Monitoring and ensuring safety during clinical research

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 prot ecting human subjects that were developed when clinical research was genera lly carried out on a small scale at single institutions. To address concern s 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 tria ls are monitored, focusing on adverse event reporting and the processes by which various parties with oversight responsibilities interact in the cours e 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 moni toring committees in using aggregate data from these reports, outline the p roblems that now exist for institutional review boards as they are faced wi th multiple adverse event reports from clinical trials while conducting con tinuing review, and offer recommendations for improving the current approac h.