Conduct of clinical trials in developing countries: a perspective.
OBJECTIVE
To provide a broad perspective of contextual factors involved in the conduct of clinical trials in developing countries.


RESULTS
The quantity of research in developing countries continues to be inadequate, with clinical trials comprising a small fraction of the total research output. Most trials done in developing countries tend to be designed in developed countries and led by investigators in those nations. The main challenges in the conduct of trials in developing countries stem from the vulnerability of the populations due to illiteracy, poverty, limited research infrastructure, lack of sufficient numbers of experienced investigators and trained support personnel, and fragmented healthcare system.


CONCLUSIONS
There is a need to formulate and conduct trials to test treatments that are context-specific and socially relevant. With careful planning in advance and shared partnership among sponsors, host-country research practitioners, government agencies and the community, many of the challenges facing clinical trial research can be overcome over the medium to long term. This would enable conformity to contemporary guidelines in both letter and spirit and hopefully develop research questions addressing the needs of developing countries.
Devasenapathy
Niveditha
N
Centre for Chronic Disease Control (CCDC), New Delhi, India.
Singh
Kavita
K
Prabhakaran
Dorairaj
D
D002986:Clinical Trials as Topic / Q000379:methods*; D003906:Developing Countries; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent; D012106:Research