Spiraling costs threaten gridlock. Science (New York, NY). 2008;322:210–3. source
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“However, complex and overly strict ethical and regulatory systems could worsen the negative feedback loop between limited research capacity and small numbers of trials conducted.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“They are more demand-led and responsive to a country’s needs because they are driven by a local or national agenda [77].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [77] Costello A, Zumla A. Moving to research partnerships in developing countries. Br Med J. 2000;321:827. source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“To address these problems in the ethics and regulatory approval systems, some capacity strengthening activities have been initiated through grants from the developed world [70].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [70] Mboya-Okeyo T, Ridley RG, Nwaka S. The African network for drugs and diagnostics innovation. Lancet. 2009;373:1507–8. source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Probably not a substantial claim. 37
- It may state two separate claims as one. 43
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“This review is prepared based on the Preferred Reporting Items for Systematic Reviews and Meta- Analyses (PRISMA) statement checklist and flow diagram [30], modified for health service reviews [31].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Methods
What the sources say
- Not checked yetcites [30] Moher D, Liberati A, Tetzlaff J, Altman DG, Group P. Reprint—preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Phys Ther. 2009;89:873–80. source
- Supportedcites [31] Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med. 2009;151:W-65–94. source
The Development of PRISMA section (p. 2) identifies a 27-item checklist and four-phase flow diagram, supporting the citation to those reporting resources. The health-service-review modification is attached to a separate citation, [31], not to this source. (LLM, conf=0.93)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Finally, as the key findings were similar across studies, we chose to present and discuss the unifying themes and include both for the quantitative and qualitative studies in each theme.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Methods > Data extraction and synthesis
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Ten studies, which are reported in 15 papers, were included in this review.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Abstract > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Of the four quantitative studies, one study was high quality, two were medium quality and one was low quality.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Quality of included studies
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“The study considered to be of low quality showed a high risk of selection bias secondary to purposive sampling procedure for participant selection as well as a low response rate (27%). Moreover, a comparison between respondents and non-respondents was not provided as demographic data were obtained only for the respondents [40]”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Quality of included studies
What the sources say
- Not checked yetcites [40] Seruga B, Sadikov A, Cazap EL, et al. Barriers and challenges to global clinical cancer research. Oncologist. 2014;19:61–7. source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Describing the exact period was not common but one study stated that it was not uncommon for grants to expire before all approvals were in place.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Barriers to conducting clinical trials
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“In the other study, sample size was not justified and there is no description of the sampling strategy [52].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Quality of included studies
What the sources say
- Not checked yetcites [52] Sulthan N. Perception of clinical research among clinical investigators in Saudi Arabia. Asian J. Pharm. Clin. Res. 2015;8:243–6.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Financial and human capital barriers were reported across all articles.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Barriers to conducting clinical trials
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“The proposal [41] which led to publication of participants’ views from each represented country [42–45] did not present some important aspects of qualitative studies: the specific qualitative approach was not described and the research report did not describe the process of data collection, analysis and interpretation”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Quality of included studies
What the sources say
- Not checked yetcites [41] Schlaff WD. Barriers to conducting clinical research in reproductive medicine around the world. Fertil Steril. 2011;96:801. source
- Not checked yetcites [42] Pai H. Barriers to conducting clinical research in reproductive medicine: India. Fertil Steril. 2011;96:809–10. source
- Not checked yetcites [43] Aboulghar M. Barriers to conducting clinical research in reproductive medicine: Egypt. Fertil Steril. 2011;96:805–6. source
- Not checked yetcites [44] Chen Z-J. Barriers to conducting clinical research in reproductive medicine: China. Fertil Steril. 2011;96:811–2. source
- Not checked yetcites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Regarding human capacity, both lack of skilled personnel [40, 42, 44, 45, 48–50, 52, 53] and lack of awareness and of motivation to participate [43, 45, 48, 49, 52, 53] were reported as barriers.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Barriers to conducting clinical trials
What the sources say
- Not checked yetcites [40] Seruga B, Sadikov A, Cazap EL, et al. Barriers and challenges to global clinical cancer research. Oncologist. 2014;19:61–7. source
- Not checked yetcites [42] Pai H. Barriers to conducting clinical research in reproductive medicine: India. Fertil Steril. 2011;96:809–10. source
- Not checked yetcites [44] Chen Z-J. Barriers to conducting clinical research in reproductive medicine: China. Fertil Steril. 2011;96:811–2. source
- Not checked yetcites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source
- Not checked yetcites [48] Franzen SR, Chandler C, Enquselassie F, et al. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia. BMJ Open. 2013;3:e003616. source
- Not checked yetcites [49] Franzen SR, Chandler C, Atashili J, Angus B, Lang T. Barriers and enablers of locally led clinical trials in Ethiopia and Cameroon: a prospective, qualitative study. Lancet. 2013;382:14. source
- Not checked yetcites [50] Cardoso A, Breugelmans G, Manville C, Chataway J, Cochrane G, Snodgrass J. Africa mapping: current state of health research on poverty-related and neglected infectious diseases in sub-Saharan Africa.[internet]. 2014 [cited 2015 Jun 28].
