{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T15:45:29Z","timestamp":1792079129566,"version":"4.4.0"},"reference-count":53,"publisher":"American Medical Association (AMA)","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Oncol"],"published-print":{"date-parts":[[2026,10,1]]},"abstract":"\n Importance<\/jats:title>\n Industry and federal sponsors support much of the US cancer clinical trial enterprise. Industry-sponsored trials have traditionally focused on therapeutic development and regulatory approval, whereas federally sponsored trials have been viewed as addressing broader clinical and public health research questions. However, differences between these trial portfolios have not been systematically quantified.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To characterize differences between federally sponsored and industry-sponsored cancer clinical trials in the US.<\/jats:p>\n <\/jats:sec>\n \n Design and Setting<\/jats:title>\n A comparative study of interventional cancer clinical trial portfolios registered on ClinicalTrials.gov and initiated between 2008 and 2024. US-based interventional cancer trials, including treatment and nontreatment interventions, were included.<\/jats:p>\n <\/jats:sec>\n \n Exposure<\/jats:title>\n Lead sponsor classified as federal or industry.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n \n Trial characteristics, including study purpose, phase, intervention type, deescalation design, rare cancer focus, and patient age category (adult vs children). Differences in trial characteristics by sponsor type were assessed using \u03c7\n 2<\/jats:sup>\n tests and described using odds ratios (ORs) with 95% CIs.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Overall, 11\u202f681 federally sponsored trials (n\u2009=\u20092112 [18.1%]) and industry-sponsored trials (n\u2009=\u20099569 [81.9%]) were analyzed. Compared with industry-sponsored trials, federally sponsored trials were less likely to be single-agent drug trials conducted for the purpose of cancer treatment (48.6% vs 77.4%; OR,\u20090.28; 95% CI, 0.25-0.31;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). In contrast, federally sponsored trials were more likely to evaluate nontreatment interventional trials, including prevention (4.7% vs 1.1%; OR,\u20094.43; 95% CI, 3.32-5.92;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001) and supportive care (2.5% vs 0.9%; OR,\u20092.92; 95% CI, 2.02-4.20;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). Among trials conducted for the purpose of cancer treatment, federally sponsored studies were more likely to investigate multimodality regimens combining drug and biological agents (19.1% vs 7.4%; OR,\u20092.98; 95% CI, 2.58-3.44;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001) and to combine drug and\/or biological agent regimens with radiotherapy (10.5% vs 1.4%; OR,\u20098.22; 95% CI, 6.51-10.37;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001) or surgery (2.5% vs 0.2%; OR,\u200914.09; 95% CI, 7.95-24.98;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). Federal sponsorship was also associated with greater use of deescalation trial designs (3.1% vs 0.4%; OR,\u20098.38; 95% CI, 5.43-12.94;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001) and trials conducted in rare cancers (17.5% vs 12.1%; OR, 1.54; 95% CI, 1.34-1.77;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001) and in children (16.1% vs 5.3%; OR, 3.43; 95% CI, 2.93-4.01;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n In this study, industry-sponsored trials were more likely to evaluate single-agent drug therapies, whereas US federally sponsored trials were more likely to evaluate nontreatment interventions, multimodality treatment strategies, treatment deescalation approaches, and therapies for rare cancers and pediatric populations. These findings provide an empirical characterization of the complementary and essential roles of federal and industry sponsors in the cancer clinical trial enterprise.