Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products Workshop Summary (2014) / Chapter Skim
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1 Introduction
1 Introduction
Pages 1-8
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is developing an enhanced structured approach to benefit–risk assessments2 in drug regulatory decision making 1 The planning committee's role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants, and are not necessarily endorsed or verified by the Forum or the Institute of Medicine, and they should not be construed as reflecting any group consensus.
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Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. The FDA PDUFA V Plan suggests that FDA's enhanced structured approach is intended to serve as a template for product reviews and a vehicle to explain the basis of regulatory decisions.4 Box 1-1 provides additional information on the two areas of uncertainty suggested in the FDA PDUFA V Plan as deserving additional attention.
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The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Baruch Fischhoff, Howard Heinz University Professor, Department of Social and Decision Sciences, Department of Engineering BOX 1-2 Statement of Task for the Workshops An ad hoc planning committee will plan two 1-day public workshops that will address the need to advance the development of more systematic and structured approaches to characterize and communicate: (a)
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Chapter 5 highlights principles of effective risk communication and potential opportunities to improve the utility of current communication tools and approaches for conveying benefits, risks, and uncertainties to a broad audience, in part through a case study of Tysabri. Chapter 6 concludes this summary of the workshop with views expressed by individual participants during the final workshop session about potential opportunities to move forward in developing approaches for characterizing and communicating uncertainty in the assessments of benefits and risks of pharmaceutical products.
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Several academic disciplines already employ effective approaches to characterizing uncertainty and for supporting decisions made under conditions of uncertainty. Frey noted that adapting existing scientific methods for characterizing and assessing uncertainties can lend additional 6 This section is based on presentations by Janet Woodcock, Director, CDER, FDA, and Patrick J
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The nature of the clinical trial process itself, which is focused C on efficacy in a tightly controlled participant population, can give rise to uncertainty. For example, the relatively short duration of a clinical trial leads to uncertainty about long-term effects when the drug will be used chroni cally in the intended patient population.
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Color coded areas of the table under the category of "Evidence and Uncertainties" are informed by FDA's Patient Figure 1-1 Focused Drug Development initiative and these IOM workshops, respectively. NOTE: For more information on FDA's benefit–risk framework, see the FDA PDUFA V Plan at: http://www.fda.gov/downloads/forindustry/userfees/ prescriptiondruguserfee/ucm329758.pdf (accessed September 12, 2014)
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• nce provided information on the benefits and risks of a product, and what O is uncertain, unknown, or still being studied, individuals can make informed decisions about their willingness to accept the trade-offs of a treatment based on their unique risk tolerance and personal values. a This box is based on presentations by Baruch Fischhoff, Howard Heinz University Profes sor, Department of Social and Decision Sciences, Department of Engineering and Public Policy, Carnegie Mellon University, and Robert E
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