- Not checked yetcites [52] Sulthan N. Perception of clinical research among clinical investigators in Saudi Arabia. Asian J. Pharm. Clin. Res. 2015;8:243–6.
- Not checked yetcites [53] Al-Dorzi HM, Naidu B, Khokhar S, White D, Arabi YM. Research experience, interest and perceived barriers of clinical staff working at the intensive care department of a tertiary care academic hospital in Saudi Arabia. Middle East J Anesthesiol. 2013;22:301–7.
- Not checked yetcites [43] Aboulghar M. Barriers to conducting clinical research in reproductive medicine: Egypt. Fertil Steril. 2011;96:805–6. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Four [40, 47, 51, 53] of the ten included studies reported findings from health professionals, the remaining six studies involved health researchers [41–46, 48–50, 52].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Comparison of barriers by stakeholders
What the sources say
- Not checked yetcites [40] Seruga B, Sadikov A, Cazap EL, et al. Barriers and challenges to global clinical cancer research. Oncologist. 2014;19:61–7. source
- Not checked yetcites [47] Ranasinghe I, Rong Y, Du X, et al. System barriers to the evidence-based Care of Acute Coronary Syndrome (ACS) patients in China: a qualitative analysis. Heart, Lung Circ. 2011;20:S217. source
- Not checked yetcites [51] Gómez HL, Pinto JA, Castañeda C, Vallejos CS. Current barriers for developing clinical research in Latin America: a cross-sectional survey of medical oncologists. Clin Res. 2015;1:22–8.
- Not checked yetcites [53] Al-Dorzi HM, Naidu B, Khokhar S, White D, Arabi YM. Research experience, interest and perceived barriers of clinical staff working at the intensive care department of a tertiary care academic hospital in Saudi Arabia. Middle East J Anesthesiol. 2013;22:301–7.
- Not checked yetcites [41] Schlaff WD. Barriers to conducting clinical research in reproductive medicine around the world. Fertil Steril. 2011;96:801. source
- Not checked yetcites [42] Pai H. Barriers to conducting clinical research in reproductive medicine: India. Fertil Steril. 2011;96:809–10. source
- Not checked yetcites [43] Aboulghar M. Barriers to conducting clinical research in reproductive medicine: Egypt. Fertil Steril. 2011;96:805–6. source
- Not checked yetcites [44] Chen Z-J. Barriers to conducting clinical research in reproductive medicine: China. Fertil Steril. 2011;96:811–2. source
- Not checked yetcites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source
- Not checked yetcites [46] Siegfried N, Volmink J, Dhansay A. Does South Africa need a national clinical trials support unit? SAMJ: S. Afr. Med. J. 2010;100:521–4. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“With the exception of concerns around time [40, 48, 51, 53], reported barriers for conducting clinical trials were similar between these two groups, with financial and human barriers being the most common in both groups.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Comparison of barriers by stakeholders
What the sources say
- Not checked yetcites [40] Seruga B, Sadikov A, Cazap EL, et al. Barriers and challenges to global clinical cancer research. Oncologist. 2014;19:61–7. source
- Not checked yetcites [48] Franzen SR, Chandler C, Enquselassie F, et al. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia. BMJ Open. 2013;3:e003616. source
- Not checked yetcites [51] Gómez HL, Pinto JA, Castañeda C, Vallejos CS. Current barriers for developing clinical research in Latin America: a cross-sectional survey of medical oncologists. Clin Res. 2015;1:22–8.
- Not checked yetcites [53] Al-Dorzi HM, Naidu B, Khokhar S, White D, Arabi YM. Research experience, interest and perceived barriers of clinical staff working at the intensive care department of a tertiary care academic hospital in Saudi Arabia. Middle East J Anesthesiol. 2013;22:301–7.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Lack of research materials for conducting clinical trials [40, 46, 47] and lack of conducive scientific atmosphere (including policy) [43, 45, 50] were also reported.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Barriers to conducting clinical trials
What the sources say
- Not checked yetcites [40] Seruga B, Sadikov A, Cazap EL, et al. Barriers and challenges to global clinical cancer research. Oncologist. 2014;19:61–7. source
- Not checked yetcites [46] Siegfried N, Volmink J, Dhansay A. Does South Africa need a national clinical trials support unit? SAMJ: S. Afr. Med. J. 2010;100:521–4. source
- Not checked yetcites [47] Ranasinghe I, Rong Y, Du X, et al. System barriers to the evidence-based Care of Acute Coronary Syndrome (ACS) patients in China: a qualitative analysis. Heart, Lung Circ. 2011;20:S217. source
- Not checked yetcites [43] Aboulghar M. Barriers to conducting clinical research in reproductive medicine: Egypt. Fertil Steril. 2011;96:805–6. source
- Not checked yetcites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source
- Not checked yetcites [50] Cardoso A, Breugelmans G, Manville C, Chataway J, Cochrane G, Snodgrass J. Africa mapping: current state of health research on poverty-related and neglected infectious diseases in sub-Saharan Africa.[internet]. 2014 [cited 2015 Jun 28].
