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Cited by 406Global Health and SurgeryHealth and Medical Research ImpactsEthics in Clinical Research

Barriers for conducting clinical trials in developing countries—A systematic review

Open access
Alemayehu, Chalachew, Mitchell, Geoffrey, Nikles, Jane·2018·International Journal for Equity in Health
DOI 10.1186/s12939-018-0748-6PMC PMC5863824
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Abstract

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.

AI snapshot

Written from the paper’s full text.

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.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1186/s12939-018-0748-6

Cites

78 of 78 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 172 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    The review identified five unifying themes for barriers to conducting clinical trials in developing countries: lack of financial and human capacity, ethical and regulatory system obstacles, lack of research environment, operational barriers, and competing demands.

    “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.”
    Quote in the paperSubstantial claim
  • Findingcitation

    Absence of suitable research infrastructure was stated by many articles.

    “Absence of suitable research infrastructure was stated by many articles [45, 47–50].”
    Quote in the paperNot a substantial claim0 of 5 sources checked
    • cites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source

      Not checked in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

  • Findingcitation

    One medium-quality study had a low response rate (92 out of 404-23%).

    “Of the medium quality studies, one had a low response rate (92 out of 404–23%) [51].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [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 in the free run.

  • Findingcitation

    Four articles reported that the presence of unskilled authorities in the review process posed a barrier to conducting clinical trials.

    “Four articles reported that the presence of unskilled authorities in the review process posed a barrier to conducting clinical trials [42, 45, 48, 49].”
    Quote in the paperNot a substantial claim0 of 4 sources checked
    • cites [42] Pai H. Barriers to conducting clinical research in reproductive medicine: India. Fertil Steril. 2011;96:809–10. source

      Not checked in the free run.

    • cites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source

      Not checked in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

  • Findingcitation

    Limited capacity in terms of funding was reported in all included studies except two conducted in Saudi Arabia.

    “Limited capacity in terms of funding were reported in all except two [52, 53] studies conducted in Saudi Arabia [52, 53].”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [52] Sulthan N. Perception of clinical research among clinical investigators in Saudi Arabia. Asian J. Pharm. Clin. Res. 2015;8:243–6.

      Not checked in the free run.

    • cites [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 in the free run.

  • Classified as probably not a substantial claim. 37
  • May combine two claims. 43

  • Classified as probably not a substantial claim.

    Findingnone given

    The key findings were similar across studies.

    “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.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Ten studies, reported in 15 papers, were included in this review.

    “Ten studies, which are reported in 15 papers, were included in this review.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Of the four quantitative studies, one was high quality, two were medium quality and one was low quality.

    “Of the four quantitative studies, one study was high quality, two were medium quality and one was low quality.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingcitation

    The low-quality study showed a high risk of selection bias secondary to purposive sampling procedure for participant selection as well as a low response rate (27%), and a comparison between respondents and non-respondents was not provided.

    “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]”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [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 in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingcitation

    One study stated that it was not uncommon for grants to expire before all approvals were in place.

    “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.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingcitation

    In one medium-quality study, sample size was not justified and there was no description of the sampling strategy.

    “In the other study, sample size was not justified and there is no description of the sampling strategy [52].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [52] Sulthan N. Perception of clinical research among clinical investigators in Saudi Arabia. Asian J. Pharm. Clin. Res. 2015;8:243–6.

      Not checked in the free run.

  • May combine two claims.

    Findingown data

    Financial and human capital barriers were reported across all articles.

    “Financial and human capital barriers were reported across all articles.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The proposal that led to publication of participants' views from each represented country 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.

    “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”
    Quote in the paperNot a substantial claim0 of 5 sources checked
    • cites [41] Schlaff WD. Barriers to conducting clinical research in reproductive medicine around the world. Fertil Steril. 2011;96:801. source

      Not checked in the free run.

    • cites [42] Pai H. Barriers to conducting clinical research in reproductive medicine: India. Fertil Steril. 2011;96:809–10. source

      Not checked in the free run.

    • cites [43] Aboulghar M. Barriers to conducting clinical research in reproductive medicine: Egypt. Fertil Steril. 2011;96:805–6. source

      Not checked in the free run.

    • cites [44] Chen Z-J. Barriers to conducting clinical research in reproductive medicine: China. Fertil Steril. 2011;96:811–2. source

      Not checked in the free run.

    • cites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    Both lack of skilled personnel and lack of awareness and motivation to participate were reported as human capacity barriers.

    “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.”
    Quote in the paperNot a substantial claim0 of 10 sources checked
    • cites [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 in the free run.

