Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
10514542 | Journal of Clinical Epidemiology | 2005 | 6 Pages |
Abstract
The recent withdrawal from the market of rofecoxib took years; the approach proposed here could shorten this time. It is important to revisit the comprehensiveness of the ability to detect important outcomes. Composite outcomes can be more varied in content, including mortality and morbidity. The proposed basket would consist of predefined designated endpoints in each organ system that could be associated with the population one is treating, and not just expected to be related to treatment. The goal is to anticipate and have a reasonable chance of detecting the unexpected side effect.
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Authors
Peter Tugwell, Maria G. Judd, Jim F. Fries, Gurkirpal Singh, George A. Wells,