Recommendations for benefit-risk assessment methodologies and visual representations

Pharmacoepidemiology and Drug Safety
Diana HughesPROTECT Benefit-Risk group

Abstract

The purpose of this study is to draw on the practical experience from the PROTECT BR case studies and make recommendations regarding the application of a number of methodologies and visual representations for benefit-risk assessment. Eight case studies based on the benefit-risk balance of real medicines were used to test various methodologies that had been identified from the literature as having potential applications in benefit-risk assessment. Recommendations were drawn up based on the results of the case studies. A general pathway through the case studies was evident, with various classes of methodologies having roles to play at different stages. Descriptive and quantitative frameworks were widely used throughout to structure problems, with other methods such as metrics, estimation techniques and elicitation techniques providing ways to incorporate technical or numerical data from various sources. Similarly, tree diagrams and effects tables were universally adopted, with other visualisations available to suit specific methodologies or tasks as required. Every assessment was found to follow five broad stages: (i) Planning, (ii) Evidence gathering and data preparation, (iii) Analysis, (iv) Exploration and (v) Conclusion and d...Continue Reading

References

Jan 1, 1989·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·A GoldhirschA S Coates
Jun 30, 1988·The New England Journal of Medicine·A LaupacisR S Roberts
Sep 5, 2001·Quality in Health Care : QHC·M RyanA Ludbrook
Jul 16, 2002·Journal of Epidemiology and Community Health·J AttiaA J Dobson
Jul 16, 2002·Journal of Epidemiology and Community Health·R F HellerJ Page
Sep 5, 2002·Statistics in Medicine·Thomas Lumley
Oct 16, 2003·Pharmacoepidemiology and Drug Safety·William L HoldenWanju Dai
Nov 15, 2003·BMJ : British Medical Journal·Richard F HellerSelwyn St Leger
Feb 14, 2004·BMJ : British Medical Journal·Cosetta MinelliNicola J Cooper
Sep 28, 2004·Statistics in Medicine·G Lu, A E Ades
Jan 15, 2005·Journal of Clinical Epidemiology·Alexander J SuttonDavid R Jones
Aug 1, 2006·Health Policy and Planning·Franco Sassi
May 9, 2007·Health Affairs·Louis P GarrisonBrian W Bresnahan
Feb 12, 2008·International Journal of Epidemiology·T P van StaaH G M Leufkens
Sep 12, 2009·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Larry D LyndA Brett Hauber
Dec 24, 2010·Clinical Pharmacology and Therapeutics·B S LevitanF Mussen
Jan 27, 2011·Statistics in Medicine·Tommi TervonenDouwe Postmus
Apr 13, 2011·Journal of Public Health·Arpana VermaRichard F Heller
May 14, 2014·Pharmacoepidemiology and Drug Safety·Shahrul Mt-IsaUNKNOWN IMI-PROTECT benefit-risk participants
Nov 3, 2015·Pharmacoepidemiology and Drug Safety·Christine E HallgreenUNKNOWN PROTECT Benefit-Risk group

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Citations

Jan 27, 2015·Biometrical Journal. Biometrische Zeitschrift·Richard NixonAndrew Thomson
Jan 30, 2015·Biometrical Journal. Biometrische Zeitschrift·Ed WaddinghamDeborah Ashby
Feb 22, 2017·Pharmacoepidemiology and Drug Safety·Xavier Kurz
Apr 1, 2019·Clinical Pharmacology and Therapeutics·Tommi TervonenLawrence D Phillips
Jun 13, 2020·British Journal of Clinical Pharmacology·Aris Angelis, Lawrence D Phillips
Jul 1, 2017·Therapeutic Innovation & Regulatory Science·Meredith Y SmithQi Jiang
Jul 22, 2018·Statistical Methods in Medical Research·Gaelle Saint-HilaryPavel Mozgunov
Feb 26, 2020·Journal of Biopharmaceutical Statistics·Dongyan YanRam Tiwari
Sep 13, 2020·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Hugo ArleguiNicolas Praet
Apr 22, 2019·The European Journal of Health Economics : HEPAC : Health Economics in Prevention and Care·Mónica D OliveiraPanos Kanavos
Jan 27, 2019·Current Medical Research and Opinion·Christos ChouaidPhilippe Devillier
Sep 12, 2020·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Hugo ArleguiNicolas Praet
Aug 28, 2020·Medical Decision Making : an International Journal of the Society for Medical Decision Making·Aris AngelisPanos Kanavos
Sep 7, 2019·Therapeutic Advances in Drug Safety·Juhaeri Juhaeri
Dec 1, 2020·International Journal of Clinical Practice·Ian MilsomChristopher Chapple
Oct 29, 2020·Therapeutic Innovation & Regulatory Science·Meredith Y SmithKevin Marsh
Dec 22, 2020·Therapeutic Advances in Drug Safety·Marie-Laure KürzingerStéphanie Tcherny-Lessenot
May 12, 2020·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Hélène E AschmannMilo A Puhan

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