    • cites [42] Pai H. Barriers to conducting clinical research in reproductive medicine: India. Fertil Steril. 2011;96:809–10. source

      Not checked in the free run.

    • cites [44] Chen Z-J. Barriers to conducting clinical research in reproductive medicine: China. Fertil Steril. 2011;96:811–2. source

      Not checked in the free run.

    • cites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source

      Not checked in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [52] Sulthan N. Perception of clinical research among clinical investigators in Saudi Arabia. Asian J. Pharm. Clin. Res. 2015;8:243–6.

      Not checked in the free run.

    • cites [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 in the free run.

    • cites [43] Aboulghar M. Barriers to conducting clinical research in reproductive medicine: Egypt. Fertil Steril. 2011;96:805–6. source

      Not checked in the free run.

  • May combine two claims.

    Findingown data

    Four of the ten included studies reported findings from health professionals, and the remaining six involved health researchers.

    “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].”
    Quote in the paperNot a substantial claim0 of 10 sources checked
    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [41] Schlaff WD. Barriers to conducting clinical research in reproductive medicine around the world. Fertil Steril. 2011;96:801. source

      Not checked in the free run.

    • cites [42] Pai H. Barriers to conducting clinical research in reproductive medicine: India. Fertil Steril. 2011;96:809–10. source

      Not checked in the free run.

    • cites [43] Aboulghar M. Barriers to conducting clinical research in reproductive medicine: Egypt. Fertil Steril. 2011;96:805–6. source

      Not checked in the free run.

    • cites [44] Chen Z-J. Barriers to conducting clinical research in reproductive medicine: China. Fertil Steril. 2011;96:811–2. source

      Not checked in the free run.

    • cites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source

      Not checked in the free run.

    • cites [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 in the free run.

  • May combine two claims.

    Findingown data

    With the exception of concerns around time, reported barriers for conducting clinical trials were similar between health professionals and health researchers, with financial and human barriers being the most common in both groups.

    “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.”
    Quote in the paperNot a substantial claim0 of 4 sources checked
    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

  • May combine two claims.

    Findingcitation

    Lack of research materials for conducting clinical trials and lack of conducive scientific atmosphere (including policy) were reported.

    “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.”
    Quote in the paperNot a substantial claim0 of 6 sources checked
    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [43] Aboulghar M. Barriers to conducting clinical research in reproductive medicine: Egypt. Fertil Steril. 2011;96:805–6. source

      Not checked in the free run.

    • cites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source

      Not checked in the free run.

    • cites [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 in the free run.

  • May combine two claims.

    Findingown data

    There was considerable variation regarding lack of time as a barrier, with most (3 out of 4) studies that reported views of health professionals putting more emphasis on lack of time and only one study that involved clinical researchers reporting lack of time as a barrier.

    “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.”
    Quote in the paperNot a substantial claim0 of 4 sources checked
    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    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.

    “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.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Six (60%) of included studies assessed barriers of conducting clinical trials on non-specific health conditions; the remaining four assessed barriers in cancer, reproductive disease and acute coronary syndrome.

    “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].”
    Quote in the paperNot a substantial claim0 of 4 sources checked
    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [41] Schlaff WD. Barriers to conducting clinical research in reproductive medicine around the world. Fertil Steril. 2011;96:801. source

      Not checked in the free run.

    • cites [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 in the free run.

  • May combine two claims.

    Findingown data

    After removing duplicates, 1915 published articles were screened, 1900 were excluded as out of scope, leaving ten studies reported in fifteen papers to be analysed.

    “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].”
    Quote in the paperSubstantial claim0 of 10 sources checked
    • cites [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 in the free run.

    • cites [41] Schlaff WD. Barriers to conducting clinical research in reproductive medicine around the world. Fertil Steril. 2011;96:801. source

      Not checked in the free run.

    • cites [42] Pai H. Barriers to conducting clinical research in reproductive medicine: India. Fertil Steril. 2011;96:809–10. source

      Not checked in the free run.

    • cites [43] Aboulghar M. Barriers to conducting clinical research in reproductive medicine: Egypt. Fertil Steril. 2011;96:805–6. source

      Not checked in the free run.

    • cites [44] Chen Z-J. Barriers to conducting clinical research in reproductive medicine: China. Fertil Steril. 2011;96:811–2. source

      Not checked in the free run.

    • cites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source

      Not checked in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    Of ten included studies, six used qualitative methods and four used quantitative methods.

