Filip Mussen, Sam Salek, Stuart Walker

Benefit-Risk Appraisal of Medicines (eBook, PDF)

A Systematic Approach to Decision-making

• Format: PDF

Produktbeschreibung

Benefit-risk assessment is at the centre of the approval process for every new medicine. The ability to assess the risks of a new medicine accurately and to balance these against the benefits the medicine could bring is critical for every regulatory authority and pharmaceutical company. Despite this there are very few tried and tested evaluative models currently available. The authors of this book have developed a new, pioneering tool for the assessment of benefits and risks for new medicines in development. This model utilises a multi-criteria decision analysis which involves selecting, scoring and weighting key benefit and risk attributes and leads to an overall appraisal of benefits and risks of medicines. Benefit-Risk Appraisal of Medicines establishes the background and criteria required to assess benefit and risk in general and reviews the current practices by regulatory authorities and the pharmaceutical industry, including those models currently available. It outlines the development and evaluation of the authors' new model and analyses the implications of its implementation. * Describes an innovative, systematic model which leads to transparent and responsible benefit-risk decision making * Contributes important ideas to the debate on benefit-risk appraisal * Provides a future framework for benefit-risk appraisal of medicines Benefit-Risk Appraisal of Medicines covers the entire process from the discovery of new medicines to their marketing and is ideal for all those who work in the pharmaceutical industry and regulatory authorities,, as well as post-graduate students of pharmaceutical medicine and clinical pharmacology.

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Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 304
• Erscheinungstermin: 20. Juli 2009
• Englisch
• ISBN-13: 9780470748121
• Artikelnr.: 37299229

Autorenporträt

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.

Inhaltsangabe

Foreword.
Preface.
1 Concept and Scope of Benefit-Risk Evaluation of Medicines.
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 of medicines.
1.5 Stages and concepts in benefit-risk assessment.
1.6 Benefit-risk assessment: the current regulatory environment.
1.7 Benefit-risk assessment in other disciplines.
1.8 Specific methods and models for benefit-risk assessment.
1.9 Discussions with stakeholders on the concepts and models for
benefit-risk evaluation.
2 Criteria for a Benefit-Risk Model: a Conceptual Framework.
2.1 Introduction.
2.2 Regulatory guidelines on benefit and risk criteria.
2.3 Identification, definition and rationale of relevant benefit and risk
criteria.
2.4 Verification of the list of benefit and risk criteria by means of a
survey.
3 Review of the Current Benefit-Risk Assessment Models.
3.1 Background.
3.2 Evaluation of the existing benefit-risk assessment models.
3.3 Review of models in single clinical trials and for specific medicines.
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 for benefit-risk assessment.
4.3 The use of decision-analysis techniques for the development of the new
model.
5 Development and Application of a Benefit-Risk Assessment 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 new model.
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 of Medicines.
6.1 Background.
6.2 Development of a benefit-risk framework for regulatory review of new
medicines.
6.3 Prerequisites of a benefit-risk framework for the registration of a new
medicine.
6.4 Current status of benefit-risk assessment among companies and agencies.
6.5 Constructing a benefit-risk framework.
6.6 Conclusion.
Appendices.
Appendix 1 Summary Reports of the CMR International Institute for
Regulatory Science March 2004 and June 2005 Workshops on Benefit-Risk.
Appendix 2 Office of Health Economics Briefing: Challenges and
Opportunities for Improving Benefit-risk Assessment of Pharmaceuticals from
an Economic Perspective - James Cross and Louis Garrison (August 2008).
Appendix 3 Reflection Paper on Benefit-risk Assessment Methods in the
Context of the Evaluation of Marketing Authorisation Applications of
Medicinal Products for Human Use - Committee for Medicinal Products for
Human Use (March 2008).
Appendix 4 Commentaries on 'A Quantitative Approach to Benefit-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.