Literature DB >> 23061776

Good decision making requires good communication.

Baruch Fischhoff1.   

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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Year:  2012        PMID: 23061776     DOI: 10.1007/bf03261986

Source DB:  PubMed          Journal:  Drug Saf        ISSN: 0114-5916            Impact factor:   5.606


  18 in total

Review 1.  The case for motivated reasoning.

Authors:  Z Kunda
Journal:  Psychol Bull       Date:  1990-11       Impact factor: 17.737

2.  Regulatory challenges, reimbursement, and risk-benefit assessment.

Authors:  A Breckenridge
Journal:  Clin Pharmacol Ther       Date:  2010-08       Impact factor: 6.875

3.  Weighing risks and benefits of liraglutide--the FDA's review of a new antidiabetic therapy.

Authors:  Mary Parks; Curtis Rosebraugh
Journal:  N Engl J Med       Date:  2010-02-17       Impact factor: 91.245

4.  Application of the BRAT framework to case studies: observations and insights.

Authors:  B S Levitan; E B Andrews; A Gilsenan; J Ferguson; R A Noel; P M Coplan; F Mussen
Journal:  Clin Pharmacol Ther       Date:  2010-12-22       Impact factor: 6.875

5.  Improving communication of uncertainty in the reports of the intergovernmental panel on climate change.

Authors:  David V Budescu; Stephen Broomell; Han-Hui Por
Journal:  Psychol Sci       Date:  2009-01-30

6.  Expert judgments of pandemic influenza risks.

Authors:  W Bruine De Bruin; B Fischhoff; L Brilliant; D Caruso
Journal:  Glob Public Health       Date:  2006

7.  Is quantitative benefit-risk modelling of drugs desirable or possible?

Authors: 
Journal:  Drug Discov Today Technol       Date:  2011

Review 8.  Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma.

Authors:  Hans-Georg Eichler; Francesco Pignatti; Bruno Flamion; Hubert Leufkens; Alasdair Breckenridge
Journal:  Nat Rev Drug Discov       Date:  2008-09-12       Impact factor: 84.694

9.  A multiattribute model for evaluating the benefit-risk profiles of treatment alternatives.

Authors:  James C Felli; Rebecca A Noel; Patrizia A Cavazzoni
Journal:  Med Decis Making       Date:  2008-09-23       Impact factor: 2.583

10.  Bias modelling in evidence synthesis.

Authors:  Rebecca M Turner; David J Spiegelhalter; Gordon C S Smith; Simon G Thompson
Journal:  J R Stat Soc Ser A Stat Soc       Date:  2009-01       Impact factor: 2.483

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  4 in total

1.  The ISoP CommSIG for Improving Medicinal Product Risk Communication: A New Special Interest Group of the International Society of Pharmacovigilance.

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

2.  Assessing the Benefit-Risk Profile for Pediatric Implantable Auditory Prostheses.

Authors:  Laurel M Fisher; Amy S Martinez; Frances J Richmond; Mark D Krieger; Eric P Wilkinson; Laurie S Eisenberg
Journal:  Ther Innov Regul Sci       Date:  2017-11-29       Impact factor: 1.778

3.  Focusing on risk communication about medicines: why now?

Authors:  Priya Bahri; Mira Harrison-Woolrych
Journal:  Drug Saf       Date:  2012-11-01       Impact factor: 5.606

4.  The Saudi Arabia Food and Drug Authority: An Evaluation of the Registration Process and Good Review Practices in Saudi Arabia in Comparison with Australia, Canada and Singapore.

Authors:  Hajed Hashan; Ibrahim Aljuffali; Prisha Patel; Stuart Walker
Journal:  Pharmaceut Med       Date:  2015-11-06
  4 in total

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