    “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.”
    Quote in the paperNot a substantial claim0 of 10 sources checked
    • cites [41] Schlaff WD. Barriers to conducting clinical research in reproductive medicine around the world. Fertil Steril. 2011;96:801. source

      Not checked in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [52] Sulthan N. Perception of clinical research among clinical investigators in Saudi Arabia. Asian J. Pharm. Clin. Res. 2015;8:243–6.

      Not checked in the free run.

    • cites [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 in the free run.

  • May combine two claims.

    Findingreasoning

    Two of the included studies were global studies, and though they had a global focus, they assessed and clearly presented their results regarding barriers and facilitators of clinical trials in developing countries.

    “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.”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [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 in the free run.

    • cites [41] Schlaff WD. Barriers to conducting clinical research in reproductive medicine around the world. Fertil Steril. 2011;96:801. source

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    One study included seven countries (four from LMIC and three from HIC), with separate publication of responses from each country; the four papers from LMIC were included.

    “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].”
    Quote in the paperNot a substantial claim0 of 5 sources checked
    • cites [41] Schlaff WD. Barriers to conducting clinical research in reproductive medicine around the world. Fertil Steril. 2011;96:801. source

      Not checked in the free run.

    • cites [42] Pai H. Barriers to conducting clinical research in reproductive medicine: India. Fertil Steril. 2011;96:809–10. source

      Not checked in the free run.

    • cites [43] Aboulghar M. Barriers to conducting clinical research in reproductive medicine: Egypt. Fertil Steril. 2011;96:805–6. source

      Not checked in the free run.

    • cites [44] Chen Z-J. Barriers to conducting clinical research in reproductive medicine: China. Fertil Steril. 2011;96:811–2. source

      Not checked in the free run.

    • cites [45] Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fertil Steril. 2011;96:802–4. source

      Not checked in the free run.

  • May combine two claims.

    Findingown data

    Several other themes emerged from the research literature: ethical and regulatory system obstacles, lack of research environment, operational barriers, and competing demands.

    “In addition, several other themes emerged from the research literature: ethical and regulatory system obstacles, lack of research environment, operational barriers, and competing demands.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingreasoning

    Lengthy ethical and regulatory review time created delays in implementing grants and sometimes led grants to expire before recruitment started.

    “Lengthy ethical and regulatory review time created delays in implementing grants and sometimes led grants to expire before recruitment started.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    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, without targeting diseases prevalent in these countries.

    “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.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [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 in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    The process of identifying key concepts and themes was repeated as a group until consensus was reached regarding sufficiency and appropriateness of themes and subthemes.

    “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.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Eligible papers were assessed by two independent reviewers for methodological validity prior to inclusion in the review.

    “Eligible papers were assessed by two independent reviewers (CMA, JN) for methodological validity prior to inclusion in the review.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    Critical appraisal of qualitative studies was made using criteria proposed by Kuper.

    “Critical appraisal of qualitative studies was made using criteria proposed by Kuper [35].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [35] Kuper A, Lingard L, Levinson W. Critically appraising qualitative research. BMJ. 2008;337:a1035–a. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Titles and abstracts of all retrieved bibliographic records were screened by two independent reviewers.

    “Titles and abstracts of all the retrieved bibliographic records were screened two independent reviewers (CMA, JN).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Any disagreements between reviewers were resolved through discussion, or with a third reviewer.

    “Any disagreements that arose between the reviewers were resolved through discussion, or with a third reviewer (GM).”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductown data

    Two reviewers independently identified key concepts, then compared and analyzed them to identify predominant/recurrent themes across studies.

    “First two reviewers (CM and JN) independently identified key concepts, then compared and analyzed them to identify predominant/recurrent themes across studies.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Developing countries host nearly 90% of the worldwide burden of disease, most of which comprises preventable infectious diseases.

    “These countries host nearly 90% of the worldwide burden of disease, most of which comprises preventable infectious diseases [2].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [2] Murray CJ, Lopez AD. Global comparative assessments in the health sector: disease burden, expenditures and intervention packages. 1994.

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    A systematic review of barriers for conducting clinical trials by clinicians in developed countries identified several major barriers: 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.

    “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”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [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

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S4 (based). May combine two claims.

    Interpretationreasoning

    Local investigator-initiated trials are more demand-led, influence policy and responsive to a country's needs because they are driven by a local or national agenda.

    “They are more demand-led, influence policy and responsive to a country’s needs because they are driven by a local or national agenda.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Barriers for conducting clinical trials vary between countries, and barriers not normally considered by research institutes may affect investigators more in poorer settings than in developed countries.

    “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].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [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

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Developing countries are under-represented in clinical research due to lack of commercial viability and research capacity.

