Clinical-Trial Agreements between Medical Schools and Industry

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Abstract
I am a retired biostatistician with recent service on an institutional review board (IRB), and my experience supports the observations of Schulman et al. (Oct. 24 issue)1 and suggests that the implications of their findings are serious and far-reaching. Too large a proportion of the studies that I have reviewed were designed by marketing personnel at big pharmaceutical companies or by new biotechnology firms, few of which have meaningful experience with clinical trials. Protocols were poorly justified and poorly written; most studies were underpowered, too many were irrelevant, and some were dangerous. Seldom was there an opportunity for faculty input to the protocol, before or after IRB review.