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Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents

The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia's Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation template developed by the Centre for Innovati...

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Detalles Bibliográficos
Autores principales: Leong Wai Yeen, James, Salek, Sam, Walker, Stuart
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4255503/
https://www.ncbi.nlm.nih.gov/pubmed/25538620
http://dx.doi.org/10.3389/fphar.2014.00269
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author Leong Wai Yeen, James
Salek, Sam
Walker, Stuart
author_facet Leong Wai Yeen, James
Salek, Sam
Walker, Stuart
author_sort Leong Wai Yeen, James
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description The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia's Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation template developed by the Centre for Innovation in Regulatory Science and a four-member Consortium on Benefit-Risk Assessment. A case study was also conducted using a US FDA Medical Review, the European Public Assessment Report and Australia's Public Assessment Report for the same product. Compared with the BR Template, existing regulatory report formats are inadequate regarding the listing of benefits and risks, the assigning of relative importance and values, visualization and the utilization of a detailed, systematic, standardized structure. The BR Template is based on the principles of BR assessment common to major regulatory agencies. Given that there are minimal differences among the existing regulatory report formats, it is timely to consider the feasibility of a universal template.
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spelling pubmed-42555032014-12-23 Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents Leong Wai Yeen, James Salek, Sam Walker, Stuart Front Pharmacol Pharmacology The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia's Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation template developed by the Centre for Innovation in Regulatory Science and a four-member Consortium on Benefit-Risk Assessment. A case study was also conducted using a US FDA Medical Review, the European Public Assessment Report and Australia's Public Assessment Report for the same product. Compared with the BR Template, existing regulatory report formats are inadequate regarding the listing of benefits and risks, the assigning of relative importance and values, visualization and the utilization of a detailed, systematic, standardized structure. The BR Template is based on the principles of BR assessment common to major regulatory agencies. Given that there are minimal differences among the existing regulatory report formats, it is timely to consider the feasibility of a universal template. Frontiers Media S.A. 2014-12-04 /pmc/articles/PMC4255503/ /pubmed/25538620 http://dx.doi.org/10.3389/fphar.2014.00269 Text en Copyright © 2014 Leong Wai Yeen, Salek and Walker. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Leong Wai Yeen, James
Salek, Sam
Walker, Stuart
Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents
title Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents
title_full Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents
title_fullStr Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents
title_full_unstemmed Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents
title_short Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents
title_sort strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4255503/
https://www.ncbi.nlm.nih.gov/pubmed/25538620
http://dx.doi.org/10.3389/fphar.2014.00269
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