    “These countries are under-represented in research due to lack of commercial viability and research capacity [6, 7]”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [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 in the free run.

    • cites [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 in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    Quality of each selected quantitative study was assessed using criteria adapted from the Newcastle-Ottawa scale for cross-sectional studies.

    “Quality of each selected quantitative study was assessed using criteria adapted from the Newcastle-Ottawa scale for cross-sectional studies [34].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [34] Auad APHADOCMMPAPM. Quality assessment criteria used for cross-sectional studies through a modified version of Newcastle-Ottawa scale for observational studies. 2014.

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    The review was prepared based on the PRISMA statement checklist and flow diagram, modified for health service reviews.

    “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].”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [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

      Not checked in the free run.

    • cites [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

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    In 2015, a review 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.

    “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.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [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

      Not checked in the free run.

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductreasoning

    To avoid potential restrictions from predetermined themes and allow emergent key concepts, the study findings themselves were used to conduct the thematic analysis.

    “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.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The Commission on Health Research for Development stated in the early 1990s that rapid expansion of country-specific health research to meet health needs of developing countries was a necessity to encourage better health status.

    “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].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [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

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    In 1995, WHO published Guidelines for Good Clinical Practice, the world's first standard for reporting clinical trials.

    “In 1995, WHO published Guidelines for Good Clinical Practice [11], the world’s first standard for reporting clinical trials.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [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.

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    In India, fewer than 200 physicians have been trained in Good Clinical Practice (GCP), despite there being half a million physicians with 50-60 physicians per 100,000 people.

    “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].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [55] Nundy S, Gulhati CM. A new colonialism? Conducting clinical trials in India. N Engl J Med. 2005;352:1633–6. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Another systematic review identified system-organization barriers (time involvement and resource issues), trial design-related barriers, and physician-related barriers.

    “Another systematic review identified barriers as system-organization barriers (time involvement and resource issues), trial design-related barriers, and physician-related barriers [56].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [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.

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductcitation

    The quality assessment was not used to establish thresholds below which studies were excluded, but to distinguish between studies in terms of overall contribution to the review.

    “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].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [36] Lorenc T, Petticrew M, Whitehead M, et al. Quality assessment for the systematic review of qualitative evidence. 2014.

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    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 major bottlenecks for conducting clinical trials in developing countries, according to published perspectives of clinical investigators.

    “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].”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [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 in the free run.

    • cites [59] Julka P. Clinical trials in India: dilemmas for developing countries. Issues Clin Res. 2007:69–71.

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    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.

    “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].”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [61] Research GFfH. The 10/90 report on health research 2000. Geneva: Global Forum for Health Research c/o World Health Organization; 2000.

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    A systematic review of physician barriers in RCTs for cancer and other illnesses in the developed world identified lack of time as a major barrier.

    “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].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [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

      Not checked in the free run.

  • Classified as probably not a substantial claim. May combine two claims.

    Premisecitation

    Regulatory processes in resource-limited countries hinder efficient implementation of multi-site clinical trials, delaying research and costing millions of dollars a year.

    “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.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [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

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Only 1% of recently discovered drugs are aimed at management of tropical diseases.

    “only 1% of the recently discovered drugs are aimed at management of tropical diseases [55]”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [55] Nundy S, Gulhati CM. A new colonialism? Conducting clinical trials in India. N Engl J Med. 2005;352:1633–6. source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Human resource development for clinical trials requires relatively stable, well-resourced research and higher education institutes and well-established science governance systems, which is not the case in developing countries.

    “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].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [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

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The number of registered international clinical trials that include India has increased by 30% each year for the past three consecutive years.

    “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].”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [79] Jain R, Stern D. Effective utilisation of India for global clinical trials. J. Clin. Stud. 2011;3:30–64.

      Not checked in the free run.

    • cites [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.

      Not checked in the free run.

    • Rests on an assumption: India is one of the world’s fastest-growing clinical research destinations.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    A systematic review regarding barriers for participation of doctors in clinical trials in developed countries identified lack of time as a major barrier.

    “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].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [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

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Strengthening research capacity in developing countries is one of the most effective and sustainable ways of advancing health and development and helping correct the 10/90 gap in health research.

    “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].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [61] Research GFfH. The 10/90 report on health research 2000. Geneva: Global Forum for Health Research c/o World Health Organization; 2000.

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    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.

    “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].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [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 in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    In Europe, because of substantial increase in costs and administrative burdens for implementation, international collaboration in academia-driven clinical research has decreased.

