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.
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.
Morse MA, Califf RM, Sugarman J. Monitoring and Ensuring Safety During Clinical Research. JAMA. 2001;285(9):1201–1205. doi:10.1001/jama.285.9.1201
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