<\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamaoncol.2026.3026","type":"journal-article","created":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T15:00:31Z","timestamp":1787238031000},"page":"1118","source":"Crossref","is-referenced-by-count":1,"title":["Federal and Industry Sponsorship in US Cancer Clinical Trials"],"prefix":"10.1001","volume":"12","author":[{"given":"Joseph M.","family":"Unger","sequence":"first","affiliation":[{"name":"Fred Hutchinson Cancer Center, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hong","family":"Xiao","sequence":"additional","affiliation":[{"name":"Fred Hutchinson Cancer Center, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael L.","family":"LeBlanc","sequence":"additional","affiliation":[{"name":"Fred Hutchinson Cancer Center, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dawn L.","family":"Hershman","sequence":"additional","affiliation":[{"name":"Columbia University Irving Medical Center, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","reference":[{"issue":"10","key":"coi260046r1","doi-asserted-by":"publisher","first-page":"897","DOI":"10.1056\/NEJMp2007839","article-title":"Progress in cancer research, prevention, and care.","volume":"383","author":"Schilsky","year":"2020","journal-title":"N Engl J Med"},{"issue":"1","key":"coi260046r2","first-page":"10","article-title":"Cancer statistics, 2025.","volume":"75","author":"Siegel","year":"2025","journal-title":"CA Cancer J Clin"},{"key":"coi260046r3","doi-asserted-by":"publisher","first-page":"185","DOI":"10.1200\/EDBK_156686","article-title":"The role of clinical trial participation in cancer research: barriers, evidence, and strategies.","volume":"35","author":"Unger","year":"2016","journal-title":"Am Soc Clin Oncol Educ Book"},{"issue":"4","key":"coi260046r7","doi-asserted-by":"publisher","first-page":"368","DOI":"10.1001\/jama.2013.282034","article-title":"Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.","volume":"311","author":"Downing","year":"2014","journal-title":"JAMA"},{"issue":"11","key":"coi260046r8","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.24406","article-title":"Clinical trial evidence supporting US Food and Drug Administration approval of novel cancer therapies between 2000 and 2016.","volume":"3","author":"Ladanie","year":"2020","journal-title":"JAMA Netw Open"},{"issue":"8","key":"coi260046r9","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.14682","article-title":"Assessment of trends in the design, accrual, and completion of trials registered in clinicaltrials.gov by sponsor type, 2000-2019.","volume":"3","author":"Gresham","year":"2020","journal-title":"JAMA Netw Open"},{"issue":"33","key":"coi260046r10","doi-asserted-by":"publisher","first-page":"3887","DOI":"10.1200\/JCO-24-01484","article-title":"Bridging the gap in cancer clinical trial funding.","volume":"42","author":"Abdou","year":"2024","journal-title":"J Clin Oncol"},{"issue":"3","key":"coi260046r11","doi-asserted-by":"publisher","first-page":"212","DOI":"10.3322\/caac.21273","article-title":"Improving the outcome for children with cancer: development of targeted new agents.","volume":"65","author":"Adamson","year":"2015","journal-title":"CA Cancer J Clin"},{"issue":"2","key":"coi260046r12","doi-asserted-by":"publisher","DOI":"10.1136\/esmoopen-2019-000666","article-title":"Rationale of the rare cancer list: a consensus paper from the Joint Action on Rare Cancers (JARC) of the European Union (EU).","volume":"5","author":"Casali","year":"2020","journal-title":"ESMO Open"},{"issue":"23","key":"coi260046r13","doi-asserted-by":"publisher","first-page":"5008","DOI":"10.1002\/cncr.33210","article-title":"The National Clinical Trials Network and the cooperative groups: the road not taken.","volume":"126","author":"Schilsky","year":"2020","journal-title":"Cancer"},{"issue":"33","key":"coi260046r14","doi-asserted-by":"publisher","first-page":"3917","DOI":"10.1200\/JCO.24.00843","article-title":"Patient enrollment to industry-sponsored versus federally-sponsored cancer clinical trials.","volume":"42","author":"Unger","year":"2024","journal-title":"J Clin