{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T01:21:32Z","timestamp":1767144092927,"version":"build-2238731810"},"reference-count":13,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2024,1,24]],"date-time":"2024-01-24T00:00:00Z","timestamp":1706054400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2024,1,24]],"date-time":"2024-01-24T00:00:00Z","timestamp":1706054400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2024,5]]},"DOI":"10.1007\/s43441-023-00611-4","type":"journal-article","created":{"date-parts":[[2024,1,24]],"date-time":"2024-01-24T10:20:15Z","timestamp":1706091615000},"page":"415-422","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Incorporating Prior Data in Quantitative Benefit\u2013Risk Assessments: Case Study of a Bayesian Method"],"prefix":"10.1007","volume":"58","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9287-5810","authenticated-orcid":false,"given":"Sai","family":"Dharmarajan","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhong","family":"Yuan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yeh-Fong","family":"Chen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Leila","family":"Lackey","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Saurabh","family":"Mukhopadhyay","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pritibha","family":"Singh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ram","family":"Tiwari","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,1,24]]},"reference":[{"key":"611_CR1","doi-asserted-by":"publisher","first-page":"415","DOI":"10.1007\/s43441-020-00230-3","volume":"55","author":"MY Smith","year":"2021","unstructured":"Smith MY, van Til J, DiSantostefano RL, Hauber AB, Marsh K. Quantitative benefit\u2013risk assessment: state of the practice within industry. Therap Innovat Regulat Sci. 2021;55:415\u201325.","journal-title":"Therap Innovat Regulat Sci"},{"key":"611_CR3","unstructured":"FDA Review of Rivaroxaban for Symptomatic PAD. Available at https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2022\/202439Orig1s035.pdf . Accessed August 3, 2023."},{"key":"611_CR2","unstructured":"FDA Draft Guidance on Benefit-Risk Assessment for New Drug and Biological Products. Available at https:\/\/www.fda.gov\/media\/152544\/download . Accessed August 3, 2023"},{"key":"611_CR4","doi-asserted-by":"publisher","first-page":"125","DOI":"10.1016\/j.jval.2015.12.016","volume":"19","author":"K Marsh","year":"2016","unstructured":"Marsh K, Ijzerman M, Thokala P, et al. Multiple criteria decision analysis for health care decision making\u2013emerging good practices: report 2 of the ISPOR MCDA emerging good practices task force. Value Health. 2016;19:125\u201337.","journal-title":"Value Health"},{"key":"611_CR5","doi-asserted-by":"publisher","DOI":"10.1017\/CBO9781139174084","volume-title":"Decisions with multiple objectives: preferences and value trade-offs","author":"RL Keeney","year":"1993","unstructured":"Keeney RL, Raiffa H. Decisions with multiple objectives: preferences and value trade-offs. Cambridge, England: Cambridge University Press; 1993."},{"key":"611_CR6","doi-asserted-by":"crossref","unstructured":"Belton V, Stewart T. 2002 Multiple Criteria Decision Analysis: an Integrated Approach. New York, NY: Springer Science and Business Media.","DOI":"10.1007\/978-1-4615-1495-4"},{"key":"611_CR7","volume-title":"Smart choices: A practical guide to making better decisions","author":"J Hammond","year":"1999","unstructured":"Hammond J, Keeney R, Raiffa H. Smart choices: A practical guide to making better decisions. Cambridge, England: Harvard Business School Press; 1999."},{"issue":"4","key":"611_CR8","doi-asserted-by":"publisher","first-page":"1023","DOI":"10.1111\/biom.12242","volume":"70","author":"H Schmidli","year":"2014","unstructured":"Schmidli H, Gsteiger S, Roychoudhury S, O\u2019Hagan A, Spiegelhalter D, Neuenschwander B. Robust meta-analytic-predictive priors in clinical trials with historical control information. Biometrics. 2014;70(4):1023\u201332.","journal-title":"Biometrics"},{"issue":"1","key":"611_CR9","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.jval.2015.12.003","volume":"19","author":"P Thokala","year":"2016","unstructured":"Thokala P, Devlin N, Marsh K, Baltussen R, Boysen M, Kalo Z, Longrenn T, Mussen F, Peacock S, Watkins J, Ijzerman M. Multiple criteria decision analysis for health care decision making\u2014an introduction: report 1 of the ISPOR MCDA Emerging Good Practices Task Force. Value Health. 