{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T05:22:43Z","timestamp":1790486563944,"version":"4.1.0"},"reference-count":26,"publisher":"American Medical Association (AMA)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"DOI":"10.1001\/jamanetworkopen.2022.16183","type":"journal-article","created":{"date-parts":[[2022,6,10]],"date-time":"2022-06-10T11:35:25Z","timestamp":1654860925000},"page":"e2216183","source":"Crossref","is-referenced-by-count":81,"title":["Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019"],"prefix":"10.1001","volume":"5","author":[{"given":"Mark P.","family":"Lythgoe","sequence":"first","affiliation":[{"name":"Department of Surgery and Cancer, Imperial College London, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aakash","family":"Desai","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Mayo Clinic, Rochester, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bishal","family":"Gyawali","sequence":"additional","affiliation":[{"name":"Division of Cancer Care and Epidemiology, Departments of Oncology and Public Health Sciences, Queen\u2019s University Cancer Research Institute, Kingston, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Savage","sequence":"additional","affiliation":[{"name":"Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Krell","sequence":"additional","affiliation":[{"name":"Department of Surgery and Cancer, Imperial College London, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeremy L.","family":"Warner","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology, Vanderbilt University, Nashville, Tennessee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali Raza","family":"Khaki","sequence":"additional","affiliation":[{"name":"Division of Oncology, Department of Medicine, Stanford University School of Medicine, Palo Alto, California"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2022,6,10]]},"reference":[{"issue":"1","key":"zoi220470r1","doi-asserted-by":"publisher","first-page":"195","DOI":"10.1002\/cpt.v107.1","article-title":"A comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: concordance, discordance, and why.","volume":"107","author":"Kashoki","year":"2020","journal-title":"Clin Pharmacol Ther"},{"key":"zoi220470r2","doi-asserted-by":"publisher","DOI":"10.26633\/RPSP","article-title":"Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries.","volume":"45","author":"Dur\u00e1n","year":"2021","journal-title":"Rev Panam Salud Publica"},{"issue":"5","key":"zoi220470r3","doi-asserted-by":"publisher","first-page":"2312","DOI":"10.1021\/acs.jmedchem.0c01516","article-title":"A decade of FDA-approved drugs (2010-2019): trends and future directions.","volume":"64","author":"Brown","year":"2021","journal-title":"J Med Chem"},{"issue":"4","key":"zoi220470r4","doi-asserted-by":"publisher","first-page":"539","DOI":"10.1001\/jamaoncol.2015.0373","article-title":"Five years of cancer drug approvals: innovation, efficacy, and costs.","volume":"1","author":"Mailankody","year":"2015","journal-title":"JAMA Oncol"},{"issue":"2","key":"zoi220470r5","doi-asserted-by":"publisher","first-page":"301","DOI":"10.1016\/j.drudis.2020.11.011","article-title":"Development and economic trends in anticancer drugs licensed in the UK from 2015 to 2019.","volume":"26","author":"Lythgoe","year":"2021","journal-title":"Drug Discov Today"},{"issue":"1","key":"zoi220470r6","doi-asserted-by":"publisher","first-page":"265","DOI":"10.1093\/annonc\/mdt512","article-title":"How do the EMA and FDA decide which anticancer drugs make it to the market? a comparative qualitative study on decision makers\u2019 views.","volume":"25","author":"Tafuri","year":"2014","journal-title":"Ann Oncol"},{"issue":"14","key":"zoi220470r7","doi-asserted-by":"publisher","first-page":"1386","DOI":"10.1056\/NEJMc1700103","article-title":"Regulatory review of new therapeutic agents - FDA versus EMA, 2011-2015.","volume":"376","author":"Downing","year":"2017","journal-title":"N Engl J Med"},{"issue":"24","key":"zoi220470r8","doi-asserted-by":"publisher","first-page":"2284","DOI":"10.1056\/NEJMsa1200223","article-title":"Regulatory review of novel therapeutics--comparison of three regulatory agencies.","volume":"366","author":"Downing","year":"2012","journal-title":"N Engl J Med"},{"issue":"7","key":"zoi220470r9","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1001276","article-title":"How does medical device regulation perform in the United States and the European union? a systematic review.","volume":"9","author":"Kramer","year":"2012","journal-title":"PLoS Med"},{"issue":"7","key":"zoi220470r10","doi-asserted-by":"publisher","first-page":"1375","DOI":"10.1377\/hlthaff.2011.0231","article-title":"Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe.","volume":"30","author":"Roberts","year":"2011","journal-title":"Health Aff (Millwood)"},{"issue":"15","key":"zoi220470r13","doi-asserted-by":"publisher","first-page":"1575","DOI":"10.1200\/JCO.2021.39.15_suppl.1575","article-title":"Time intervals between U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) new