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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.
Autorentext
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.
Klappentext
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 and their regulatory reviews. This model utilises a multi-criteria decision analysis which involves selecting, scoring and weighting key benefit and risk attributes and leads to an overall balanced appraisal 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.
Inhalt
Foreword.
Preface.
1 Concept and Scope of BenefitRisk Evaluation of Medicines.
1.1 Historical backgroun.
1.2 The regulatory systems for assessing medicines.
1.3 Benefitrisk assessment: definitions.
1.4 Views and perceptions of benefits and risks of medicines.
1.5 Stages and concepts in benefitrisk assessment.
1.6 Benefitrisk assessment: the current regulatory environment.
1.7 Benefitrisk assessment in other disciplines.
1.8 Specific methods and models for benefitrisk assessment.
1.9 Discussions with stakeholders on the concepts and models for benefitrisk evaluation.
2 Criteria for a BenefitRisk 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 BenefitRisk Assessment Models.
3.1 Background.
3.2 Evaluation of the existing benefitrisk 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 benefitrisk assessment.
4.3 The use of decision-analysis techniques for the development of the new model.
5 Development and Application of a BenefitRisk 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 BenefitRisk Appraisal of Medicines.
6.1 Background.
6.2 Development of a benefitrisk framework for regulatory review of new medicines.
6.3 Prerequisites of a benefitrisk framework for the registration of a new medicine.
6.4 Current status of benefitrisk assessment among companies and agencies.
6.5 Constructing a benefitrisk framework.
6.6 Conclusion.
Appendices.
Appendix 1 Summary Reports of the CMR International Institute for Regulatory Science March 2004 and June 2005 Workshops on BenefitRisk.
Appendix 2 Office of Health Economics Briefing: Challenges and Opportunities for Improving Benefitrisk Assessment of Pharmaceuticals from an Economic Perspective James Cross and Louis Garrison (August 2008).
Appendix 3 Reflection Paper on Benefitrisk 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 Benefitrisk 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.