{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T00:57:18Z","timestamp":1780534638164,"version":"3.54.1"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,7,8]],"date-time":"2020-07-08T00:00:00Z","timestamp":1594166400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,7,8]],"date-time":"2020-07-08T00:00:00Z","timestamp":1594166400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Approval of regulated medical products in the USA is based upon a rigorous review of the benefits and risks as performed by the US Food and Drug Administration (FDA) staff of scientists and is summarized in a descriptive and qualitative format called the FDA\u2019s Benefit\u2013Risk Framework (BRF). This present method highlights the key factors in regulatory decision-making, but does not clearly define the reason for its final approval.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Method<\/jats:title>\n                <jats:p>This study proposes a quantitative version of FDA\u2019s BRF to calculate a Net-Benefit Score and a Benefit\u2013Risk Ratio as a method to define a single-value summary of the tradeoffs between benefits and risks and allow comparisons among other products. In this retrospective review of five years of new molecular entities and new biologic (<jats:italic>N<\/jats:italic>\u2009=\u2009185 products) regulatory decision-making, this proposed scoring system codifies and quantitates the information about a product\u2019s benefits, risks, and risk management information in a format that may predict why regulated medical products are approved in the USA.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Simple calculation of codified benefits, risks, and risk mitigations with numerical limits is proposed to provide a repeatable process and transparency for documenting the net-benefit of regulatory product approval.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Use of a strict process of collecting, codifying, and analyzing public information to determine a Net-Benefit score and a Benefit\u2013Risk Ratio is possible to anticipate regulatory product approval.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s43441-020-00197-1","type":"journal-article","created":{"date-parts":[[2020,7,8]],"date-time":"2020-07-08T18:03:33Z","timestamp":1594231413000},"page":"129-137","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Predicting Regulatory Product Approvals Using a Proposed Quantitative Version of FDA\u2019s Benefit\u2013Risk Framework to Calculate Net-Benefit Score and Benefit\u2013Risk Ratio"],"prefix":"10.1007","volume":"55","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0046-6874","authenticated-orcid":false,"given":"Stephen","family":"Sun","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzanne","family":"Heske","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melanie","family":"Mercadel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean","family":"Wimmer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,7,8]]},"reference":[{"key":"197_CR1","unstructured":"US Food and Drug Administration (FDA). Benefit\u2013risk assessment in drug regulatory decision-making. Draft PDUFA VI Implementation Plan (FY2018-2022). Mar 30, 2018."},{"key":"197_CR2","unstructured":"National Institutes of Health (NIH). Grants & Funding. Scoring Guidance. Link: https:\/\/grants.nih.gov\/grants\/policy\/review\/rev_prep\/scoring.htm. Accessed: May 29, 2020."},{"key":"197_CR3","doi-asserted-by":"publisher","first-page":"425","DOI":"10.1177\/2168479014565469","volume":"49","author":"MW Colopy","year":"2015","unstructured":"Colopy MW, Darmaraju CV, He W, et al. Benefit\u2013risk evaluation and decision making: Some practical insights. Thera Innov Reg Sci. 2015;49:425\u201333.","journal-title":"Thera Innov Reg Sci"},{"key":"197_CR4","doi-asserted-by":"publisher","first-page":"206","DOI":"10.1186\/s12883-015-0450-x","volume":"15","author":"O Caster","year":"2015","unstructured":"Caster O, Edwards IR. Quantitative benefit\u2013risk assessment of methylprednisolone in multiple sclerosis relapses. BMC Neurol. 2015;15:206.","journal-title":"BMC Neurol"},{"key":"197_CR5","doi-asserted-by":"publisher","first-page":"295","DOI":"10.1007\/s40264-015-0349-x","volume":"29","author":"WE Bennett","year":"2016","unstructured":"Bennett WE. Quantitative risk\u2013benefit analysis of probiotic use for irritable bowel syndrome and inflammatory bowel disease. Drug Saf. 2016;29:295\u2013305.","journal-title":"Drug Saf"},{"issue":"5","key":"197_CR6","doi-asserted-by":"publisher","first-page":"568","DOI":"10.1177\/2168479017698190","volume":"51","author":"MJ Costa","year":"2017","unstructured":"Costa MJ, He W, Jemiai Y, et al. The Case for a Bayesian approach to benefit\u2013risk assessment: overview and future directions. Ther Innov Reg Sci. 2017;51(5):568\u201374.","journal-title":"Ther Innov Reg Sci"},{"issue":"4","key":"197_CR7","doi-asserted-by":"publisher","first-page":"418","DOI":"10.1111\/j.1524-4733.2010.00694.x","volume":"13","author":"FR Johnson","year":"2010","unstructured":"Johnson FR, Hauber AB, Ozdemir S, Lynd L. Quantifying women\u2019s stated benefit\u2013risk trade-off preferences for IBS treatment outcomes. Value Health. 2010;13(4):418\u201323.","journal-title":"Value Health"},{"key":"197_CR8","doi-asserted-by":"publisher","first-page":"741","DOI":"10.1016\/j.jval.2016.04.008","volume":"19","author":"FR Johnson","year":"2016","unstructured":"Johnson FR, Zhou M. Patient preferences in regulatory benefit\u2013risk assessments: a US perspective. 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The products reviewed in this study may have involved the support and services of Syneos Health to achieve its approval but is unknown to the authors which products were actually supported by the company.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}