Translating New Medical Therapies Into Societal Benefit
- 12 November 2008
- journal article
- editorial
- Published by American Medical Association (AMA)
- Vol. 300 (18), 2177-2179
- https://doi.org/10.1001/jama.300.18.2177
Abstract
Phase 4 studies have traditionally monitored safety of new drugs and occasionally served as marketing tools for pharmaceutical companies. In the 1990s these “seeding studies” came under criticism for the substantial influence industry had on study design and interpretation.1,2 Recently, innovative study designs and access to large electronic databases have allowed investigators to evaluate outcomes in the general population and provide information regarding uptake, safety, and outcomes in the real world.3 These population-based outcome studies may have important potential roles in clinical research. In this Commentary, we describe several examples that demonstrate the emerging roles of these studies and propose that they could be considered as adjuncts to and occasionally as substitutes for randomized controlled trials.Keywords
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