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Compensation to clinical trial participants in India: A gap analysis #MMPMID28929045
Urooj M; Husain GM; Khan MA; Kazmi MH
Int J Pharm Investig 2017[Apr]; 7 (2): 41-6 PMID28929045show ga
The recent amendments notified by the Government of India, for conducting clinical trial, is greatly appreciable as promoting safety and well-being of human subjects. These rules clearly state that medical management of injuries in clinical trials is mandatory, and clinical trial-related injury or death needs to be compensated over and above the medical management. These rules need to be reconsidered for simplification and better understanding of issues regarding compensation. There is a need of clarity at some points which should be discussed with all stakeholders for better understanding of current regulations. In our view, attention must also be given to academic investigators, during discussion to promote availability of cost-effective treatment in India.