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.
Booth CM, Mackillop WJ. Translating New Medical Therapies Into Societal BenefitThe Role of Population-Based Outcome Studies. JAMA. 2008;300(18):2177–2179. doi:10.1001/jama.300.18.2177
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