    “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].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [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

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationreasoning

    These barriers are very important for sponsors and researchers as they may directly influence the time and budget allocated to run trials.

    “These are all very important barriers for sponsors and researchers as they may directly influence the time and budget allocated to run trials.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Other studies reported numbers of qualified researchers not reaching critical mass, inadequate research infrastructure, and inconsistent and limited funding opportunities as factors that hampered research in developing countries.

    “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.”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [64] Whitworth JA, Kokwaro G, Kinyanjui S, et al. Strengthening capacity for health research in Africa. Lancet. 2008;372:1590–3. source

      Not checked in the free run.

    • cites [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.

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Local investigator-initiated trials are more likely to influence policy and sustainably link research to action.

    “Besides, they are more likely to influence policy and sustainably link research to action [78].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [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

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S4 (based).

    Study design and conductnone given

    Most developing countries were hardly represented in the literature.

    “It is obvious that most of the developing countries were hardly represented in the literature.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Other studies reported lengthy or ill-defined approval processes, significant bureaucracy, and lack of regulatory staff with expertise in reviewing.

    “Other studies also reported lengthy or ill-defined approval processes, significant bureaucracy, and lack of regulatory staff with expertise in reviewing [66, 67].”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [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 in the free run.

    • cites [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

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    European experience showed that over-management and over-regulation might negatively affect research and that it is important to harmonize and not overregulate clinical research.

    “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].”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [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 in the free run.

    • cites [69] Sullivan R. The good, the bad, and the ugly: effect of regulations on cancer research. Lancet Oncol. 2008;9:2–3. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable).

    Interpretationnone given

    The rigorous compilation of stakeholder views and experiences lays the foundation to guide future studies.

    “However, we believe the rigorous compilation of stakeholder view and experiences lays the foundation to guide future studies.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S4 (based).

    Interpretationnone given

    Concerns may be different for foreign-led versus local investigator-initiated trials.

    “Similarly, concerns may be different for foreign led versus local investigator initiated trials.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable).

    Interpretationreasoning

    Barriers may vary widely depending on the context in which clinical trials are conducted.

    “Barriers may vary widely depending on the context in which the clinical trials are conducted.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductnone given

    Most included studies were qualitative studies with small sample size and narrow diversity of participants.

    “Most of the included studies were qualitative studies with small sample size and narrow diversity of participants.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationreasoning

    Because of inter-country differences in culture, socioeconomic and political contexts, the review's findings may not reflect the situation in any specific country.

    “There are several inter-country differences in culture, socioeconomic and political contexts, therefore our findings may not reflect the situation in any specific country.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: There are several inter-country differences in culture, socioeconomic and political contexts.

  • Classified as probably not a substantial claim.

    Study design and conductreasoning

    The review excluded papers not written in English because translation cost was not feasible.

    “We excluded papers which were not written in English. This is because the cost of translation was not feasible.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductown data

    Because of the limited number of articles in the review, the analysis did not examine similarities and differences between barriers among different developing countries.

    “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.”
    Quote in the paperSubstantial claim
66 of 66

  • 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.”
8 of 8

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?

  • Biobanking and repository research are being scrutinized and restricted more harshly.

    “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]

  • One regulatory obstacle in creating DMTs for AD is insufficient knowledge and ability of regional regulatory organizations, in addition to post-study medication administration and sustained treatment supply.

    “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]

  • There are several review levels with conflicting results and different guidelines for participant reimbursement for trial-related injuries.

    “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.

  • The same article has conflicting reference details

    Minor

    References 9 and 58 have the same title, PMID and PMC identifier, but give different article numbers and DOIs.

1 of 1

Cites

Flagged first, then by citations

2 of the 80 references couldn’t be matched to a known paper.

Research works printed but not linked: 3

  1. United Nations. World population prospect. 2015.
  2. Sulthan N. Perception of clinical research among clinical investigators in Saudi Arabia. Asian J. Pharm. Clin. Res. 2015;8:243–6.
  3. Jain R, Stern D. Effective utilisation of India for global clinical trials. J. Clin. Stud. 2011;3:30–64.

Cited by

Sorted by citations

Related

Authors
Alemayehu, C., Mitchell, G., & Nikles, J.
Affiliations
The University of Queensland (AU)
Corresponding author
Alemayehu, Chalachew
ORCID
Venue
International Journal for Equity in Health
Publisher
Springer Science and Business Media LLC
Published
2018-03-22
Volume
17
Issue
1
Pages
37-37
ISSN
1475-9276 (ISSN-L)
DOI
10.1186/s12939-018-0748-6
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
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.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-10.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-10.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

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