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Measuring benefit and balancing risk: strategies for the benefit–risk assessment of new medicines in a risk-averse environment

Walker, S., McAuslane, N., Liberti, L. and Salek, Mir-saeed 2009. Measuring benefit and balancing risk: strategies for the benefit–risk assessment of new medicines in a risk-averse environment. Clinical Pharmacology and Therapeutics 85 (3) , pp. 241-246. 10.1038/clpt.2008.277

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Abstract

Over the past 5 years, the environment for developing new medicines has become increasingly “risk averse.” The media, the public, and policy makers tend to focus more on the risk profile of new and marketed medicines than on their benefits. The CMR International Institute for Regulatory Science Workshop on Measuring Benefit and Balancing Risk, held in Washington, DC, in June 2008, sought ways to encourage an environment in which a more balanced view of risks and benefits could be formed. Important progress has been made in the methodology used to assess BR in the development and review of new medicines, but there is a great deal yet to be achieved. The workshop’s participants looked at practical aspects of developing a structured framework for evaluating benefits and risks and discussed the ways in which pharmaceutical companies and regulatory agencies are working to move the science forward. The meeting brought together experts from regulatory agencies, pharmaceutical companies, and academia for constructive discussion on how companies and agencies are approaching their development of a BR assessment framework and the implications of understanding both pre- and postmarketing benefits and risks. The Appendix contains a list of participants. The goal of developing a common BR assessment is shared by many parties: pharmaceutical companies, regulators, health-care providers, patient and support networks, and professional organizations—all with the objective of developing therapies with BR balances acceptable to the stakeholders. Recent regulatory initiatives—including the US Food and Drug Administration (FDA) Premarket Risk Assessment Guidance for Industry,1 the framework for risk evaluation and mitigation strategy as required under the Food and Drug Administration Amendments Act of 2007 (ref. 2), and the Report of the CHMP [Committee for Medicinal Products for Human Use] Working Group on Benefit–Risk Assessment Models and Methods3—are important steps toward the establishment of standardized approaches to this activity. These build on recognized examples of BR assessment strategies based on models used for individual clinical trials and more general models with broad applicability to BR assessment. The CMR Institute first looked specifically at methodology for BR assessment and at the communication of risk at two workshops in 2002, and the 2008 workshop revisited both these themes. In the intervening years, the institute has initiated a specific study and held special-focus workshops to look at multicriteria decision analysis as one of the models that can be applied to BR assessment.4 Primary objectives of the 2008 workshop were to discuss whether a global framework for BR assessment is achievable and to examine the opportunities for and barriers to the development and implementation of a common framework.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Pharmacy
Publisher: Elsevier
ISSN: 0009-9236
Last Modified: 14 Dec 2022 03:07
URI: https://orca.cardiff.ac.uk/id/eprint/61036

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