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“There were, however, a considerable variation regarding lack of time as a barrier, with most (3 out of 4) studies that reported views of health professionals [40, 51, 53] putting more emphasis on lack of time and only one study [48] that involved clinical researchers reporting lack of time as a barrier.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Comparison of barriers by stakeholders
What the sources say
- Not checked yetcites [40] Seruga B, Sadikov A, Cazap EL, et al. Barriers and challenges to global clinical cancer research. Oncologist. 2014;19:61–7. source
- Not checked yetcites [51] Gómez HL, Pinto JA, Castañeda C, Vallejos CS. Current barriers for developing clinical research in Latin America: a cross-sectional survey of medical oncologists. Clin Res. 2015;1:22–8.
- Not checked yetcites [53] Al-Dorzi HM, Naidu B, Khokhar S, White D, Arabi YM. Research experience, interest and perceived barriers of clinical staff working at the intensive care department of a tertiary care academic hospital in Saudi Arabia. Middle East J Anesthesiol. 2013;22:301–7.
- Not checked yetcites [48] Franzen SR, Chandler C, Enquselassie F, et al. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia. BMJ Open. 2013;3:e003616. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The Embase search returned the highest number of publications (1076). Web of Science, PubMed, Cinhal and WHO Global Health Library returned 760, 712, 267 and 191 publications respectively.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Regarding health conditions, six (60%) of included studies assessed barriers of conducting clinical trials on non-specific health conditions. The remaining four studies assessed barriers to conducting clinical trials in cancer [40, 51], reproductive disease [41] and acute coronary syndrome [47].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Selected studies
What the sources say
- Not checked yetcites [40] Seruga B, Sadikov A, Cazap EL, et al. Barriers and challenges to global clinical cancer research. Oncologist. 2014;19:61–7. source
- Not checked yetcites [51] Gómez HL, Pinto JA, Castañeda C, Vallejos CS. Current barriers for developing clinical research in Latin America: a cross-sectional survey of medical oncologists. Clin Res. 2015;1:22–8.
- Not checked yetcites [41] Schlaff WD. Barriers to conducting clinical research in reproductive medicine around the world. Fertil Steril. 2011;96:801. source
- Not checked yetcites [47] Ranasinghe I, Rong Y, Du X, et al. System barriers to the evidence-based Care of Acute Coronary Syndrome (ACS) patients in China: a qualitative analysis. Heart, Lung Circ. 2011;20:S217. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“After removing duplicates, the topic and abstracts of 1915 published articles were screened to check if they were eligible for this review. 1900 articles were excluded as they were out of the scope of this review (see Fig. 1), leaving ten studies reported in fifteen papers to be analysed [40–53].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results
What the sources say
- Not checked yetcites [40] Seruga B, Sadikov A, Cazap EL, et al. Barriers and challenges to global clinical cancer research. Oncologist. 2014;19:61–7. source
- Not checked yetcites [41] Schlaff WD. Barriers to conducting clinical research in reproductive medicine around the world. Fertil Steril. 2011;96:801. source
- Not checked yetcites [42] Pai H. Barriers to conducting clinical research in reproductive medicine: India. Fertil Steril. 2011;96:809–10. source
- Not checked yetcites [43] Aboulghar M. Barriers to conducting clinical research in reproductive medicine: Egypt. Fertil Steril. 2011;96:805–6. source
- Not checked yetcites [44] Chen Z-J. Barriers to conducting clinical research in reproductive medicine: China. Fertil Steril. 2011;96:811–2. source
- Not checked yetcites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source
- Not checked yetcites [46] Siegfried N, Volmink J, Dhansay A. Does South Africa need a national clinical trials support unit? SAMJ: S. Afr. Med. J. 2010;100:521–4. source
- Not checked yetcites [47] Ranasinghe I, Rong Y, Du X, et al. System barriers to the evidence-based Care of Acute Coronary Syndrome (ACS) patients in China: a qualitative analysis. Heart, Lung Circ. 2011;20:S217. source
- Not checked yetcites [48] Franzen SR, Chandler C, Enquselassie F, et al. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia. BMJ Open. 2013;3:e003616. source
- Not checked yetcites [49] Franzen SR, Chandler C, Atashili J, Angus B, Lang T. Barriers and enablers of locally led clinical trials in Ethiopia and Cameroon: a prospective, qualitative study. Lancet. 2013;382:14. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Of ten articles included studies, six used qualitative methods [41, 46–50] such as focus group discussion and individual interviews, and four articles [40, 51–53] used quantitative methods.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Selected studies
What the sources say
- Not checked yetcites [41] Schlaff WD. Barriers to conducting clinical research in reproductive medicine around the world. Fertil Steril. 2011;96:801. source
- Not checked yetcites [46] Siegfried N, Volmink J, Dhansay A. Does South Africa need a national clinical trials support unit? SAMJ: S. Afr. Med. J. 2010;100:521–4. source
- Not checked yetcites [47] Ranasinghe I, Rong Y, Du X, et al. System barriers to the evidence-based Care of Acute Coronary Syndrome (ACS) patients in China: a qualitative analysis. Heart, Lung Circ. 2011;20:S217. source
- Not checked yetcites [48] Franzen SR, Chandler C, Enquselassie F, et al. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia. BMJ Open. 2013;3:e003616. source
- Not checked yetcites [49] Franzen SR, Chandler C, Atashili J, Angus B, Lang T. Barriers and enablers of locally led clinical trials in Ethiopia and Cameroon: a prospective, qualitative study. Lancet. 2013;382:14. source
- Not checked yetcites [50] Cardoso A, Breugelmans G, Manville C, Chataway J, Cochrane G, Snodgrass J. Africa mapping: current state of health research on poverty-related and neglected infectious diseases in sub-Saharan Africa.[internet]. 2014 [cited 2015 Jun 28].
