Identifying and Addressing Safety Signals in Clinical Trials

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Abstract
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 . . .