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Clinical Research Under Scrutiny

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National Institutes of Health (NIH) Director Elias Zerhouni, MD, has highlighted the need to improve the nation's clinical research system. He suggests that this goal can be attained by re-engineering existing policies and procedures to establish uniformity in regulation and in human subjects' protection. He has expressed the need to develop standards governing the organization of trials, in part to allow for cross-study comparisons, as well as new approaches to privacy issues. During presentations to industry and government groups, Zerhouni stated that improving the clinical research process will require a systems approach, involving relationships with patient advocacy groups, the public, academic health centers, and community physicians. Dr. Zerhouni has identified specific issues of concern with the system, including the inability to translate research into practice, fragmentation of research, no clinical data infrastructure, and a declining supply of academic physicians.

The NIH discussion comes at an opportune time. According to a report released in October 2002 by the Institute of Medicine (IOM) of the National Academies, broader federal oversight is needed to ensure that the health and well-being of people enrolled in clinical research studies, whether publicly or privately funded, …

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