Science. 2013 Nov 29;342(6162):1042. doi: 10.1126/science.342.6162.1042-b.
In his News & Snalysis story “Clinical trials paused as India adopts new rules” (26 July, p. 327), Y. Bhattacharjee discusses the new regulations put in place to protect clinical trial participants. Ethics committees responsible for approving clinical trial protocols play a key role in participant safety. It should be deemed unethical to enroll patients in a clinical trial that has a low probability of generating meaningful information, no matter how promising a new investigational therapy. Thus, the ethics committee should always critically evaluate clinical trial protocols for their probability of success.
To make sure these evaluations occur, ethics committees should include or consult qualified statisticians. Ethics committees should ensure that clinical study protocols are adequately powered to succeed and that the underlying assumptions used in power calculations are reasonable. Only then should clinical trials be allowed to proceed in India, or the rest of the world.
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