Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research

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DIANE Publishing, 2008 - 6 pages
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Evaluates the Dept. of Health and Human Services┐ oversight of sponsor and investigator efforts to recruit human subjects for industry-sponsored clinical trials (CT). It focuses on industry-sponsored CT because in recent years industry sponsors have assumed a more prominent role in the search for new drugs. Sponsors and investigators are facing increasing difficulty finding enough subjects in a timely manner to bring drugs to market within their desired time-frame. This report explains the recruitment practices used in industry-sponsored CT for investigational drugs; identifies major concerns about them; and addresses the extent and type of oversight undertaken by institutional review boards and, the FDA, and the NIH.

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