{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T17:47:36Z","timestamp":1786988856773,"version":"build-2736575974"},"reference-count":18,"publisher":"Elsevier BV","issue":"12","license":[{"start":{"date-parts":[[2024,12,1]],"date-time":"2024-12-01T00:00:00Z","timestamp":1733011200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2024,12,1]],"date-time":"2024-12-01T00:00:00Z","timestamp":1733011200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2024,10,21]],"date-time":"2024-10-21T00:00:00Z","timestamp":1729468800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["esmoopen.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["ESMO Open"],"published-print":{"date-parts":[[2024,12]]},"DOI":"10.1016\/j.esmoop.2024.103991","type":"journal-article","created":{"date-parts":[[2024,12,9]],"date-time":"2024-12-09T10:25:14Z","timestamp":1733739914000},"page":"103991","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":7,"title":["Uncertainties about the benefit-risk balance of oncology medicines assessed by the European Medicines Agency"],"prefix":"10.1016","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3002-3911","authenticated-orcid":false,"given":"A.C.","family":"Taams","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.A.","family":"Herberts","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1758-7779","authenticated-orcid":false,"given":"A.C.G.","family":"Egberts","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Zafiropoulos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F.","family":"Pignatti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0014-8625","authenticated-orcid":false,"given":"L.T.","family":"Bloem","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"2","key":"10.1016\/j.esmoop.2024.103991_bib2","doi-asserted-by":"crossref","first-page":"350","DOI":"10.1002\/cpt.1835","article-title":"Decision making under uncertainty: comparing regulatory and health technology assessment reviews of medicines in the United States and Europe","volume":"108","author":"Vreman","year":"2020","journal-title":"Clin Pharmacol Ther"},{"issue":"4","key":"10.1016\/j.esmoop.2024.103991_bib3","doi-asserted-by":"crossref","first-page":"1219","DOI":"10.1111\/1468-0009.12476","article-title":"Approval of cancer drugs with uncertain therapeutic value: a comparison of regulatory decisions in Europe and the United States","volume":"98","author":"Salcher-Konrad","year":"2020","journal-title":"Milbank Q"},{"issue":"1","key":"10.1016\/j.esmoop.2024.103991_bib4","doi-asserted-by":"crossref","first-page":"148","DOI":"10.1002\/cpt.2906","article-title":"European conditional marketing authorization in a rapidly evolving treatment landscape: a comprehensive study of anticancer medicinal products in 2006-2020","volume":"114","author":"Bloem","year":"2023","journal-title":"Clin Pharmacol Ther"},{"issue":"4","key":"10.1016\/j.esmoop.2024.103991_bib6","doi-asserted-by":"crossref","first-page":"871","DOI":"10.1002\/cpt.3195","article-title":"A\u00a0natural language processing approach towards harmonized communication of uncertainties identified during the European Medicine Authorization Process","volume":"115","author":"Verweij","year":"2024","journal-title":"Clin Pharmacol Ther"},{"issue":"1","key":"10.1016\/j.esmoop.2024.103991_bib7","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1377\/hlthaff.2023.00466","article-title":"Physicians' perspectives on FDA regulation of drugs and medical devices: a national survey","volume":"43","author":"Dhruva","year":"2024","journal-title":"Health Aff"},{"issue":"14","key":"10.1016\/j.esmoop.2024.103991_bib8","doi-asserted-by":"crossref","first-page":"1516","DOI":"10.1001\/jama.2015.16984","article-title":"Physicians' knowledge about FDA approval standards and perceptions of the \"breakthrough therapy\" designation","volume":"315","author":"Kesselheim","year":"2016","journal-title":"JAMA"},{"issue":"5","key":"10.1016\/j.esmoop.2024.103991_bib9","doi-asserted-by":"crossref","first-page":"707","DOI":"10.1001\/jamainternmed.2018.8121","article-title":"Physicians' perspectives on FDA approval standards and off-label drug marketing","volume":"179","author":"Kesselheim","year":"2019","journal-title":"JAMA Intern Med"},{"issue":"1","key":"10.1016\/j.esmoop.2024.103991_bib10","doi-asserted-by":"crossref","first-page":"e85","DOI":"10.1093\/oncolo\/oyab021","article-title":"Physician