{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T04:09:01Z","timestamp":1793938141833,"version":"4.8.0"},"reference-count":30,"publisher":"American Medical Association (AMA)","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Oncol"],"published-print":{"date-parts":[[2021,5,1]]},"DOI":"10.1001\/jamaoncol.2021.0379","type":"journal-article","created":{"date-parts":[[2021,3,25]],"date-time":"2021-03-25T12:48:39Z","timestamp":1616676519000},"page":"728","source":"Crossref","is-referenced-by-count":196,"title":["Evolution of the Randomized Clinical Trial in the Era of Precision Oncology"],"prefix":"10.1001","volume":"7","author":[{"given":"Joseph C.","family":"Del Paggio","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Thunder Bay Regional Health Sciences Centre and Northern Ontario School of Medicine, Thunder Bay, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John S.","family":"Berry","sequence":"additional","affiliation":[{"name":"Division of Cancer Care and Epidemiology, Queen\u2019s Cancer Research Institute, Queen\u2019s University, Kingston, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wilma M.","family":"Hopman","sequence":"additional","affiliation":[{"name":"Kingston General Health Research Institute, Kingston, Canada"},{"name":"Department of Public Health Sciences, Queen\u2019s University, Kingston, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth A.","family":"Eisenhauer","sequence":"additional","affiliation":[{"name":"Department of Oncology, Queen\u2019s University, Kingston, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vinay","family":"Prasad","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Biostatistics, University of California at San Francisco"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bishal","family":"Gyawali","sequence":"additional","affiliation":[{"name":"Division of Cancer Care and Epidemiology, Queen\u2019s Cancer Research Institute, Queen\u2019s University, Kingston, Canada"},{"name":"Department of Public Health Sciences, Queen\u2019s University, Kingston, Canada"},{"name":"Department of Oncology, Queen\u2019s University, Kingston, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher M.","family":"Booth","sequence":"additional","affiliation":[{"name":"Division of Cancer Care and Epidemiology, Queen\u2019s Cancer Research Institute, Queen\u2019s University, Kingston, Canada"},{"name":"Department of Public Health Sciences, Queen\u2019s University, Kingston, Canada"},{"name":"Department of Oncology, Queen\u2019s University, Kingston, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","reference":[{"issue":"33","key":"coi210005r1","doi-asserted-by":"publisher","first-page":"5458","DOI":"10.1200\/JCO.2008.16.5456","article-title":"Evolution of the randomized controlled trial in oncology over three decades.","volume":"26","author":"Booth","year":"2008","journal-title":"J Clin Oncol"},{"issue":"6","key":"coi210005r2","doi-asserted-by":"publisher","first-page":"1646","DOI":"10.1093\/annonc\/mdr492","article-title":"Randomized controlled trials in the era of molecular oncology: methodology, biomarkers, and end points.","volume":"23","author":"Kay","year":"2012","journal-title":"Ann Oncol"},{"issue":"8","key":"coi210005r3","doi-asserted-by":"publisher","first-page":"711","DOI":"10.1056\/NEJMoa1003466","article-title":"Improved survival with ipilimumab in patients with metastatic melanoma.","volume":"363","author":"Hodi","year":"2010","journal-title":"N Engl J Med"},{"issue":"7","key":"coi210005r4","doi-asserted-by":"publisher","first-page":"1411","DOI":"10.1093\/annonc\/mdp552","article-title":"Absolute benefits of medical therapies in phase III clinical trials for breast and colorectal cancer.","volume":"21","author":"Seruga","year":"2010","journal-title":"Ann Oncol"},{"issue":"9","key":"coi210005r5","doi-asserted-by":"publisher","first-page":"1238","DOI":"10.1001\/jamaoncol.2016.0931","article-title":"An appraisal of clinically meaningful outcomes guidelines for oncology clinical trials.","volume":"2","author":"Kumar","year":"2016","journal-title":"JAMA