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By Margaret A. Hamburg


society representing 8,600 infectious diseases physicians and scientists devoted to patient care, education, research, prevention and public health, is increasingly concerned about the effects of regulatory burden on the ability to perform badlyneeded clinical research. In a recent policy statement, IDSA identified five key areas in which pragmatic actions could be taken that would decrease duplicative and ineffective regulatory burden. 1 One of these five areas directly involves the U.S. Food and Drug Administration (FDA). Specifically, IDSA proposes that one major aspect of the system for adverse event reporting from multicenter clinical trials is unnecessarily duplicative and expensive. It is critical that adverse events occurring during the course of interventional biomedical research be identified and analyzed in a timely manner. Modern clinical trials include an efficient system for adverse event reporting and analysis. Adverse events from multicenter clinical trials are reported to the sponsor’s Data Center, often over the Internet. These events can undergo initia

Year: 2009
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