perceptions of the FDA\u2019s breakthrough therapy designation: an update","volume":"27","author":"Paquin","year":"2022","journal-title":"Oncologist"},{"key":"10.1016\/j.esmoop.2024.103991_bib11","article-title":"Communication of anticancer drug benefits and related uncertainties to patients and clinicians: document analysis of regulated information on prescription drugs in Europe","volume":"380","author":"Davis","year":"2023","journal-title":"BMJ"},{"issue":"7","key":"10.1016\/j.esmoop.2024.103991_bib12","doi-asserted-by":"crossref","DOI":"10.1016\/j.drudis.2024.104031","article-title":"Healthcare decision-making for tumour-agnostic therapies in Europe: lessons learned","volume":"29","author":"Hogervorst","year":"2024","journal-title":"Drug Discov Today"},{"key":"10.1016\/j.esmoop.2024.103991_bib13","doi-asserted-by":"crossref","first-page":"606","DOI":"10.1016\/j.omtm.2021.11.003","article-title":"Current landscape of clinical development and approval of advanced therapies","volume":"23","author":"Iglesias-Lopez","year":"2021","journal-title":"Mol Ther Methods Clin Dev"},{"issue":"8","key":"10.1016\/j.esmoop.2024.103991_bib14","doi-asserted-by":"crossref","first-page":"853","DOI":"10.1080\/14737167.2023.2245138","article-title":"Gene therapies, uncertainty, and decision-making: thinking about the last mile at the first step","volume":"23","author":"Frederix","year":"2023","journal-title":"Expert Rev Pharmacoecon Outcomes Res"},{"key":"10.1016\/j.esmoop.2024.103991_bib19","unstructured":"European Medicines Agency. Conditional Marketing Authorisation. Available at https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/marketing-authorisation\/conditional-marketing-authorisation, 2024. Accessed June 14, 2024."},{"issue":"1","key":"10.1016\/j.esmoop.2024.103991_bib21","doi-asserted-by":"crossref","first-page":"213","DOI":"10.1111\/bcp.12940","article-title":"Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU","volume":"82","author":"Hoekman","year":"2016","journal-title":"Br J Clin Pharmacol"},{"key":"10.1016\/j.esmoop.2024.103991_bib22","doi-asserted-by":"crossref","first-page":"614","DOI":"10.3390\/ph16040614","article-title":"Agnostic approvals in oncology: getting the right drug to the right patient with the right genomics","volume":"16","author":"Tateo","year":"2023","journal-title":"Pharmaceuticals (Basel)"},{"issue":"6","key":"10.1016\/j.esmoop.2024.103991_bib23","doi-asserted-by":"crossref","first-page":"723","DOI":"10.1038\/clpt.2014.184","article-title":"Risk management plans as a tool for proactive pharmacovigilance: a cohort study of newly approved drugs in Europe","volume":"96","author":"Vermeer","year":"2014","journal-title":"Clin Pharmacol Ther"},{"issue":"12","key":"10.1016\/j.esmoop.2024.103991_bib24","doi-asserted-by":"crossref","first-page":"4233","DOI":"10.1016\/j.jaip.2021.08.024","article-title":"Applying the clinical literature to a science of uncertainty and an art of probability","volume":"9","author":"Shaker","year":"2021","journal-title":"J\u00a0Allergy Clin Immunol Pract"},{"key":"10.1016\/j.esmoop.2024.103991_bib25","year":"2024","journal-title":"Biomarker"}],"container-title":["ESMO Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2059702924017617?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2059702924017617?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,1,7]],"date-time":"2025-01-07T23:43:29Z","timestamp":1736293409000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2059702924017617"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12]]},"references-count":18,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2024,12]]}},"alternative-id":["S2059702924017617"],"URL":"https:\/\/doi.org\/10.1016\/j.esmoop.2024.103991","relation":{},"ISSN":["2059-7029"],"issn-type":[{"value":"2059-7029","type":"print"}],"subject":[],"published":{"date-parts":[[2024,12]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Uncertainties about the benefit-risk balance of oncology medicines assessed by the European Medicines Agency","name":"articletitle","label":"Article Title"},{"value":"ESMO Open","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.esmoop.2024.103991","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2024 The Authors. Published by Elsevier Ltd on behalf of European Society for Medical Oncology.","name":"copyright","label":"Copyright"}],"article-number":"103991"}}