- Not checked yetcites [40] Seruga B, Sadikov A, Cazap EL, et al. Barriers and challenges to global clinical cancer research. Oncologist. 2014;19:61–7. source
- Not checked yetcites [51] Gómez HL, Pinto JA, Castañeda C, Vallejos CS. Current barriers for developing clinical research in Latin America: a cross-sectional survey of medical oncologists. Clin Res. 2015;1:22–8.
- Not checked yetcites [52] Sulthan N. Perception of clinical research among clinical investigators in Saudi Arabia. Asian J. Pharm. Clin. Res. 2015;8:243–6.
- Not checked yetcites [53] Al-Dorzi HM, Naidu B, Khokhar S, White D, Arabi YM. Research experience, interest and perceived barriers of clinical staff working at the intensive care department of a tertiary care academic hospital in Saudi Arabia. Middle East J Anesthesiol. 2013;22:301–7.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Two of the studies included in this review [40, 41] were global studies. Though these studies had a global focus, they assessed and clearly presented their results regarding barriers and facilitators of clinical trials in developing countries.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Selected studies
What the sources say
- Not checked yetcites [40] Seruga B, Sadikov A, Cazap EL, et al. Barriers and challenges to global clinical cancer research. Oncologist. 2014;19:61–7. source
- Not checked yetcites [41] Schlaff WD. Barriers to conducting clinical research in reproductive medicine around the world. Fertil Steril. 2011;96:801. source
boosted- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“One study [41] included seven countries (four from low and middle income countries (LMIC) and three from high income countries (HIC)), with a separate publication of the responses from each of the representatives of included countries. Therefore, we included the four papers from LMIC [42–45].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Results > Selected studies
What the sources say
- Not checked yetcites [41] Schlaff WD. Barriers to conducting clinical research in reproductive medicine around the world. Fertil Steril. 2011;96:801. source
- Not checked yetcites [42] Pai H. Barriers to conducting clinical research in reproductive medicine: India. Fertil Steril. 2011;96:809–10. source
- Not checked yetcites [43] Aboulghar M. Barriers to conducting clinical research in reproductive medicine: Egypt. Fertil Steril. 2011;96:805–6. source
- Not checked yetcites [44] Chen Z-J. Barriers to conducting clinical research in reproductive medicine: China. Fertil Steril. 2011;96:811–2. source
- Not checked yetcites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In addition, several other themes emerged from the research literature: ethical and regulatory system obstacles, lack of research environment, operational barriers, and competing demands.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Lengthy ethical and regulatory review time created delays in implementing grants and sometimes led grants to expire before recruitment started.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“A recent review indicated that about one-third of 509 clinical trials sponsored by US-based companies from 1995 to 2005 were conducted outside the USA, many in poor and low-income countries [19], without targeting diseases prevalent in these countries.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Introduction
What the sources say
- Not checked yetcites [19] Glickman SW, McHutchison JG, Peterson ED, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360:816–23. source
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Through the group discussion, abstracted key concepts and subsequent themes were examined and changes made as necessary. This process was repeated until consensus was reached regarding the sufficiency and appropriateness of the themes and subthemes developed to explain barriers for conducting clinical trials in developing countries.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Methods > Data extraction and synthesis
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Eligible papers were assessed by two independent reviewers (CMA, JN) for methodological validity prior to inclusion in the review.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Methods > Assessment of methodological quality
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
In the paper
“Critical appraisal of qualitative studies was made using criteria proposed by Kuper [35].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Methods > Assessment of methodological quality
What the sources say
- Not checked yetcites [35] Kuper A, Lingard L, Levinson W. Critically appraising qualitative research. BMJ. 2008;337:a1035–a. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Titles and abstracts of all the retrieved bibliographic records were screened two independent reviewers (CMA, JN).”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Methods > Search strategy
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Any disagreements that arose between the reviewers were resolved through discussion, or with a third reviewer (GM).”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Methods > Assessment of methodological quality
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“First two reviewers (CM and JN) independently identified key concepts, then compared and analyzed them to identify predominant/recurrent themes across studies.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Methods > Data extraction and synthesis
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may state two separate claims as one.
In the paper
“These countries host nearly 90% of the worldwide burden of disease, most of which comprises preventable infectious diseases [2].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Introduction
What the sources say
- Not checked yetcites [2] Murray CJ, Lopez AD. Global comparative assessments in the health sector: disease burden, expenditures and intervention packages. 1994.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“A systematic review of barriers for conducting clinical trials by clinicians in developed countries identified several major barriers. These include time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Introduction
What the sources say
- Not checked yetcites [24] Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52:1143–56. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“They are more demand-led, influence policy and responsive to a country’s needs because they are driven by a local or national agenda.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Abstract > Conclusion and recommendation
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper may give no reason why it holds. It may state two separate claims as one.
