Christine Radawski1, Elaine Morrato2, Kenneth Hornbuckle1, Priya Bahri3, Meredith Smith4, Juhaeri Juhaeri5, Peter Mol6, Bennett Levitan7, Han-Yao Huang8, Paul Coplan9,10, Hu Li1. 1. Eli Lilly and Company, Indianapolis, IN, USA. 2. Colorado School of Public Health, University of Colorado Denver, Denver, CO, USA. 3. European Medicines Agency, London, UK. 4. Amgen, Inc., Thousand Oaks, CA, USA. 5. Pharmacoepidemiology, Sanofi, Bridgewater, NJ, USA. 6. Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. 7. Janssen Research & Development, LLC, Titusville, NJ, USA. 8. Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb, Pennington, NJ, USA. 9. Risk Management and Epidemiology, Purdue Pharma L.P., Stamford, CT, USA. 10. Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Abstract
PURPOSE: Optimizing a therapeutic product's benefit-risk profile is an on-going process throughout the product's life cycle. Different, yet related, benefit-risk assessment strategies and frameworks are being developed by various regulatory agencies, industry groups, and stakeholders. This paper summarizes current best practices and discusses the role of the pharmacoepidemiologist in these activities, taking a life-cycle approach to integrated Benefit-Risk Assessment, Communication, and Evaluation (BRACE). METHODS: A review of the medical and regulatory literature was performed for the following steps involved in therapeutic benefit-risk optimization: benefit-risk evidence generation; data integration and analysis; decision making; regulatory and policy decision making; benefit-risk communication and risk minimization; and evaluation. Feedback from International Society for Pharmacoepidemiology members was solicited on the role of the pharmacoepidemiologist. The case example of natalizumab is provided to illustrate the cyclic nature of the benefit-risk optimization process. RESULTS: No single, globally adopted benefit-risk assessment process exists. The BRACE heuristic offers a way to clarify research needs and to promote best practices in a cyclic and integrated manner and highlight the critical importance of cross-disciplinary input. Its approach focuses on the integration of BRACE activities for risk minimization and optimization of the benefit-risk profile. CONCLUSION: The activities defined in the BRACE heuristic contribute to the optimization of the benefit-risk profile of therapeutic products in the clinical world at both the patient and population health level. With interdisciplinary collaboration, pharmacoepidemiologists are well suited for bringing in methodology expertise, relevant research, and public health perspectives into the BRACE process.
PURPOSE: Optimizing a therapeutic product's benefit-risk profile is an on-going process throughout the product's life cycle. Different, yet related, benefit-risk assessment strategies and frameworks are being developed by various regulatory agencies, industry groups, and stakeholders. This paper summarizes current best practices and discusses the role of the pharmacoepidemiologist in these activities, taking a life-cycle approach to integrated Benefit-Risk Assessment, Communication, and Evaluation (BRACE). METHODS: A review of the medical and regulatory literature was performed for the following steps involved in therapeutic benefit-risk optimization: benefit-risk evidence generation; data integration and analysis; decision making; regulatory and policy decision making; benefit-risk communication and risk minimization; and evaluation. Feedback from International Society for Pharmacoepidemiology members was solicited on the role of the pharmacoepidemiologist. The case example of natalizumab is provided to illustrate the cyclic nature of the benefit-risk optimization process. RESULTS: No single, globally adopted benefit-risk assessment process exists. The BRACE heuristic offers a way to clarify research needs and to promote best practices in a cyclic and integrated manner and highlight the critical importance of cross-disciplinary input. Its approach focuses on the integration of BRACE activities for risk minimization and optimization of the benefit-risk profile. CONCLUSION: The activities defined in the BRACE heuristic contribute to the optimization of the benefit-risk profile of therapeutic products in the clinical world at both the patient and population health level. With interdisciplinary collaboration, pharmacoepidemiologists are well suited for bringing in methodology expertise, relevant research, and public health perspectives into the BRACE process.
Authors: Priya Bahri; Alexander N Dodoo; Brian D Edwards; I Ralph Edwards; Irene Fermont; Ulrich Hagemann; Kenneth Hartigan-Go; Bruce Hugman; Peter G Mol Journal: Drug Saf Date: 2015-07 Impact factor: 5.606
Authors: Giampiero Mazzaglia; Sabine M J Straus; Peter Arlett; Daniela da Silva; Heidi Janssen; June Raine; Enrica Alteri Journal: Drug Saf Date: 2018-02 Impact factor: 5.606
Authors: Meredith Y Smith; Andrea Russell; Priya Bahri; Peter G M Mol; Sarah Frise; Emily Freeman; Elaine H Morrato Journal: Drug Saf Date: 2018-04 Impact factor: 5.606