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Volume 356:328-330 January 25, 2007 Number 4
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NSAID Trials and the Choice of Comparators — Questions of Public Health Importance
Bruce M. Psaty, M.D., Ph.D., and Noel S. Weiss, M.D., Dr.P.H.

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Under ideal conditions, large clinical trials would be designed so that they satisfied the marketing needs of the pharmaceutical manufacturers that generally sponsor them and, at the same time, answered important clinical questions that may have a major influence on public health. In practice, however, alternative choices in trial design often favor one of these two goals. The choice of the reference treatment in active-comparator studies is an excellent example.

For nonsteroidal antiinflammatory drugs (NSAIDs), which all relieve arthritis pain, the question of greatest interest in randomized trials involves the incidence of adverse events. The more selective cyclooxygenase-2 (COX-2) inhibitors . . . [Full Text of this Article]


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Dr. Psaty is a professor and codirector of the Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology, and Health Services, University of Washington, and the Center for Health Studies, Group Health, Seattle; and Dr. Weiss is a professor in the Department of Epidemiology, University of Washington, Seattle.

An interview with Robert Califf, vice chancellor for clinical research at Duke University, can be heard at www.nejm.org.


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