Oncol"},{"issue":"9","key":"coi260046r16","doi-asserted-by":"publisher","first-page":"852","DOI":"10.1056\/NEJMsa1012065","article-title":"The ClinicalTrials.gov results database\u2014update and key issues.","volume":"364","author":"Zarin","year":"2011","journal-title":"N Engl J Med"},{"issue":"17","key":"coi260046r17","doi-asserted-by":"publisher","first-page":"1838","DOI":"10.1001\/jama.2012.3424","article-title":"Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010.","volume":"307","author":"Califf","year":"2012","journal-title":"JAMA"},{"issue":"1","key":"coi260046r19","doi-asserted-by":"publisher","first-page":"858","DOI":"10.1186\/s13063-022-06569-2","article-title":"Update on the clinical trial landscape: analysis of ClinicalTrials.gov registration data, 2000-2020.","volume":"23","author":"Gresham","year":"2022","journal-title":"Trials"},{"issue":"13","key":"coi260046r20","doi-asserted-by":"publisher","first-page":"4495","DOI":"10.1002\/cam4.3083","article-title":"Sponsorship of oncology clinical trials in the United States according to age of eligibility.","volume":"9","author":"Neel","year":"2020","journal-title":"Cancer Med"},{"issue":"1","key":"coi260046r21","doi-asserted-by":"publisher","DOI":"10.1017\/cts.2024.599","article-title":"Phase I clinical trial designs in oncology: a systematic literature review from 2020 to 2022.","volume":"8","author":"Li","year":"2024","journal-title":"J Clin Transl Sci"},{"issue":"23","key":"coi260046r23","doi-asserted-by":"publisher","first-page":"6925","DOI":"10.1158\/1078-0432.CCR-19-1754","article-title":"Transforming the early drug development paradigm at the National Cancer Institute: the formation of NCI\u2019s Experimental Therapeutics Clinical Trials Network (ETCTN).","volume":"25","author":"Massett","year":"2019","journal-title":"Clin Cancer Res"},{"issue":"23","key":"coi260046r24","doi-asserted-by":"publisher","first-page":"4728","DOI":"10.1158\/1078-0432.CCR-23-0917","article-title":"The New NCI precision medicine trials.","volume":"29","author":"Harris","year":"2023","journal-title":"Clin Cancer Res"},{"issue":"10","key":"coi260046r25","doi-asserted-by":"publisher","first-page":"2290","DOI":"10.1158\/1078-0432.CCR-19-3356","article-title":"A Phase II basket trial of dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART SWOG 1609) in patients with nonpancreatic neuroendocrine tumors.","volume":"26","author":"Patel","year":"2020","journal-title":"Clin Cancer Res"},{"issue":"10","key":"coi260046r26","doi-asserted-by":"publisher","first-page":"2329","DOI":"10.1073\/pnas.1715368115","article-title":"Contribution of NIH funding to new drug approvals 2010-2016.","volume":"115","author":"Galkina Cleary","year":"2018","journal-title":"Proc Natl Acad Sci U S A"},{"issue":"7","key":"coi260046r27","doi-asserted-by":"publisher","first-page":"640","DOI":"10.1056\/NEJMoa1000067","article-title":"Reduced treatment intensity in patients with early-stage Hodgkin\u2019s lymphoma.","volume":"363","author":"Engert","year":"2010","journal-title":"N Engl J Med"},{"issue":"19","key":"coi260046r28","doi-asserted-by":"publisher","first-page":"1916","DOI":"10.1056\/NEJMoa064601","article-title":"Chemotherapy plus involved-field radiation in early-stage Hodgkin\u2019s disease.","volume":"357","author":"Ferm\u00e9","year":"2007","journal-title":"N Engl J Med"},{"issue":"16","key":"coi260046r29","doi-asserted-by":"publisher","first-page":"1233","DOI":"10.1056\/NEJMoa022152","article-title":"Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer.","volume":"347","author":"Fisher","year":"2002","journal-title":"N Engl J Med"},{"issue":"6","key":"coi260046r30","doi-asserted-by":"publisher","first-page":"352","DOI":"10.1056\/NEJM199002083220602","article-title":"Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma.","volume":"322","author":"Moertel","year":"1990","journal-title":"N Engl J Med"},{"issue":"25","key":"coi260046r31","doi-asserted-by":"publisher","first-page":"2336","DOI":"10.1056\/NEJMoa2108873","article-title":"21-Gene assay to inform chemotherapy benefit in node-positive breast cancer.","volume":"385","author":"Kalinsky","year":"2021","journal-title":"N