In the paper
“Barriers for conducting clinical trial vary between countries, and barriers to conducting clinical trials not normally considered by research institutes (local structural, infrastructural, and procedural aspects) may affect investigators more in poorer settings than in developed countries [25].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Introduction
What the sources say
- Not checked yetcites [25] Govindarajan R, Young JW, Harless CL, Hutchins LF. Barriers to clinical trials vary according to the type of trial and the institution. J. Clin. Oncol. : J. Am. Soc. Clin. Oncol. 2007;25:1633–4. author reply 4 source
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“These countries are under-represented in research due to lack of commercial viability and research capacity [6, 7]”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Introduction
What the sources say
- Not checked yetcites [6] Røttingen J-A, Chamas C, Goyal L, Harb H, Lagrada L, Mayosi BM. Securing the public good of health research and development for developing countries. Bull World Health Organ. 2012;90:398–400. source
- Not checked yetcites [7] Moon S, Bermudez J, Hoen E. Innovation and access to medicines for neglected populations: could a treaty address a broken pharmaceutical R&D system? PLoS Med. 2012;9:e1001218. source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Quality of each selected quantitative study was assessed using criteria adapted from the Newcastle-Ottawa scale for cross-sectional studies [34].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Methods > Assessment of methodological quality
What the sources say
- Not checked yetcites [34] Auad APHADOCMMPAPM. Quality assessment criteria used for cross-sectional studies through a modified version of Newcastle-Ottawa scale for observational studies. 2014.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“In 2015, a review findings regarding the distribution of global clinical trials was released [33]. This report concluded that despite the overall increase in clinical trials over the last two decades, the progress of clinical trials in developing countries was particularly slow and challenging.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Methods > Eligibility criteria
What the sources say
- Not checked yetcites [33] Li R, Barnes M, Aldinger C, Bierer B. Global clinical trials: ethics, harmonization and commitments to transparency. Global Health. 2015;4(1):2. http://harvardpublichealthreview.org/global-clinical-trials-ethics-harmonization-and-commitments-to-transparency/ . source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“To avoid potential restrictions (from using predetermined themes) and to allow the possibility of including emergent key concepts, we used the study findings themselves to conduct a thematic analysis.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Methods > Data extraction and synthesis
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may state two separate claims as one.
In the paper
“In the early 1990’s, the commission stated that the rapid expansion of country-specific health research to meet health needs of these countries was a necessity to encourage better health status for more people in settings with sometimes severely limited resources [32].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Methods > Eligibility criteria
What the sources say
- Not checked yetcites [32] Evans JR. Essential national health research: a key to equity in development. Mass Medical Soc. N Engl J Med. 1990;323(13):913–5. source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“In 1995, WHO published Guidelines for Good Clinical Practice [11], the world’s first standard for reporting clinical trials.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Methods > Eligibility criteria
What the sources say
- Not checked yetcites [11] WHO Expert Committee. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products, the use of essential drugs. Sixth report of the WHO expert committee. Geneva: WHO Technical Report Series; 1995.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“In India for example, though there are half a million physicians with 50–60 physicians per 100,000 people, fewer than 200 have been trained in Good Clinical Practice (GCP) [55].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [55] Nundy S, Gulhati CM. A new colonialism? Conducting clinical trials in India. N Engl J Med. 2005;352:1633–6. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Another systematic review identified barriers as system-organization barriers (time involvement and resource issues), trial design-related barriers, and physician-related barriers [56].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [56] Fayter D, Mcdaid C, Ritchie G, Stirk L, Eastwood A. Systematic review of barriers, modifiers and benefits involved in participation in cancer clinical trials. Geneva: University of York; 2006.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“The purpose of the quality assessment was not to establish thresholds below which studies were excluded, rather to distinguish between studies in terms of overall contribution to the review [36].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Methods > Assessment of methodological quality
What the sources say
- Not checked yetcites [36] Lorenc T, Petticrew M, Whitehead M, et al. Quality assessment for the systematic review of qualitative evidence. 2014.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Ethical and regulatory issues, administrative issues, lack of finance, lack of infrastructure, poor data quality, and lack of training curricula focusing on clinical research were the major bottlenecks [58, 59].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [58] Mbuagbaw L, Thabane L, Ongolo-Zogo P, Lang T. The challenges and opportunities of conducting a clinical trial in a low resource setting: the case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial. Trials. 2011;12:145. source
- Not checked yetcites [59] Julka P. Clinical trials in India: dilemmas for developing countries. Issues Clin Res. 2007:69–71.
