Application of the Benefit-Risk Action Team (BRAT) Framework in Pharmaceutical R&D: Results From a Pilot Program
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Application of the Benefit-Risk Action Team (BRAT) Framework in Pharmaceutical R&D: Results From a Pilot Program
Drug Information Journal 46(6) 736-743 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861512458908 http://dij.sagepub.com
Rebecca Noel, MSPH, DrPH1, Richard Hermann, MD, MPH2, Bennett Levitan, MD, PhD3, Douglas J. Watson, MSPH, PhD4, and Kristin Van Goor, PhD, RAC5
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. Keywords benefit-risk, risk assessment, drug development, pharmacovigilence, outcome assessment
Introduction The determination of a drug’s potential value to patients requires the evaluation of safety and efficacy in the broader context of disease severity, unmet medical needs, and processes to mitigate drug harms (eg, Risk Evaluation and Mitigation Strategies [REMS] and Risk Management Plans [RMPs]). There is growing recognition among pharmaceutical manufacturers and the agencies that regulate the industry that a structured approach to benefit-risk (B-R) assessment would be advantageous. A widely used and accepted B-R framework, applied systematically and consistently throughout drug development and approval, used by both companies and regulators, would help lead to more efficient communication among pharmaceutical companies, regulatory agencies, and other stakeholders. In turn, the increased transparency and consistency of such a framework would result in better decision making and ultimately in improved health care for patients.1-6
Over the past several years, a number of organizations have called for or supported initiatives to develop a standardized approach to B-R assessment, including the Institute of
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Eli Lilly and Company, Indianapolis, IN, USA AstraZeneca Pharmaceuticals, Wilmington, DE, USA 3 Janssen Research & Development, LLC,
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