Mussen / Salek / Walker Benefit-Risk Appraisal of Medicines

A systematic approach to decision-making
1. Auflage 2009
ISBN: 978-0-470-74812-1
Verlag: John Wiley & Sons
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 304 Seiten, E-Book

Benefit-risk assessment is at the centre of the approval processfor every new medicine. The ability to assess the risks of a newmedicine accurately and to balance these against the benefits themedicine could bring is critical for every regulatory authority andpharmaceutical company. Despite this there are very few tried andtested evaluative models currently available.
The authors of this book have developed a new, pioneering toolfor the assessment of benefits and risks for new medicines indevelopment. This model utilises a multi-criteria decision analysiswhich involves selecting, scoring and weighting key benefit andrisk attributes and leads to an overall appraisal of benefits andrisks of medicines.
Benefit-Risk Appraisal of Medicines establishes thebackground and criteria required to assess benefit and risk ingeneral and reviews the current practices by regulatory authoritiesand the pharmaceutical industry, including those models currentlyavailable. It outlines the development and evaluation of theauthors' new model and analyses the implications of itsimplementation.
* Describes an innovative, systematic model which leads totransparent and responsible benefit-risk decision making
* Contributes important ideas to the debate on benefit-riskappraisal
* Provides a future framework for benefit-risk appraisal ofmedicines
Benefit-Risk Appraisal of Medicines covers the entireprocess from the discovery of new medicines to their marketing andis ideal for all those who work in the pharmaceutical industry andregulatory authorities,, as well as post-graduate students ofpharmaceutical medicine and clinical pharmacology.

Autoren/Hrsg.

Mussen, Filip

Salek, Sam

Walker, Stuart

Inhaltsverzeichnis

Foreword.
Preface.
1 Concept and Scope of Benefit-Risk Evaluation ofMedicines.
1.1 Historical backgroun.
1.2 The regulatory systems for assessing medicines.
1.3 Benefit-risk assessment: definitions.
1.4 Views and perceptions of benefits and risks ofmedicines.
1.5 Stages and concepts in benefit-risk assessment.
1.6 Benefit-risk assessment: the current regulatoryenvironment.
1.7 Benefit-risk assessment in other disciplines.
1.8 Specific methods and models for benefit-riskassessment.
1.9 Discussions with stakeholders on the concepts and models forbenefit-risk evaluation.
2 Criteria for a Benefit-Risk Model: a ConceptualFramework.
2.1 Introduction.
2.2 Regulatory guidelines on benefit and risk criteria.
2.3 Identification, definition and rationale of relevant benefitand risk criteria.
2.4 Verification of the list of benefit and risk criteria bymeans of a survey.
3 Review of the Current Benefit-Risk AssessmentModels.
3.1 Background.
3.2 Evaluation of the existing benefit-risk assessmentmodels.
3.3 Review of models in single clinical trials and for specificmedicines.
3.4 Conclusion.
3.5 Newer models.
4 Defining a Systematic Approach to Decision Making.
4.1 Introduction.
4.2 Objectives and features of the ideal model forbenefit-risk assessment.
4.3 The use of decision-analysis techniques for the developmentof the new model.
5 Development and Application of a Benefit-RiskAssessment Model Based on Multi-Criteria Decision Analysis.
5.1 Introduction.
5.2 Conceptualization of the new model.
5.3 Reasons for using decision analysis techniques in the newmodel.
5.4 The use of MCDA in the new model.
5.5 Development of the new model.
5.6 Applicability of the new model.
5.7 Summary.
5.8 Review of the MCDA model.
6 A Future Framework for Benefit-Risk Appraisal ofMedicines.
6.1 Background.
6.2 Development of a benefit-risk framework for regulatoryreview of new medicines.
6.3 Prerequisites of a benefit-risk framework for theregistration of a new medicine.
6.4 Current status of benefit-risk assessment amongcompanies and agencies.
6.5 Constructing a benefit-risk framework.
6.6 Conclusion.
Appendices.
Appendix 1 Summary Reports of the CMR International Institutefor Regulatory Science March 2004 and June 2005 Workshops onBenefit-Risk.
Appendix 2 Office of Health Economics Briefing: Challenges andOpportunities for Improving Benefit-risk Assessment ofPharmaceuticals from an Economic Perspective - James Crossand Louis Garrison (August 2008).
Appendix 3 Reflection Paper on Benefit-risk AssessmentMethods in the Context of the Evaluation of Marketing AuthorisationApplications of Medicinal Products for Human Use - Committeefor Medicinal Products for Human Use (March 2008).
Appendix 4 Commentaries on 'A Quantitative Approach toBenefit-risk Assessment of Medicines'Pharmacoepidemiology and Drug Safety, 2007, 16.
Appendix 5 Forum on Benefit: Risk Decision Analysis -Summary of Discussions and Recommendations - MHRA(September 2008).
References.
Index.

Über Autor(innen)

Dr Sam Salek, Reader in Pharmacoepidemiology, Director - WSP Centre for Socioeconomic Research; Director - Postgraduate Course in Pharmaceutical Medicine, Cardiff University, UK.

Mr Filip Mussen, Johnson & Johnson Pharmaceuticals Research and Development, Belgium.

Prof Stuart Walker, President and Founder, International Institute for Regulatory Science, UK.