Global Landscape of Benefit-Risk Considerations for Medicinal Products: Current State and Future Directions.

IF 3.1 Q2 PHARMACOLOGY & PHARMACY Pharmaceutical Medicine Pub Date : 2022-08-01 Epub Date: 2022-07-03 DOI:10.1007/s40290-022-00435-x
Max Waschbusch, Lisa Rodriguez, Andreas Brueckner, Kerry Jo Lee, Xuefeng Li, Oksana Mokliatchouk, Lothar Tremmel, Shuai S Yuan
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Abstract

In the last decade there has been a significant increase in the literature discussing the use of benefit-risk methods in medical product (including devices) development. Government agencies, medical product industry groups, academia, and collaborative consortia have extensively discussed the advantages of structured benefit-risk assessments. However, the abundance of information has not resulted in a consistent way to utilize these findings in medical product development. Guidelines and papers on methods, even though well structured, have not led to a firm consensus on a clear and consistent approach. This paper summarizes the global landscape of benefit-risk considerations for product- or program-level decisions from available literature and regulatory guidance, providing the perspectives of three stakeholder groups-regulators, collaborative groups and consortia, and patients. The paper identifies key themes, potential impact on benefit-risk assessments, and significant future trends.

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医药产品利益风险考量的全球格局:现状和未来方向。
在过去十年中,讨论在医疗产品(包括器械)开发中使用利益-风险方法的文献显著增加。政府机构、医疗产品行业团体、学术界和合作联盟广泛讨论了结构化收益-风险评估的优势。然而,丰富的信息并没有导致在医疗产品开发中使用这些发现的一致方式。关于方法的指导方针和文件虽然结构良好,但并没有就明确和一致的办法达成坚定的协商一致意见。本文从现有文献和监管指导中总结了产品或项目层面决策的利益风险考虑的全球格局,并提供了三个利益相关者群体——监管机构、合作团体和财团以及患者的观点。该文件确定了关键主题,对利益风险评估的潜在影响,以及重要的未来趋势。
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来源期刊
Pharmaceutical Medicine
Pharmaceutical Medicine PHARMACOLOGY & PHARMACY-
CiteScore
5.10
自引率
4.00%
发文量
36
期刊介绍: Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
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