Clinical Trials in Developing Countries: Issues and Concerns
Year: 2012
Type: preprint
Abstract: In recent years, the increasingly global nature of health research, and in particular the conduct of clinical trials in the developing countries involving human subjects, has highlighted a number of ethical issues. Some of these issues have begun to take the center stage because of the concern that research conducted by scientists from more prosperous countries in poorer countries that are more heavily burdened by diseases may, at times, be seen as imposing ethically inappropriate burdens on the host countries and on those who participate in research trials. Less stringent ethical review, lower risk of litigation, less requirements for informed consent, and the availability of ‘treatment-naive’ patients who are much less likely to have been previously exposed to drugs or trials make research in the developing world more attractive for pharmaceutical industries. India accounts for some 15% of worldwide clinical drug studies where costs are low and regulations less strict than in the US and Europe. This marks a titanic shift of drug trials in this country. This paper critically examines the complexity of modern-day trials in which a host of regulatory and ethical issues are involved.
Source: SSRN Electronic Journal
Author: Subhash Singh
Institution: Mahatma Gandhi Kashi Vidyapith
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2244377512