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“This is reflective of the 10/90 gap, in which less than 10% of health research funds in the world are directed toward problems that affect 90% of the world’s population, and an even smaller percentage go to fund researchers and health problems indigenous to developing countries [6, 7, 61].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [6] Røttingen J-A, Chamas C, Goyal L, Harb H, Lagrada L, Mayosi BM. Securing the public good of health research and development for developing countries. Bull World Health Organ. 2012;90:398–400. source
- Not checked yetcites [7] Moon S, Bermudez J, Hoen E. Innovation and access to medicines for neglected populations: could a treaty address a broken pharmaceutical R&D system? PLoS Med. 2012;9:e1001218. source
- Not checked yetcites [61] Research GFfH. The 10/90 report on health research 2000. Geneva: Global Forum for Health Research c/o World Health Organization; 2000.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“By contrast, a systematic review related to physician barriers in RCTs for cancer and other illnesses in the developed world identified lack of time as a major barrier [24].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [24] Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52:1143–56. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“The authors reported that the regulatory processes in resource limited countries hinder the efficient implementation of multi-site clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [60] Ndebele P, Blanchard-Horan C, Shahkolahi A, Sanne I. Regulatory challenges associated with conducting multi-country clinical trials in resource-limited settings. J. Acquir. Immune Defic. Syndr. (1999). 2014;65:S29. source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may state two separate claims as one.
In the paper
“only 1% of the recently discovered drugs are aimed at management of tropical diseases [55]”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [55] Nundy S, Gulhati CM. A new colonialism? Conducting clinical trials in India. N Engl J Med. 2005;352:1633–6. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“Such human resource development requires relatively stable, well-resourced research and higher education institutes, and well established science governance systems, which is not the case in developing countries [62].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [62] Gaillard J. Measuring Research and Development in developing countries main characteristics and implications for the Frascati manual. Sci. Technol. Soc. 2010;15:77–111. source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“The number of registered international clinical trials that include India have increased by 30% each year for the past three consecutive years for many of the reasons outlined above [79, 80].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [79] Jain R, Stern D. Effective utilisation of India for global clinical trials. J. Clin. Stud. 2011;3:30–64.
- Not checked yetcites [80] Bhowmik D, Biswajit C, Jaiswal J, Tripathi K. Recent emerging hub for global clinical research in India. J. Glob. Pharma Technol. 2010;2(1):30–44.
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Rests on an assumption: India is one of the world’s fastest-growing clinical research destinations.
In the paper
“For example, one systematic review regarding barriers for participation of doctors in clinical trials in developed countries identified lack of time as a major barrier [24].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [24] Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52:1143–56. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“The Global Forum for Health Research report emphasized that strengthening research capacity in developing countries is one of the most effective and sustainable ways of advancing health and development in these countries and of helping correct the 10/90 gap in health research [61].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [61] Research GFfH. The 10/90 report on health research 2000. Geneva: Global Forum for Health Research c/o World Health Organization; 2000.
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“A recent review indicated that about one-third of 509 clinical trials sponsored by US-based companies from 1995 to 2005 were conducted outside the USA, many in poor and low-income countries [19].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [19] Glickman SW, McHutchison JG, Peterson ED, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360:816–23. source
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“For example in Europe, because of the substantial increase in costs and administrative burdens for implementation, international collaboration in academia-driven clinical research has decreased [71].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [71] Druml C, Singer E, Wolzt M. Report of the 1st meeting of the “Vienna initiative to save European academic research (VISAER)”. Wien Klin Wochenschr. 2006;118:Suppl 1–12. source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“These are all very important barriers for sponsors and researchers as they may directly influence the time and budget allocated to run trials.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
None of the sources cited for this claim have been checked yet.
In the paper
“Other studies also reported numbers of qualified researchers not reaching critical mass, inadequate research infrastructure, and inconsistent and limited funding opportunities [64, 65] as factors that hampered the conduct of research in these countries.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [64] Whitworth JA, Kokwaro G, Kinyanjui S, et al. Strengthening capacity for health research in Africa. Lancet. 2008;372:1590–3. source
- Not checked yetcites [65] Zumla A, Huggett J, Dheda K, Green C, Kapata N, Mwaba P. Trials and tribulations of an African-led research and capacity development programme: the case for EDCTP investments. Tropical Med Int Health. 2010;15:489–94.
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Besides, they are more likely to influence policy and sustainably link research to action [78].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [78] Zucker D, Schmid C, McIntosh M, D'Agostino R, Selker H, Lau J. Combining single patient (N-of-1) trials to estimate population treatment effects and to evaluate individual patient responses to treatment. J Clin Epidemiol. 1997;50:401–10. source
hedgedcorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“It is obvious that most of the developing countries were hardly represented in the literature.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
boosted- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper may give no reason why it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“Other studies also reported lengthy or ill-defined approval processes, significant bureaucracy, and lack of regulatory staff with expertise in reviewing [66, 67].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [66] Kochhar S. Challenges and impact of conducting vaccine trials in Asia and Africa: new Technologies in Emerging Markets, October 16th-18th 2012; world vaccine congress, Lyon. Hum. Vacci. Immunother. 2013;9:924–7. source
- Not checked yetcites [67] Gupta S, Nag S, Dawood S. Challenges and opportunities in the design and implementation of breast cancer clinical trials in developing countries. Clin. Investig. 2012;2:579–87. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“European experience showed that over-management and over-regulation might negatively affect research and how important it is to harmonize and not overregulate the field of clinical research [68, 69].”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
What the sources say
- Not checked yetcites [68] Hearn J, Sullivan R. The impact of the ‘clinical trials’ directive on the cost and conduct of non-commercial cancer trials in the UK. Eur J Cancer. 2007;43:8–13. source
- Not checked yetcites [69] Sullivan R. The good, the bad, and the ugly: effect of regulations on cancer research. Lancet Oncol. 2008;9:2–3. source
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“However, we believe the rigorous compilation of stakeholder view and experiences lays the foundation to guide future studies.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Similarly, concerns may be different for foreign led versus local investigator initiated trials.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Conclusion
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper may give no reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Barriers may vary widely depending on the context in which the clinical trials are conducted.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Most of the included studies were qualitative studies with small sample size and narrow diversity of participants.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“There are several inter-country differences in culture, socioeconomic and political contexts, therefore our findings may not reflect the situation in any specific country.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Rests on an assumption: There are several inter-country differences in culture, socioeconomic and political contexts.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“We excluded papers which were not written in English. This is because the cost of translation was not feasible.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Because of the limited number of articles in the review, our analysis did not examine the similarities and differences between barriers among the different developing countries.”