Oncol"},{"issue":"2","key":"coi210005r6","doi-asserted-by":"publisher","first-page":"174","DOI":"10.1200\/JCO.2010.31.9624","article-title":"Reporting of serious adverse drug reactions of targeted anticancer agents in pivotal phase III clinical trials.","volume":"29","author":"Seruga","year":"2011","journal-title":"J Clin Oncol"},{"issue":"4","key":"coi210005r7","doi-asserted-by":"publisher","first-page":"e208","DOI":"10.1200\/JOP.2013.001351","article-title":"High cancer drug prices in the United States: reasons and proposed solutions.","volume":"10","author":"Kantarjian","year":"2014","journal-title":"J Oncol Pract"},{"issue":"3","key":"coi210005r8","doi-asserted-by":"publisher","first-page":"135","DOI":"10.1038\/nrclinonc.2017.18","article-title":"Approvals in 2016: questioning the clinical benefit of anticancer therapies.","volume":"14","author":"Booth","year":"2017","journal-title":"Nat Rev Clin Oncol"},{"issue":"8","key":"coi210005r9","doi-asserted-by":"publisher","first-page":"1547","DOI":"10.1093\/annonc\/mdv249","article-title":"A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).","volume":"26","author":"Cherny","year":"2015","journal-title":"Ann Oncol"},{"issue":"23","key":"coi210005r10","doi-asserted-by":"publisher","first-page":"2563","DOI":"10.1200\/JCO.2015.61.6706","article-title":"American Society of Clinical Oncology statement: a conceptual framework to assess the value of cancer treatment options.","volume":"33","author":"Schnipper","year":"2015","journal-title":"J Clin Oncol"},{"issue":"12","key":"coi210005r11","doi-asserted-by":"publisher","first-page":"1225","DOI":"10.1001\/jamaoto.2014.1570","article-title":"Unintended consequences of expensive cancer therapeutics\u2014the pursuit of marginal indications and a me-too mentality that stifles innovation and creativity: the John Conley Lecture.","volume":"140","author":"Fojo","year":"2014","journal-title":"JAMA Otolaryngol Head Neck Surg"},{"issue":"5","key":"coi210005r12","doi-asserted-by":"publisher","first-page":"1111","DOI":"10.1093\/annonc\/mdx053","article-title":"Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000-2015.","volume":"28","author":"Vivot","year":"2017","journal-title":"Ann Oncol"},{"issue":"5","key":"coi210005r13","doi-asserted-by":"publisher","first-page":"486","DOI":"10.1093\/jnci\/djx232","article-title":"Magnitude of clinical benefit of cancer drugs approved by the US Food and Drug Administration.","volume":"110","author":"Tibau","year":"2018","journal-title":"J Natl Cancer Inst"},{"key":"coi210005r14","doi-asserted-by":"publisher","first-page":"j4530","DOI":"10.1136\/bmj.j4530","article-title":"Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13.","volume":"359","author":"Davis","year":"2017","journal-title":"BMJ"},{"issue":"1","key":"coi210005r15","doi-asserted-by":"publisher","first-page":"157","DOI":"10.1093\/annonc\/mdw538","article-title":"Do contemporary randomized controlled trials meet ESMO thresholds for meaningful clinical benefit?","volume":"28","author":"Del Paggio","year":"2017","journal-title":"Ann Oncol"},{"issue":"7","key":"coi210005r16","doi-asserted-by":"publisher","first-page":"887","DOI":"10.1016\/S1470-2045(17)30415-1","article-title":"Delivery of meaningful cancer care: a retrospective cohort study assessing cost and benefit with the ASCO and ESMO frameworks.","volume":"18","author":"Del Paggio","year":"2017","journal-title":"Lancet Oncol"},{"issue":"10","key":"coi210005r17","doi-asserted-by":"publisher","first-page":"1030","DOI":"10.1200\/JCO.2011.38.7571","article-title":"Progression-free survival: meaningful or simply measurable?","volume":"30","author":"Booth","year":"2012","journal-title":"J Clin Oncol"},{"issue":"8","key":"coi210005r18","doi-asserted-by":"publisher","first-page":"1389","DOI":"10.1001\/jamainternmed.2015.2829","article-title":"The strength of association between surrogate end points and survival in oncology: a systematic review of trial-level meta-analyses.","volume":"175","author":"Prasad","year":"2015","journal-title":"JAMA Intern