Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia
Open accessAbstract
Objectives: Clinical trials provide ‘gold standard’ evidence for policy, but insufficient locally relevant trials are conducted in low-income and middle-income countries. Local investigator-initiated trials could generate highly relevant data for national governments, but information is lacking on how to facilitate them. We aimed to identify barriers and enablers to investigator-initiated trials in Ethiopia to inform and direct capacity strengthening initiatives. Design: Exploratory, qualitative study comprising of in-depth interviews (n=7) and focus group discussions (n=3). Setting: Fieldwork took place in Ethiopia during March 2011. Participants: Local health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were recruited through snowball sampling (n=20). Outcome measures: Detailed discussion notes were analysed using thematic coding analysis and key themes were identified. Results: All participants perceived investigator-initiated trials as important for generating local evidence. System and organisational barriers included: limited funding allocation, weak regulatory and administrative systems, few learning opportunities, limited human and material capacity and poor incentives for conducting research. Operational hurdles were symptomatic of these barriers. Lack of awareness, confidence and motivation to undertake trials were important individual barriers. Training, knowledge sharing and experience exchange were key enablers to trial conduct and collaboration was unanimously regarded as important for improving capacity. Conclusions: Barriers to trial conduct were found at individual, operational, organisational and system levels. These findings indicate that to increase locally led trial conduct in Ethiopia, system wide changes are needed to create a more receptive and enabling research environment. Crucially, the creation of research networks between potential trial groups could provide much needed practical collaborative support through sharing of financial and project management burdens, knowledge and resources. These findings could have important implications for capacity-strengthening initiatives but further research is needed before the results can be generalised more widely.
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Delays in regulatory and ethical review were mentioned in most articles.
“Delays in regulatory and ethical review were mentioned in most articles [40, 42, 45, 46, 48, 49, 52].”
From Barriers for conducting clinical trials in developing countries—A systematic review (2018) · cites this paper as [48]
Over-complex and unreasonably strict ethical and regulatory systems were reported in some articles.
“Over-complex and unreasonably strict ethical and regulatory systems were also reported in some articles [48, 49, 51].”
From Barriers for conducting clinical trials in developing countries—A systematic review (2018) · cites this paper as [48]
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].”
From Barriers for conducting clinical trials in developing countries—A systematic review (2018) · cites this paper as [48]
Many articles reported that lack of time and other competing priorities related to competing demands of working multiple jobs and their attendant responsibilities was an issue.
“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.”
From Barriers for conducting clinical trials in developing countries—A systematic review (2018) · cites this paper as [48]
The majority of articles stated that the administrative environment was characterized by lengthy and complex logistic and financial systems that hampered the conduct of clinical trials.
“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.”
From Barriers for conducting clinical trials in developing countries—A systematic review (2018) · cites this paper as [48]
Absence of suitable research infrastructure was stated by many articles.
“Absence of suitable research infrastructure was stated by many articles [45, 47–50].”
From Barriers for conducting clinical trials in developing countries—A systematic review (2018) · cites this paper as [48]
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- Authors
- Franzen, S. R. P., Chandler, C., Enquselassie, F., Siribaddana, S., Atashili, J., Angus, B., & Lang, T.
- Affiliations
- University of Oxford (GB)
- London School of Hygiene & Tropical Medicine (GB)
- Addis Ababa University (ET)
- Rajarata University of Sri Lanka (LK)
- University of Buea (CM)
- Corresponding author
- Franzen, Samuel R P
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2013-11
- Volume
- 3
- Issue
- 11
- Pages
- e003616
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC3845054
- OpenAlex
- W2137693318
- Cited by
- 45
- References
- 26
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 4 · 2023: 5 · 2022: 2 · 2021: 6 · 2020: 4 · 2019: 4 · 2018: 4 · 2017: 5 · 2015: 1 · 2014: 2
- FWCI
- 1.81
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ Open (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Funders
- Bill and Melinda Gates Foundation (OPP1053843)
- Topics
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health and Medical Research Impacts
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Global Health and Surgery
- Keywords
- investigator-initiated trials, barriers and facilitators, research capacity building, research funding, clinical trial regulation, research incentives, research training, research networks, low- and middle-income countries, Ethiopia
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