§ Barriers for conducting clinical trials in developing countries- a systematic review > Discussion
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
The paper relies on this without support.
Scarce resources in developing countries are nearly all spent on program implementation, and allocating funds for research is almost out of the equation in most development plans.
“Scarce resources in developing countries are nearly all spent on program implementation, and allocating funds for research is almost out of the equation in most development plans.”
The paper relies on this without support.
Medical schools and teaching hospitals in LMIC have poorly prepared their graduates to conduct scientific trials and clinical research.
“Medical schools and teaching hospitals in LMIC have poorly prepared their graduates to conduct scientific trials and clinical research.”
The paper relies on this without support.
Most clinicians around the world have competing priorities that require them to engage in caring for patients.
“It is well known that most clinicians around the world have competing priorities that require them to engaging on caring for patients.”
The paper relies on this without support.
Physicians in the developing world are already overstretched with responsibilities of patient care.
“Physicians in the developing world are already overstretched with responsibilities of patient care.”
The paper relies on this without support.
The availability of large numbers of tertiary qualified workers and the relatively low salary base in developing countries reduces the cost of running clinical trials.
“Moreover, the availability of large numbers of tertiary qualified workers and the relatively low salary base in these countries reduces the cost of running clinical trials.”
The paper relies on this without support.
International clinical trials often cost less than they do in the US.
“One reason for outsourcing is that international clinical trials often cost less than they do in the US.”
The paper relies on this without support.
There are several inter-country differences in culture, socioeconomic and political contexts.
“There are several inter-country differences in culture, socioeconomic and political contexts”
The paper relies on this without support.
India is one of the world’s fastest-growing clinical research destinations.
“For example, India is one of the world’s fastest-growing clinical research destinations.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“Moreover, biobanking and repository research are being scrutinized and restricted more harshly [196,197].”
From Recent Advances in Therapeutics for the Treatment of Alzheimer’s Disease (2024) · cites this paper as [197]
In the citing paper
“One of the regulatory obstacles in creating DMTs for AD is the insufficient knowledge and ability of regional regulatory organizations, in addition to post-study medication administration and sustained treatment supply.”
From Recent Advances in Therapeutics for the Treatment of Alzheimer’s Disease (2024) · cites this paper as [197]
In the citing paper
“Moreover, there are several review levels with conflicting results and different guidelines for participant reimbursement for trial-related injuries.”
From Recent Advances in Therapeutics for the Treatment of Alzheimer’s Disease (2024) · cites this paper as [197]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ Barriers for conducting clinical trials in developing countries- a systematic review > References
“9. Mbuagbaw L Thabane L Ongolo-Zogo P Lang T The challenges and opportunities of conducting a clinical trial in a low resource setting: the case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial Trials 2011 12 1 10.1186/1745-6215-12-1 21658262 PMC3138444”
§ Barriers for conducting clinical trials in developing countries- a systematic review > References
“58. Mbuagbaw L Thabane L Ongolo-Zogo P Lang T The challenges and opportunities of conducting a clinical trial in a low resource setting: the case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial Trials 2011 12 145 10.1186/1745-6215-12-145 21658262 PMC3138444”
Citations
Cites
Liberati, A., Altman, D. G., Tetzlaff, J., Mulrow, C., Gøtzsche, P. C., Ioannidis, J. P. A., Clarke, M., Devereaux, P. J., Kleijnen, J., & Moher, D. (2009) · PLoS Medicine · doi:10.1371/journal.pmed.1000100 · Cited by 28,164 · cited 1×
“This review is prepared based on the Preferred Reporting Items for Systematic Reviews and Meta- Analyses (PRISMA) statement checklist and flow diagram [30], modified for health service reviews [31].”
