{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T00:02:24Z","timestamp":1784592144981,"version":"3.55.0"},"reference-count":36,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2020,1,1]],"date-time":"2020-01-01T00:00:00Z","timestamp":1577836800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Drug Safety"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:p>A favorable benefit\u2013risk profile remains an essential requirement for marketing authorization of medicinal drugs and devices. Furthermore, prior subjective, implicit and inconsistent ad hoc benefit\u2013risk assessment methods have rightly evolved towards more systematic, explicit or \u201cstructured\u201d approaches. Contemporary structured benefit\u2013risk evaluation aims at providing an objective assessment of the benefit\u2013risk profile of medicinal products and a higher transparency for decision making purposes. The use of a descriptive framework should be the preferred starting point for a structured benefit\u2013risk assessment. In support of more precise assessments, quantitative and semi-quantitative methodologies have been developed and utilized to complement descriptive or qualitative frameworks in order to facilitate the structured evaluation of the benefit\u2013risk profile of medicinal products. In addition, quantitative structured benefit\u2013risk analysis allows integration of patient preference data. Collecting patient perspectives throughout the medical product development process has become increasingly important and key to the regulatory decision-making process. Both industry and regulatory authorities increasingly rely on descriptive structured benefit\u2013risk evaluation and frameworks in drug, vaccine and device evaluation and comparison. Although varied qualitative methods are more commonplace, quantitative approaches have recently been emphasized. However, it is unclear how frequently these quantitative frameworks have been used by pharmaceutical companies to support submission dossiers for drug approvals or to respond to the health authorities\u2019 requests. The objective of this study has been to identify and review, for the first time, currently available, published, structured, quantitative benefit\u2013risk evaluations which may have informed health care professionals and\/or payor as well as contributed to decision making purposes in the regulatory setting for drug, vaccine and\/or device approval.<\/jats:p>\n                  <jats:sec>\n                    <jats:title>Plain language summary<\/jats:title>\n                    <jats:p>Quantitative evaluation of the benefit\u2013risk balance for medicinal products The review of the benefits and the risks associated with a medicinal product is called benefit\u2013risk assessment. One of the conditions for a medicinal product to receive marketing authorization is to demonstrate a positive benefit\u2013risk balance in which the benefits outweigh the risks. In order to enhance the transparency and consistency in the assessment of benefit\u2013risk balance, frameworks and quantitative methods have been developed for decision making purposes and regulatory approvals of medicinal products. This article considers published quantitative benefit\u2013risk evaluations which may have informed health care professionals and\/or payor as well as contributed to decision making purposes in the regulatory setting for drug, vaccine and\/or device approval.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/2042098620976951","type":"journal-article","created":{"date-parts":[[2020,12,10]],"date-time":"2020-12-10T13:03:02Z","timestamp":1607605382000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":43,"title":["Structured benefit\u2013risk evaluation for medicinal products: review of quantitative benefit\u2013risk assessment findings in the literature"],"prefix":"10.1177","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2606-776X","authenticated-orcid":false,"given":"Marie-Laure","family":"K\u00fcrzinger","sequence":"first","affiliation":[{"name":"Global Epidemiology & Benefit\u2013Risk Evaluation, Sanofi, 1, Avenue Pierre Brossolette \u2013 91385 Chilly-Mazarin, 91000, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ludivine","family":"Douarin","sequence":"additional","affiliation":[{"name":"Global Epidemiology & Benefit\u2013Risk Evaluation, Sanofi, Chilly-Mazarin, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ievgeniia","family":"Uzun","sequence":"additional","affiliation":[{"name":"Global Epidemiology & Benefit\u2013Risk Evaluation, Sanofi, Bridgewater, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chantal","family":"El-Haddad","sequence":"additional","affiliation":[{"name":"Global Epidemiology & Benefit\u2013Risk Evaluation, Sanofi, Chilly-Mazarin, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Hurst","sequence":"additional","affiliation":[{"name":"Global Epidemiology & Benefit\u2013Risk Evaluation, Sanofi, Bridgewater, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8235-8388","authenticated-orcid":false,"given":"Juhaeri","family":"Juhaeri","sequence":"additional","affiliation":[{"name":"Global Epidemiology & Benefit\u2013Risk Evaluation, Sanofi, Bridgewater, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"St\u00e9phanie","family":"Tcherny-Lessenot","sequence":"additional","affiliation":[{"name":"Global Epidemiology & Benefit\u2013Risk Evaluation, Sanofi, Chilly-Mazarin, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2020,12,8]]},"reference":[{"key":"bibr1-2042098620976951","doi-asserted-by":"publisher","DOI":"10.1177\/2042098619871180"},{"key":"bibr2-2042098620976951","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3636"},{"key":"bibr3-2042098620976951","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3958"},{"key":"bibr4-2042098620976951","volume-title":"Benefit\u2013risk assessment in drug regulatory decision-making 2018: draft PDUFA VI implementation plan (FY 2018-2022)","author":"US Food and Drug Administration","year":"2018"},{"key":"bibr5-2042098620976951","doi-asserted-by":"publisher","DOI":"10.1017\/CBO9781139506779"},{"key":"bibr6-2042098620976951","unstructured":"Hammond JS, Keeney RL, Raiffa H. 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