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Good Decision Making Requires Good Communication

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Abstract

The methods used for regulatory decisions must facilitate three kinds of communication: (i) with individual experts who must translate their knowledge into usable form; (ii) among the experts whose pooled knowledge informs those choices; and (iii) between regulators and those affected by their choices. Decision-making methods vary in their reliance on expert judgement and computational methods and, hence, in their ability to meet the goals of sound decision making: breadth, depth, precision, neutrality, evaluability and transparency. An approach developed by the US FDA, the Benefit-Risk Framework, integrates judgement and computation, cognizant of their strengths and weaknesses. Its application both requires and facilitates good communication about risks and benefits.

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Acknowledgements

No sources of funding were used to prepare this manuscript. The author has served as Chair of the FDA Risk Communication Advisory Committee and as a consultant to the FDA. The views expressed here are his alone.

This article is part of a theme issue co-edited by Priya Bahri, European Medicines Agency, UK, and Mira Harrison-Woolrych, New Zealand Pharmacovigilance Centre, New Zealand. No external funding was used to support the publication of this theme issue.

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Authors and Affiliations

  1. Department of Social and Decision Sciences, Department of Engineering and Public Policy, Carnegie Mellon University, Pittsburgh, Pennsylvania, 15213-3890, USA

    Baruch Fischhoff (Howard Heinz University Professor)

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  1. Baruch Fischhoff
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Correspondence to Baruch Fischhoff.

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Fischhoff, B. Good Decision Making Requires Good Communication. Drug Saf 35, 983–993 (2012). https://doi.org/10.1007/BF03261986

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