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Application of the Benefit-Risk Action Team (BRAT) Framework in Pharmaceutical R&D: Results From a Pilot Program

  • Benefit-Risk Assessment
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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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Authors and Affiliations

  1. Eli Lilly and Company, Indianapolis, IN, USA

    Rebecca Noel MSPH, DrPH

  2. AstraZeneca Pharmaceuticals, Wilmington, DE, USA

    Richard Hermann MD, MPH

  3. Janssen Research & Development, LLC, Titusville, NJ, USA

    Bennett Levitan MD, PhD

  4. Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA

    Douglas J. Watson MSPH, PhD

  5. Scientific & Regulatory Affairs, PhRMA, 950 F Street NW, Suite 300, Washington, DC, 20004, USA

    Kristin Van Goor PhD, RAC (Senior Director)

Authors
  1. Rebecca Noel MSPH, DrPH
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  2. Richard Hermann MD, MPH
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  3. Bennett Levitan MD, PhD
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  4. Douglas J. Watson MSPH, PhD
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  5. Kristin Van Goor PhD, RAC
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Corresponding author

Correspondence to Kristin Van Goor PhD, RAC.

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Noel, R., Hermann, R., Levitan, B. et al. Application of the Benefit-Risk Action Team (BRAT) Framework in Pharmaceutical R&D: Results From a Pilot Program. Ther Innov Regul Sci 46, 736–743 (2012). https://doi.org/10.1177/0092861512458908

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  • DOI: https://doi.org/10.1177/0092861512458908

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