Engl J Med"},{"issue":"2","key":"coi260046r32","doi-asserted-by":"publisher","first-page":"111","DOI":"10.1056\/NEJMoa1804710","article-title":"Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer.","volume":"379","author":"Sparano","year":"2018","journal-title":"N Engl J Med"},{"issue":"4","key":"coi260046r33","doi-asserted-by":"publisher","first-page":"322","DOI":"10.1056\/NEJMoa2303269","article-title":"Preoperative treatment of locally advanced rectal cancer.","volume":"389","author":"Schrag","year":"2023","journal-title":"N Engl J Med"},{"key":"coi260046r34","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2026.04.004","article-title":"DART (NCI\/SWOG S1609): comprehensive final results from dual checkpoint inhibition with CTLA-4 and PD-1 blockade in rare cancers.","author":"Patel","year":"2026","journal-title":"Ann Oncol"},{"issue":"33","key":"coi260046r35","doi-asserted-by":"publisher","first-page":"3883","DOI":"10.1200\/JCO.19.03010","article-title":"Molecular landscape and actionable alterations in a genomically guided cancer clinical trial: National Cancer Institute Molecular Analysis for Therapy Choice (NCI-MATCH).","volume":"38","author":"Flaherty","year":"2020","journal-title":"J Clin Oncol"},{"issue":"4","key":"coi260046r36","doi-asserted-by":"publisher","first-page":"626","DOI":"10.1200\/JCO.2007.13.4452","article-title":"Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033.","volume":"26","author":"Blanke","year":"2008","journal-title":"J Clin Oncol"},{"issue":"6","key":"coi260046r37","doi-asserted-by":"publisher","first-page":"1349","DOI":"10.1038\/s41591-023-02379-4","article-title":"The NCI-MATCH trial: lessons for precision oncology.","volume":"29","author":"O\u2019Dwyer","year":"2023","journal-title":"Nat Med"},{"issue":"6","key":"coi260046r38","doi-asserted-by":"publisher","first-page":"1066","DOI":"10.1200\/JCO.2003.11.138","article-title":"Regulatory approvals of pediatric oncology drugs: previous experience and new initiatives.","volume":"21","author":"Hirschfeld","year":"2003","journal-title":"J Clin Oncol"},{"issue":"12","key":"coi260046r39","doi-asserted-by":"publisher","first-page":"3091","DOI":"10.1200\/JCO.2001.19.12.3091","article-title":"Intergroup Rhabdomyosarcoma Study-IV: results for patients with nonmetastatic disease.","volume":"19","author":"Crist","year":"2001","journal-title":"J Clin Oncol"},{"issue":"16","key":"coi260046r40","doi-asserted-by":"publisher","first-page":"1541","DOI":"10.1056\/NEJMra1400972","article-title":"Acute lymphoblastic leukemia in children.","volume":"373","author":"Hunger","year":"2015","journal-title":"N Engl J Med"},{"issue":"26","key":"coi260046r41","doi-asserted-by":"publisher","first-page":"2730","DOI":"10.1056\/NEJMoa0900386","article-title":"Treating childhood acute lymphoblastic leukemia without cranial irradiation.","volume":"360","author":"Pui","year":"2009","journal-title":"N Engl J Med"},{"issue":"7","key":"coi260046r42","doi-asserted-by":"publisher","first-page":"875","DOI":"10.1001\/jamaoncol.2015.6487","article-title":"The scientific impact of positive and negative phase 3 cancer clinical trials.","volume":"2","author":"Unger","year":"2016","journal-title":"JAMA Oncol"},{"issue":"4","key":"coi260046r43","doi-asserted-by":"publisher","DOI":"10.1093\/jncics\/pkaa034","article-title":"Representativeness of Black patients in cancer clinical trials sponsored by the National Cancer Institute compared with pharmaceutical companies.","volume":"4","author":"Unger","year":"2020","journal-title":"J Natl Cancer Inst Cancer Spectr"},{"issue":"11","key":"coi260046r44","doi-asserted-by":"publisher","first-page":"2020","DOI":"10.1200\/JCO.22.01826","article-title":"Population, clinical, and scientific impact of National Cancer Institute\u2019s National Clinical Trials Network treatment studies.","volume":"41","author":"Unger","year":"2023","journal-title":"J Clin Oncol"},{"issue":"9","key":"coi260046r45","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2019.10593","article-title":"Association of National Cancer Institute-sponsored Clinical Trial