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Editorial
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Volume 359:1400-1402 September 25, 2008 Number 13
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Identifying and Addressing Safety Signals in Clinical Trials
Thomas R. Fleming, Ph.D.

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Interventions for the prevention or treatment of disease that are based on our understanding of the pathobiologic features of the illness can provide benefit in how a patient feels or functions or in whether the patient survives. Such benefits are generally achieved through on-target biologic effects of the intervention. However, there are numerous recent cases in which it has been established or strongly suggested that off-target effects of such interventions have adversely altered their risk–benefit profile. For example, in patients with rheumatoid arthritis or osteoarthritis, the cyclooxygenase-2 (COX-2) inhibitors provide an analgesic benefit with a reduced risk of gastrointestinal side . . . [Full Text of this Article]


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From the Department of Biostatistics, University of Washington, Seattle.

This article (10.1056/NEJMe0807372) was published at www.nejm.org on September 3, 2008.


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