MethodLiberati, A., Altman, D. G., Tetzlaff, J., Mulrow, C., Gøtzsche, P. C., Ioannidis, J. P. A., Clarke, M., Devereaux, P. J., Kleijnen, J., & Moher, D. (2009) · Annals of Internal Medicine · doi:10.7326/0003-4819-151-4-200908180-00136 · Cited by 10,349
Methods for the thematic synthesis of qualitative research in systematic reviews
Thomas, J., & Harden, A. (2008) · BMC Medical Research Methodology · doi:10.1186/1471-2288-8-45 · Cited by 9,312
Global status report on noncommunicable diseases 2010.
Alwan, A. (2011) · Cited by 8,494
Reprint—Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement
Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., & and the PRISMA Group (2009) · Physical Therapy · doi:10.1093/ptj/89.9.873 · Cited by 2,486 · cited 2×
“This review is prepared based on the Preferred Reporting Items for Systematic Reviews and Meta- Analyses (PRISMA) statement checklist and flow diagram [30], modified for health service reviews [31].”
MethodDivision, U. P. (1991) · Cited by 1,434
Using meta ethnography to synthesise qualitative research: a worked example
Britten, N., Campbell, R., Pope, C., Donovan, J., Morgan, M., & Pill, R. (2002) · Journal of Health Services Research & Policy · doi:10.1258/135581902320432732 · Cited by 1,110 · cited 1×
“However, due to the widely diverse settings as well as variations in methodological approaches across studies (which are important considerations in developing a more generalized model [38, 39]), we did not conduct a meta-synthesis.”
BackgroundWhat Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research
Emanuel, E. J., Wendler, D., Killen, J., & Grady, C. (2004) · The Journal of Infectious Diseases · doi:10.1086/381709 · Cited by 966
Barriers to Participation in Randomised Controlled Trials
Ross, S., Grant, A., Counsell, C., Gillespie, W., Russell, I., & Prescott, R. (1999) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(99)00141-9 · Cited by 907 · cited 1×
“These include time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting question [24].”
BackgroundThe Ethics of Clinical Research in the Third World
Angell, M. (1997) · New England Journal of Medicine · doi:10.1056/nejm199709183371209 · Cited by 863
Research works printed but not linked: 3
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- Sulthan N. Perception of clinical research among clinical investigators in Saudi Arabia. Asian J. Pharm. Clin. Res. 2015;8:243–6.
- Jain R, Stern D. Effective utilisation of India for global clinical trials. J. Clin. Stud. 2011;3:30–64.
Cited by
Sorted by citations
Medications safety research issues
Al‐Worafi, Y. M. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-819837-7.00019-4 · Cited by 383
The economic burden of dementia in low- and middle-income countries (LMICs): a systematic review
Mattap, S. M., Mohan, D., McGrattan, A. M., Allotey, P., Stephan, B. C., Reidpath, D. D., Siervo, M., Robinson, L., & Chaiyakunapruk, N. (2022) · BMJ Global Health · doi:10.1136/bmjgh-2021-007409 · Cited by 182
Wells, J. C., Sharma, S. M., Paggio, J. C. D., Hopman, W. M., Gyawali, B., Mukherji, D., Hammad, N., Pramesh, C. S., Aggarwal, A. K., Sullivan, R. J., et al. (2021) · JAMA Oncology · doi:10.1001/jamaoncol.2020.7478 · Cited by 177
Decolonising global health: transnational research partnerships under the spotlight
Lawrence, D. S., & Hirsch, L. A. (2020) · International Health · doi:10.1093/inthealth/ihaa073 · Cited by 130
Global Cancer Surgery: pragmatic solutions to improve cancer surgery outcomes worldwide
Are, C., Murthy, S. S., Sullivan, R. J., Schissel, M. E., Chowdhury, S., Alatise, O., Anaya, D., Are, M., Balch, C. M., Bartlett, D. L., et al. (2023) · The Lancet Oncology · doi:10.1016/s1470-2045(23)00412-6 · Cited by 101
Metadata
- Authors
- Alemayehu, C., Mitchell, G., & Nikles, J.
- Affiliations
- The University of Queensland (AU)
- Corresponding author
- Alemayehu, Chalachew
- Venue
- International Journal for Equity in Health
- Published
- 2018-03-22
- Volume
- 17
- Issue
- 1
- Pages
- 37-37
- ISSN
- 1475-9276 (ISSN-L)
- PMC
- PMC5863824
- OpenAlex
- W2799784802
- Semantic Scholar
- fc66121908db044c0655688161c7a8dd746c3eca
- Cited by
- 406
- References
- 80
- Citations by year
- 2026: 65 · 2025: 74 · 2024: 70 · 2023: 62 · 2022: 47 · 2021: 48 · 2020: 25 · 2019: 15
- FWCI
- 3.99
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- International Journal for Equity in Health (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- University of Queensland
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Global Health and Surgery
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health and Medical Research Impacts
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Keywords
- barriers to clinical trials, developing countries, investigator-initiated trials, research capacity, research environment, health disparities, underrepresentation in clinical trials, operational barriers, competing demands
- MeSH terms
- Attitude to Health, Clinical Trials as Topic, Communication Barriers, Developing Countries, Humans, Research Support as Topic
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
A language model drew the claims from the paper on 2026-10-10, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).
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Cited sources are checked with a language model’s help (gpt-6-sol).
Statistics and arithmetic are recomputed, not judged.
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