Abstract
Benefit-risk (B-R) assessments inform decisions regarding drug development and lifecycle management, serve as a basis for regulatory determinations, and help clinicians, patients, and payers make rational, value-based treatment decisions. Nevertheless, no widely accepted, systematic methods exist to guide, justify, and communicate benefit-risk decisions in a transparent and consistent manner. The B-R Action Team (BRAT), formed by the Pharmaceutical Research and Manufacturers of America (PhRMA), has developed a structured approach to B-R assessment—the “BRAT Framework”—that assists decision makers in selecting, organizing, summarizing, and communicating evidence relevant to B-R decisions. The BRAT Framework’s functionality has been demonstrated previously in a series of scenarios with hypothetical drugs as well as in a few real-world applications. Here we report results of a pilot program to assess the value of the Framework in pharmaceutical development and postmarketing settings, for the purpose of informing PhRMA’s regulatory advocacy. A third-party consultant conducted the assessment through a survey of pharmaceutical companies’ experiences using the Framework. We also identify aspects of the Framework that require further development.
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