Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions.
Structured frameworks for benefit-risk analysis in drug licensing decisions are being implemented across a number of regulatory agencies worldwide. The aim of these frameworks is to aid the analysis and communication of the benefit-risk assessment throughout the development, evaluation, and supervision of medicines. In this review, authors from regulatory agencies, pharmaceutical companies, and academia share their views on the different frameworks and discuss future directions.
The European Medicines Agency, London, United Kingdom.
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Pignatti
School of Public Health, Imperial College London, London, United Kingdom.
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Ashby
Department of Medicine, Harbor-UCLA Medical Center, Torrance, California, USA.
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Brass
The European Medicines Agency, London, United Kingdom.
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Eichler
Food and Drug Administration, Silver Spring, Maryland, USA.
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Frey
University of Groningen, Groningen, The Netherlands.
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Hillege
Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
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Hori
Janssen Pharmaceutical Research and Development, Titusville, New Jersey, USA.
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Levitan
Centre for Innovation in Regulatory Science (CIRS), London, United Kingdom.
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Liberti
Risk Research Group, Centre for Environmental Strategy, University of Surrey, Guildford, United Kingdom.
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Löfstedt
Centre for Innovation in Regulatory Science (CIRS), London, United Kingdom.
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McAuslane
Merck Serono, Geneva, Switzerland.
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Micaleff
Eli Lilly and Company, Indianapolis, Indiana, USA.
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Noel
The European Medicines Agency, London, United Kingdom.
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Postmus
Institut für Sozialwissenschaften, Universität Stuttgart, Stuttgart, Germany.
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Renn
Health Canada, Ottawa, Ontario, Canada.
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Sabourin
Läkemedelsverket, Uppsala, Sweden.
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Salmonson
Centre for Innovation in Regulatory Science (CIRS), London, United Kingdom.
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S
Walker
D003142:Communication; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000453:epidemiology; D005060:Europe; D005544:Forecasting; D006077:Government Agencies / Q000592:standards / Q000639:trends*; D006801:Humans; D018570:Risk Assessment / Q000379:methods / Q000639:trends*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards / Q000639:trends*