Network group studies with guideline care and new drug indications.","volume":"2","author":"Unger","year":"2019","journal-title":"JAMA Netw Open"},{"issue":"1","key":"coi260046r46","doi-asserted-by":"publisher","first-page":"105","DOI":"10.4103\/jfmpc.jfmpc_578_19","article-title":"Trends in FDA drug approvals over last 2 decades: an observational study.","volume":"9","author":"Batta","year":"2020","journal-title":"J Family Med Prim Care"},{"issue":"5","key":"coi260046r47","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":"7","key":"coi260046r48","doi-asserted-by":"publisher","first-page":"640","DOI":"10.1056\/NEJMoa1916623","article-title":"The effect of advances in lung-cancer treatment on population mortality.","volume":"383","author":"Howlader","year":"2020","journal-title":"N Engl J Med"},{"issue":"18","key":"coi260046r52","doi-asserted-by":"publisher","first-page":"2139","DOI":"10.1200\/JCO.23.01030","article-title":"National estimates of the participation of patients with cancer in clinical research studies based on Commission on Cancer accreditation data.","volume":"42","author":"Unger","year":"2024","journal-title":"J Clin Oncol"},{"issue":"10","key":"coi260046r53","doi-asserted-by":"publisher","first-page":"134","DOI":"10.1200\/OP.2025.21.10_suppl.134","article-title":"Charting the geographic footprint of federally funded cancer treatment trials: an ASCO State of Cancer Care in America analysis.","volume":"21","author":"Kirkwood","year":"2025","journal-title":"JCO Oncol Pract"},{"key":"coi260046r6","volume-title":"A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program","author":"Institute of Medicine","year":"2010"},{"key":"coi260046r49"},{"key":"coi260046r51","volume-title":"Extending Medicare Reimbursement in Clinical Trials","author":"Institute of Medicine","year":"2000"},{"key":"coi260046r4","unstructured":"US Food and Drug Administration. Demonstrating substantial evidence of effectiveness for human drug and biological products: guidance for industry. Silver Spring, MD: US Department of Health and Human Services, January 2020. Accessed November 17, 2025. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/demonstrating-substantial-evidence-effectiveness-human-drug-and-biological-products"},{"key":"coi260046r5","unstructured":"National Comprehensive Cancer Network (NCCN). Development and update of guidelines. Accessed October 26, 2025. https:\/\/www.nccn.org\/guidelines\/guidelines-process\/development-and-update-of-guidelines"},{"key":"coi260046r15","unstructured":"Food and Drug Administration Amendments Act of 2007. 110th Congress (2007). Pub Law No. 110-85. Accessed December 3, 2025. https:\/\/www.govinfo.gov\/content\/pkg\/PLAW-110publ85\/pdf\/PLAW-110publ85.pdf"},{"key":"coi260046r18","unstructured":"ClinicalTrials.gov. Study data structure. Accessed October 27, 2025. https:\/\/clinicaltrials.gov\/data-api\/about-api\/study-data-structure."},{"key":"coi260046r22","unstructured":"National Cancer Institute, Division of Cancer Treatment & Diagnosis. ETCTN: NCI\u2019s Experimental Therapeutics Clinical Trials Network. Accessed October 30, 2025. https:\/\/dctd.cancer.gov\/research\/networks\/etctn"},{"key":"coi260046r50","unstructured":"National Institutes of Health. Cooperative Research and Development Agreements (CRADAs). Office of Technology Transfer. Accessed March 15, 2026. https:\/\/www.techtransfer.nih.gov\/partnerships\/cradas"}],"container-title":["JAMA Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamaoncology\/articlepdf\/2853216\/jamaoncology_unger_2026_oi_260046_1792007355.62371.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T15:00:48Z","timestamp":1792076448000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamaoncology\/fullarticle\/2853216"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,1]]},"references-count":53,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2026,10,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamaoncol.2026.3026","relation":{},"ISSN":["2374-2437"],"issn-type":[{"value":"2374-2437","type":"print"}],"subject":[],"published":{"date-parts":[[2026,10,1]]}}}