Author(s): Bindra S, Kochhar P
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Abstract INTRODUCTION: The last decade has witnessed globalization of drug development with early phase studies being increasingly placed in the developing world. Whether research related ethical principles around informed consent, adverse event (AE) reporting, post trial drug commitments and others are being observed, merits evaluation METHODS: A specially designed survey questionnaire was served to 29 investigators in India, having prior experience of participating in drug development studies with pharmaceutical companies. The survey included questions on investigator profile, study design, informed consent process, safety reporting, patient and physician compensation, post trial drug commitments among others RESULTS: Most respondents had nearly two decades of clinical experience. Majority believed that the research they conducted was relevant to the needs of society, but wanted common research goals established between the sponsors and the community. All investigators cited their expertise, reliability, patient pool, and low costs as the principal reasons for greater placement of studies. However, very few investigators felt that all their patients in studies were "truly autonomous". Most investigators indicated confidence in the adverse event reporting ability and expressed satisfaction with their Ethics Committees. A third of investigators accepted some form of conflict of interest between their role as a physician and researcher. Opinion was divided regarding satisfaction with the post trial drug commitments of the sponsor companies CONCLUSION: The survey revealed a good understanding of the ethical issues around conduct of clinical research in a developing country. The sooner ethical institutions and practices are fortified, the better it is for communities, patients, investigators and pharmaceutical sponsors.
This article was published in Perspect Clin Res
and referenced in Journal of Clinical Research & Bioethics