Objective

Quantitative benefit risk assessment (qBRA) is a process that follows a quantitative framework to compare the benefit-risk profile of a medical product and other option(s), using elicited benefit-risk tradeoff preference as an input, and producing outputs in metrics that are relevant to benefit-risk assessment of the medical product.

This task force will provide practical guidance for the design, conduct and reporting of quantitative benefit-risk analyses (qBRA).  This includes:

  • defining the formal qBRA process
  • providing emerging good practices on the implementation of each step of the qBRA
  • describing how the results should be interpreted in a unified qBRA framework
  • describing how the qBRA process and results should be reported for scientific and regulatory audiences.

Rationale

Regulatory agencies are now actively encouraging and using qBRA for marketing authorization of drugs and devices. European Medicines Agency (EMA) is currently involved in the public-private Innovative Medicines Initiative (IMI) research consortium. The Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle Project (PREFER) under IMI is an important area in EMA’s regulatory strategy to 2025. In the US, FDA has committed under PDUFA VI to enhance their use of BRA in regulatory decision making across medical products, including drugs, biologics and medical devices. Despite all the recent regulatory interest in qBRA, there is little existing guidance to help researchers conduct a scientifically rigorous qBRA.

Co-Chairs

Martin Ho

Martin Ho, MS, BS, PhD

Associate Director, CBER / OBE, Food and Drug Administration
Silver Spring, MD, United States
Tommi Tervonen

Tommi Tervonen, PhD

Director of Patient Preferences, Evidera
London, LON, United Kingdom

Leadership Group

Conny Berlin

Global Head of Quantitative Safety & Epidemiology, Novartis Pharma AG
Basel, Switzerland

Bennett Levitan, PhD, MD

Senior Director, Epidemiology, Janssen Research & Development
Titusville, NJ, United States

Kevin Marsh, PhD, BA, MA

Executive Director, Patient-Centered Research, Evidera Ltd
London, LON, United Kingdom

Katherine Payne, MSc, PhD

Professor of Health Economics, The University of Manchester
Manchester, United Kingdom

Francesco Pignatti, PhD

Head of Oncology and Haematology, Human Medicines Evaluation Division, European Medicines Agency
Amsterdam, Netherlands

Praveen Thokala, PhD, MASc

Senior Research Fellow, ScHARR, The University of Sheffield
Sheffield, United Kingdom

Jorien Veldwijk, MSc, BSc

Assistant Professor, Erasmus University & Uppsala University
Rotterdam, Netherlands

Rick Vreman, MSc, PharmD

Researcher, National Health Care Institute (ZIN) / Utrecht University
Utrecht, Netherlands
Anne Cohn Donnelly, DPH
Member of Patient Council of the Michael J. Fox Foundation for Parkinson’s Research
New York, NY, USA
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