Under ideal conditions, large clinical trials would be designedso that they satisfied the marketing needs of the pharmaceuticalmanufacturers that generally sponsor them and, at the same time,answered important clinical questions that may have a majorinfluence on public health. In practice, however, alternativechoices in trial design often favor one of these two goals.The choice of the reference treatment in active-comparator studiesis an excellent example.
For nonsteroidal antiinflammatory drugs (NSAIDs), which allrelieve arthritis pain, the question of greatest interest inrandomized 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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