cancer therapy approvals.","volume":"39","author":"Lythgoe","year":"2021","journal-title":"J Clin Oncol"},{"issue":"6","key":"zoi220470r14","doi-asserted-by":"publisher","first-page":"849","DOI":"10.1001\/jamaoncol.2017.5618","article-title":"A 25-year experience of US Food and Drug Administration accelerated approval of malignant hematology and oncology drugs and biologics: a review.","volume":"4","author":"Beaver","year":"2018","journal-title":"JAMA Oncol"},{"key":"zoi220470r15","doi-asserted-by":"publisher","first-page":"h4633","DOI":"10.1136\/bmj.h4633","article-title":"Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.","volume":"351","author":"Kesselheim","year":"2015","journal-title":"BMJ"},{"key":"zoi220470r16","doi-asserted-by":"publisher","first-page":"m3434","DOI":"10.1136\/bmj.m3434","article-title":"Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study.","volume":"371","author":"Hwang","year":"2020","journal-title":"BMJ"},{"issue":"7","key":"zoi220470r17","doi-asserted-by":"publisher","first-page":"626","DOI":"10.1001\/jama.2017.9415","article-title":"Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US Food and Drug Administration.","volume":"318","author":"Naci","year":"2017","journal-title":"JAMA"},{"issue":"7","key":"zoi220470r19","doi-asserted-by":"publisher","first-page":"1304","DOI":"10.1158\/1055-9965.EPI-19-1534","article-title":"Medical care costs associated with cancer survivorship in the United States.","volume":"29","author":"Mariotto","year":"2020","journal-title":"Cancer Epidemiol Biomarkers Prev"},{"issue":"11","key":"zoi220470r20","doi-asserted-by":"publisher","first-page":"1607","DOI":"10.1001\/jamaoncol.2021.3046","article-title":"The oncologic drugs advisory committee votes of April 2021-implications for the fate of accelerated approval.","volume":"7","author":"Powell","year":"2021","journal-title":"JAMA Oncol"},{"issue":"7","key":"zoi220470r21","doi-asserted-by":"publisher","first-page":"906","DOI":"10.1001\/jamainternmed.2019.0462","article-title":"Assessment of the clinical benefit of cancer drugs receiving accelerated approval.","volume":"179","author":"Gyawali","year":"2019","journal-title":"JAMA Intern Med"},{"issue":"26","key":"zoi220470r22","doi-asserted-by":"publisher","first-page":"4398","DOI":"10.1200\/JCO.2008.21.1961","article-title":"Accelerated approval of cancer drugs: improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs?","volume":"27","author":"Richey","year":"2009","journal-title":"J Clin Oncol"},{"issue":"8","key":"zoi220470r23","doi-asserted-by":"publisher","first-page":"1453","DOI":"10.1377\/hlthaff.2014.0122","article-title":"Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals.","volume":"33","author":"Frank","year":"2014","journal-title":"Health Aff (Millwood)"},{"issue":"24","key":"zoi220470r24","doi-asserted-by":"publisher","first-page":"6412","DOI":"10.1158\/1078-0432.CCR-20-3292","article-title":"Project orbis: Global collaborative review program.","volume":"26","author":"de Claro","year":"2020","journal-title":"Clin Cancer Res"},{"issue":"15_suppl","key":"zoi220470r25","doi-asserted-by":"publisher","first-page":"2071","DOI":"10.1200\/JCO.2020.38.15_suppl.2071","article-title":"Timing of US Food and Drug Administration (FDA) cancer drug approvals relative to publication of clinical trial results.","volume":"38","author":"Khaki","year":"2020","journal-title":"J Oncol"},{"issue":"12","key":"zoi220470r26","doi-asserted-by":"publisher","first-page":"637","DOI":"10.1038\/s41408-017-0008-9","article-title":"Time from US Food and Drug Administration approval to publication of data for cancer drugs: a comparison of first and subsequent approvals.","volume":"7","author":"Lammers","year":"2017","journal-title":"Blood Cancer J"},{"key":"zoi220470r11","unstructured":"US Food and Drug Administration. Drugs@FDA: FDA-approved drugs. Accessed June 14, 2021. https:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/"},{"key":"zoi220470r12","unstructured":"European Medicines Agency. Covid-19 pandemic. Accessed June 14, 2021. https:\/\/www.ema.europa.eu\/en"},{"key":"zoi220470r18","unstructured":"Industry ARC. Oncology market research report: market size, industry outlook, market forecast, demand analysis, market share, market report 2021-2026. Accessed June 14, 2021. https:\/\/www.industryarc.com\/Report\/18335\/oncology-market.html"}],"container-title":["JAMA Network Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/articlepdf\/2793227\/lythgoe_2022_oi_220470_1654263494.61488.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,6,10]],"date-time":"2022-06-10T11:35:30Z","timestamp":1654860930000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/fullarticle\/2793227"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,6,10]]},"references-count":26,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2022,6,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamanetworkopen.2022.16183","relation":{},"ISSN":["2574-3805"],"issn-type":[{"value":"2574-3805","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,6,10]]}}}