{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T13:30:38Z","timestamp":1787664638221,"version":"build-2736575974"},"reference-count":6,"publisher":"American Medical Association (AMA)","issue":"7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Intern Med"],"published-print":{"date-parts":[[2023,7,1]]},"abstract":"<jats:p>This cross-sectional study examines and compares the time taken from the accelerated approval of cancer and noncancer drugs to the initiation of confirmatory studies in the US.<\/jats:p>","DOI":"10.1001\/jamainternmed.2023.0777","type":"journal-article","created":{"date-parts":[[2023,5,22]],"date-time":"2023-05-22T15:33:27Z","timestamp":1684769607000},"page":"737","source":"Crossref","is-referenced-by-count":12,"title":["Time to Confirmatory Study Initiation After Accelerated Approval of Cancer and Noncancer Drugs in the US"],"prefix":"10.1001","volume":"183","author":[{"given":"Shelley A.","family":"Jazowski","sequence":"first","affiliation":[{"name":"Department of Health Policy, Vanderbilt University School of Medicine, Nashville, Tennessee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Avi U.","family":"Vaidya","sequence":"additional","affiliation":[{"name":"Department of Health Policy, Vanderbilt University School of Medicine, Nashville, Tennessee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie M.","family":"Donohue","sequence":"additional","affiliation":[{"name":"Department of Health Policy and Management, University of Pittsburgh School of Public Health, Pittsburgh, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stacie B.","family":"Dusetzina","sequence":"additional","affiliation":[{"name":"Department of Health Policy, Vanderbilt University School of Medicine, Nashville, Tennessee"},{"name":"Vanderbilt-Ingram Cancer Center, Nashville, Tennessee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel E.","family":"Sachs","sequence":"additional","affiliation":[{"name":"Washington University in St Louis School of Law, St Louis, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","reference":[{"issue":"16","key":"ild230007r1","doi-asserted-by":"publisher","first-page":"1439","DOI":"10.1056\/NEJMp2208954","article-title":"The on- and off-ramps of oncology accelerated approval.","volume":"387","author":"Fashoyin-Aje","year":"2022","journal-title":"N Engl J Med"},{"issue":"11","key":"ild230007r2","doi-asserted-by":"publisher","DOI":"10.1001\/jamahealthforum.2022.4115","article-title":"Reforming reimbursement for the US Food and Drug Administration\u2019s accelerated approval program to support state Medicaid programs.","volume":"3","author":"Sachs","year":"2022","journal-title":"JAMA Health Forum"},{"key":"ild230007r3","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.0625","article-title":"Association between preapproval confirmatory trial initiation and conversion to tradition approval or withdrawal in the FDA accelerated approval pathway.","author":"Shahzad","journal-title":"JAMA"},{"key":"ild230007r4","unstructured":"Consolidated Appropriations Act, 2023. 117 Cong, 2nd Sess (2022). Accessed January 24, 2023. https:\/\/www.congress.gov\/bill\/117th-congress\/house-bill\/2617\/text"},{"key":"ild230007r5","unstructured":"US Food and Drug Administration. CDER drug and biologic accelerated approvals based on a surrogate endpoint as of March 31, 2023: total approvals 295. Updated April 14, 2023. Accessed April 23, 2023. https:\/\/www.fda.gov\/media\/151146\/download"},{"key":"ild230007r6","unstructured":"US Food and Drug Administration. Drugs@FDA: FDA-approved drugs. Accessed April 23, 2023. https:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm"}],"container-title":["JAMA Internal Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamainternalmedicine\/articlepdf\/2804689\/jamainternal_jazowski_2023_ld_230007_1687982076.78004.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,7,3]],"date-time":"2023-07-03T15:13:22Z","timestamp":1688397202000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamainternalmedicine\/fullarticle\/2804689"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,7,1]]},"references-count":6,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2023,7,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamainternmed.2023.0777","relation":{},"ISSN":["2168-6106"],"issn-type":[{"value":"2168-6106","type":"print"}],"subject":[],"published":{"date-parts":[[2023,7,1]]}}}