2016;19(1):1\u20133.","journal-title":"Value Health"},{"issue":"21","key":"611_CR10","doi-asserted-by":"publisher","first-page":"1994","DOI":"10.1056\/NEJMoa2000052","volume":"382","author":"MP Bonaca","year":"2020","unstructured":"Bonaca MP, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Patel MR, Fanelli F, Capell WH, Diao L, Jaeger N, Hess CN, Pap AF, Kittelson JM, Gudz I, M\u00e1ty\u00e1s L, Krievins DK, Diaz R, Brodmann M, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR. Rivaroxaban in peripheral artery disease after revascularization. N Engl J Med. 2020;382(21):1994\u20132004. https:\/\/doi.org\/10.1056\/NEJMoa2000052. (Epub 2020 Mar 28 PMID: 32222135).","journal-title":"N Engl J Med"},{"issue":"2","key":"611_CR11","doi-asserted-by":"publisher","first-page":"459","DOI":"10.1016\/j.dss.2012.10.005","volume":"55","author":"G Van Valkenhoef","year":"2013","unstructured":"Van Valkenhoef G, Tervonen T, Zwinkels T, De Brock B, Hillege H. ADDIS: a decision support system for evidence-based medicine. Decis Support Syst. 2013;55(2):459\u201375.","journal-title":"Decis Support Syst"},{"issue":"6","key":"611_CR12","doi-asserted-by":"publisher","first-page":"954","DOI":"10.1080\/10543406.2021.2021227","volume":"32","author":"H Li","year":"2022","unstructured":"Li H, Tiwari R, Li QH. Conditional borrowing external data to establish a hybrid control arm in randomized clinical trials. J Biopharm Stat. 2022;32(6):954\u201368.","journal-title":"J Biopharm Stat"},{"issue":"1","key":"611_CR13","doi-asserted-by":"publisher","first-page":"52","DOI":"10.1080\/19466315.2018.1527248","volume":"11","author":"S Mukhopadhyay","year":"2019","unstructured":"Mukhopadhyay S, Dilley K, Oladipo A, Jokinen J. Hierarchical bayesian benefit-risk modeling and assessment using choice based conjoint. Stat Biopharmaceut Res. 2019;11(1):52\u201360.","journal-title":"Stat Biopharmaceut Res"}],"updated-by":[{"DOI":"10.1007\/s43441-024-00625-6","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2024,2,12]],"date-time":"2024-02-12T00:00:00Z","timestamp":1707696000000}}],"container-title":["Therapeutic Innovation & Regulatory Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-023-00611-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s43441-023-00611-4\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-023-00611-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,4,24]],"date-time":"2024-04-24T17:34:27Z","timestamp":1713980067000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s43441-023-00611-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1,24]]},"references-count":13,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2024,5]]}},"alternative-id":["611"],"URL":"https:\/\/doi.org\/10.1007\/s43441-023-00611-4","relation":{},"ISSN":["2168-4790","2168-4804"],"issn-type":[{"value":"2168-4790","type":"print"},{"value":"2168-4804","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1,24]]},"assertion":[{"value":"2 October 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 December 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 January 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 February 2024","order":4,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Correction","order":5,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"A Correction to this paper has been published:","order":6,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"https:\/\/doi.org\/10.1007\/s43441-024-00625-6","URL":"https:\/\/doi.org\/10.1007\/s43441-024-00625-6","order":7,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"On behalf of all authors, the corresponding author states that there is no conflict of interest.\u00a0At the time the study was conducted, and manuscript written the corresponding author, Sai Dharmarajan,\u00a0was an employee of Food and Drug Administration. At the time of manuscript submission, Sai Dharmarajan\u00a0was an employee of Sarepta Therapeutics. The data\/content are independent of any Sarepta Therapeutics assets or interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}