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Michael A. Morse, MD,MHS; Robert M. Califf, MD; Jeremy Sugarman, MD,MPH,MA

JAMA. 2001;285:1201-1205.

Increased numbers of clinical trials, many of which are large, multicenter, and sometimes international, and the marked shift of funding for clinical trials to industry have made apparent the inadequacy of mechanisms for protecting human subjects that were developed when clinical research was generally carried out on a small scale at single institutions. To address concerns regarding the protection of human subjects, a group of professionals with expertise in various aspects of clinical trials was assembled in May 2000. Participants described and evaluated the mechanisms by which clinical trials are monitored, focusing on adverse event reporting and the processes by which various parties with oversight responsibilities interact in the course of these trials. In this article, we describe the manner in which adverse event reporting might function to enhance safety and the role of data monitoring committees in using aggregate data from these reports, outline the problems that now exist for institutional review boards as they are faced with multiple adverse event reports from clinical trials while conducting continuing review, and offer recommendations for improving the current approach.

Author Affiliations: Departments of Medicine (Drs Morse, Califf, and Sugarman) and Philosophy (Dr Sugarman), The Duke Clinical Research Institute (Dr Califf), and the Center for the Study of Medical Ethics and Humanities (Dr Sugarman), Duke University, Durham, NC.

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