Literature DB >> 17632534

Current assessment of risk-benefit by regulators: is it time to introduce decision analyses?

D A Hughes1, A M Bayoumi, M Pirmohamed.   

Abstract

Regulatory risk-benefit assessments may overweight small but serious risks relative to benefits. Using terfenadine and torsade de pointes as an exemplar, we illustrate how a different decision may result when outcomes are assessed using quality-adjusted life-years within a decision-analytical framework. The adoption of common measures of health outcome and the use of decision analyses, which will allow uncertainty to be characterized and evidence to be compiled from disparate sources, may inform complex risk-benefit decisions and should be used in conjunction with qualitative assessments.

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Year:  2007        PMID： 17632534     DOI： 10.1038/sj.clpt.6100240

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


  10 in total

Review 1.  New approaches to drug safety: a pharmacovigilance tool kit.

Authors:  Lesley Wise; John Parkinson; June Raine; Alasdair Breckenridge
Journal:  Nat Rev Drug Discov       Date:  2009-09-18       Impact factor: 84.694

2.  Joint assessment of intended and unintended effects of medications: an example using vascular endothelial growth factor inhibitors for neovascular age-related macular degeneration.

Authors:  Adrian R Levy; Shelagh Szabo; Andrew Briggs; Andreas Pleil; Alison Davie; Gergana Zlateva; Jonathan Javitt
Journal:  J Ophthalmol       Date:  2010-02-16       Impact factor: 1.909

3.  A formal risk-benefit framework for genomic tests: facilitating the appropriate translation of genomics into clinical practice.

Authors:  David L Veenstra; Joshua A Roth; Louis P Garrison; Scott D Ramsey; Wylie Burke
Journal:  Genet Med       Date:  2010-11       Impact factor: 8.822

Review 4.  Critical review of cancer risk associated with angiotensin receptor blocker therapy.

Authors:  Grégoire Wuerzner; Michel Burnier; Bernard Waeber
Journal:  Vasc Health Risk Manag       Date:  2011-12-12

5.  Dabigatran etexilate versus warfarin in management of non-valvular atrial fibrillation in UK context: quantitative benefit-harm and economic analyses.

Authors:  Joshua Pink; Steven Lane; Munir Pirmohamed; Dyfrig A Hughes
Journal:  BMJ       Date:  2011-10-31

6.  A novel measure of drug benefit-risk assessment based on Scale Loss Score.

Authors:  Gaelle Saint-Hilary; Veronique Robert; Mauro Gasparini; Thomas Jaki; Pavel Mozgunov
Journal:  Stat Methods Med Res       Date:  2018-07-20       Impact factor: 3.021

7.  A comparison of various aggregation functions in multi-criteria decision analysis for drug benefit-risk assessment.

Authors:  Tom Menzies; Gaelle Saint-Hilary; Pavel Mozgunov
Journal:  Stat Methods Med Res       Date:  2022-01-19       Impact factor: 3.021

8.  Utilising benefit-risk assessments within clinical trials-a protocol for the BRAINS project.

Authors:  Nikki Totton; Steven Julious; Dyfrig Hughes; Jonathan Cook; Katie Biggs; Lizzie Coates; Andrew Cook; Catherine Hewitt; Simon Day
Journal:  Trials       Date:  2021-01-19       Impact factor: 2.279

9.  Comparative effectiveness of dabigatran, rivaroxaban, apixaban, and warfarin in the management of patients with nonvalvular atrial fibrillation.

Authors:  J Pink; M Pirmohamed; D A Hughes
Journal:  Clin Pharmacol Ther       Date:  2013-04-25       Impact factor: 6.875

10.  Patient-Focused Drug Development Methods for Benefit-Risk Assessments: A Case Study Using a Discrete Choice Experiment for Antiepileptic Drugs.

Authors:  Emily A F Holmes; Catrin Plumpton; Gus A Baker; Ann Jacoby; Adele Ring; Paula Williamson; Anthony Marson; Dyfrig A Hughes
Journal:  Clin Pharmacol Ther       Date:  2018-10-25       Impact factor: 6.875
  10 in total

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