Clinical Trials
CSER organized Krishna Raj Memorial Seminar on Contemporary Issues in Health and Social Sciences in collaboration with the Indian Journal of Medical Ethics on the topic of Clinical Trials and Healthcare Regulation in India. It was held in January of 2009.
It brought together a range of different perspectives on the social, political, ethical and legal problems related to the conduct of clinical trials in India. The seminar raised several important issues. The economic vulnerability of participants was highlighted as participation in trials is often the only way to obtain treatment. Conversely, because of the sharp disparity and lack of access to care in India, there is a pool of ‘treatment naïve’ patients who are sought to be recruited in trials. Moreover, the kinds of drugs being tested are often irrelevant or unaffordable to the Indian public. The role of all levels of regulators, ranging from ethics committees to the drug comptroller general of India was discussed. There were also very heated debates on the role of the investigators (who were also, in most cases, the attending physicians) and their duty towards their participants/patients.
PowerPoint Presentations for all speakers are available. A report on the seminar will be available on the website soon.