Med"},{"issue":"12","key":"coi210005r19","doi-asserted-by":"publisher","first-page":"1586","DOI":"10.1001\/jamainternmed.2018.4710","article-title":"Evaluating progression-free survival as a surrogate outcome for health-related quality of life in oncology: a systematic review and quantitative analysis.","volume":"178","author":"Kovic","year":"2018","journal-title":"JAMA Intern Med"},{"issue":"7","key":"coi210005r20","doi-asserted-by":"publisher","first-page":"1746","DOI":"10.1002\/ijc.v144.7","article-title":"Association between progression-free survival and patients\u2019 quality of life in cancer clinical trials.","volume":"144","author":"Hwang","year":"2019","journal-title":"Int J Cancer"},{"key":"coi210005r21","article-title":"Use of next-generation sequencing tests to guide cancer treatment: results from a nationally representative survey of oncologists in the United States.","volume":"2","author":"Freedman","year":"2018","journal-title":"JCO Precis Oncol"},{"key":"coi210005r22","doi-asserted-by":"publisher","first-page":"20","DOI":"10.1016\/j.ctrv.2018.12.003","article-title":"New clinical trial designs in the era of precision medicine: an overview of definitions, strengths, weaknesses, and current use in oncology.","volume":"73","author":"Janiaud","year":"2019","journal-title":"Cancer Treat Rev"},{"issue":"9230","key":"coi210005r23","doi-asserted-by":"publisher","first-page":"635","DOI":"10.1016\/S0140-6736(00)02605-2","article-title":"The uncertainty principle and industry-sponsored research.","volume":"356","author":"Djulbegovic","year":"2000","journal-title":"Lancet"},{"key":"coi210005r24","doi-asserted-by":"publisher","first-page":"71","DOI":"10.1016\/j.ejca.2016.11.005","article-title":"Impact of industry collaboration on randomised controlled trials in oncology.","volume":"72","author":"Linker","year":"2017","journal-title":"Eur J Cancer"},{"issue":"10","key":"coi210005r25","doi-asserted-by":"publisher","first-page":"2129","DOI":"10.1093\/annonc\/mdy305","article-title":"Role of industry funders in oncology RCTs published in high-impact journals and its association with trial conclusions and time to publication.","volume":"29","author":"Liang","year":"2018","journal-title":"Ann Oncol"},{"issue":"10","key":"coi210005r26","doi-asserted-by":"publisher","first-page":"1625","DOI":"10.1001\/jamaoncol.2020.1284","article-title":"Association of industry sponsorship with cancer clinical trial accrual.","volume":"6","author":"Pasalic","year":"2020","journal-title":"JAMA Oncol"},{"key":"coi210005r27","article-title":"An analysis of contemporary oncology randomized clinical trials from low\/middle-income vs high-income countries.","author":"Wells","journal-title":"JAMA Oncol"},{"issue":"11","key":"coi210005r28","doi-asserted-by":"publisher","first-page":"e1812","DOI":"10.1634\/theoncologist.2020-0406","article-title":"Professional medical writer assistance in oncology clinical trials.","volume":"25","author":"Kouzy","year":"2020","journal-title":"Oncologist"},{"key":"coi210005r29","article-title":"Have investigators forgotten how to write?","author":"Tannock","journal-title":"Ann Oncol"},{"issue":"10","key":"coi210005r30","doi-asserted-by":"publisher","first-page":"971","DOI":"10.1056\/NEJMra1601511","article-title":"The primary outcome is positive\u2014is that good enough?","volume":"375","author":"Pocock","year":"2016","journal-title":"N Engl J Med"}],"container-title":["JAMA Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamaoncology\/articlepdf\/2777587\/jamaoncology_del_paggio_2021_oi_210005_1621004954.04238.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,5,20]],"date-time":"2021-05-20T11:08:11Z","timestamp":1621508891000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamaoncology\/fullarticle\/2777587"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,5,1]]},"references-count":30,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2021,5,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamaoncol.2021.0379","relation":{},"ISSN":["2374-2437"],"issn-type":[{"value":"2374-2437","type":"print"}],"subject":[],"published":{"date-parts":[[2021,5,1]]}}}