Misleading report on clinical trials in India

Clinical Trials in Developing Countries

“…Strong concern has been expressed in the lay press that these figures for trial-related deaths are underestimates (Srinivasan, 2013). Ethical concerns were strongly expressed not only in the lay press (Datta, 2013) but also in medical journals with worldwide coverage (Sugarman et al, 2013;Yee, 2012), although specific allegations were robustly refuted by site investigators (Pauranik et al, 2012).…”

Challenges in launching multinational oncology clinical trials in India

“…There is no restriction in the ICMR guidelines on principal investigators also being members of ECs, [34] and this could potentially lead to conflicts of interest. A survey covering 20 ECs in India revealed deficiencies in composition, quorum, and review of insurance documents and clinical trial agreements, reinforcing the need for providing specific training to EC members.…”