{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T23:33:43Z","timestamp":1784676823646,"version":"3.55.0"},"reference-count":27,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2022,9,9]],"date-time":"2022-09-09T00:00:00Z","timestamp":1662681600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","award":["grant number R18FD005292, cooperative agreement U1"],"award-info":[{"award-number":["grant number R18FD005292, cooperative agreement U1"]}],"id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Clinical Trials Transformation Initiative"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clinical Trials"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:p>Master protocol studies typically use an overarching protocol to answer several questions by guiding a variety of sub-studies. These sub-studies can incorporate multiple diseases, therapies, or both. Although this innovative approach offers many benefits, including the ability to deliver clinical research that is more patient-centric and efficient, several common barriers curtail widespread adoption. The Clinical Trials Transformation Initiative (CTTI) convened industry representatives, regulatory agencies, patient groups, and academic institutions to identify emerging best practices and develop resources designed to help sponsors and other stakeholders overcome these challenges. We first identify some broad changes needed in the clinical trials ecosystem to facilitate mainstream adoption of master protocol studies, and we subsequently summarize CTTI\u2019s resources designed to support this effort.<\/jats:p>","DOI":"10.1177\/17407745221110199","type":"journal-article","created":{"date-parts":[[2022,9,10]],"date-time":"2022-09-10T01:23:41Z","timestamp":1662773021000},"page":"690-696","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["Mobilizing the clinical trial ecosystem to drive adoption of master protocols"],"prefix":"10.1177","volume":"19","author":[{"given":"Abby","family":"Bronson","sequence":"first","affiliation":[{"name":"Parent Project Muscular Dystrophy, Washington, DC, USA"},{"name":"Edgewise Therapeutics, Boulder, CO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marianne K","family":"Chase","sequence":"additional","affiliation":[{"name":"Sean M. Healey & AMG Center, Department of Neurology, Massachusetts General Hospital, Boston, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly","family":"Fisher","sequence":"additional","affiliation":[{"name":"Janssen R&D, LLC, Raritan, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Millar","sequence":"additional","affiliation":[{"name":"Janssen R&D, LLC, Raritan, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane","family":"Perlmutter","sequence":"additional","affiliation":[{"name":"Patient Advocate, Gemini Group, Ann Arbor, MI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9378-9909","authenticated-orcid":false,"given":"Nicholas","family":"Richardson","sequence":"additional","affiliation":[{"name":"Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2022,9,9]]},"reference":[{"key":"bibr1-17407745221110199","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1510062"},{"key":"bibr2-17407745221110199","unstructured":"U.S Food and Drug Administration. FDA in brief: FDA provides guidance on master protocols for evaluating prevention, treatment options for COVID-19, https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-brief-fda-provides-guidance-master-protocols-evaluating-prevention-treatment-options-covid-19 (2021, accessed 16 March 2022)."},{"key":"bibr3-17407745221110199","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-17-0764"},{"key":"bibr4-17407745221110199","unstructured":"I-SPY. The I-SPY trials, https:\/\/www.ispytrials.org\/ (accessed 16 March 2022)."},{"key":"bibr5-17407745221110199","doi-asserted-by":"publisher","DOI":"10.1002\/ana.26285"},{"key":"bibr6-17407745221110199","unstructured":"Reitsma D, Song R, Buhler K, et al. How to address\u2014and overcome\u2014operational challenges in master protocol studies. Applied Clinical Trials, https:\/\/www.appliedclinicaltrialsonline.com\/view\/how-to-address-and-overcome-operational-challenges-in-master-protocol-studies (2021, accessed 16 March 2022)."},{"key":"bibr7-17407745221110199","unstructured":"Clinical Trials Transformation Initiative. Master protocol studies, https:\/\/www.ctti-clinicaltrials.org\/projects\/master-protocol-studies (2020, accessed 16 March 2022)."},{"key":"bibr8-17407745221110199","unstructured":"Tenaerts P, Woodcock J, Califf RM, et al. The fastest path to effective COVID-19 treatments: using master protocol studies. Master Protocol Public Summit, https:\/\/ctti-clinicaltrials.org\/the-fastest-path-to-effective-covid-19-treatments-using-master-protocol-studies\/ (2021, accessed 16 March 2022)."},{"key":"bibr9-17407745221110199","unstructured":"Passut C. COVID-19 highlighted master protocol benefits, but challenges remain. CenterWatch RSS, https:\/\/www.centerwatch.com\/articles\/25472-covid-19-highlighted-master-protocol-benefits-but-challenges-remain (2021, accessed 16 March 2022)."},{"key":"bibr10-17407745221110199","doi-asserted-by":"publisher","DOI":"10.1038\/d41573-021-00037-3"},{"key":"bibr11-17407745221110199","unstructured":"National Institutes of Health. Accelerating COVID-19 therapeutic interventions and vaccines (ACTIV), https:\/\/www.nih.gov\/research-training\/medical-research-initiatives\/activ (2020, accessed 16 March 2022)."},{"key":"bibr12-17407745221110199","unstructured":"U.S. Department of Health and Human Services, Food and Drug Administration; Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research. Pregnant women: scientific and ethical considerations for inclusion in clinical trials guidance for industry, https:\/\/www.fda.gov\/media\/112195\/download (2018, accessed 16 March 2022)."},{"key":"bibr13-17407745221110199","doi-asserted-by":"publisher","DOI":"10.1177\/2168479018774533"},{"key":"bibr14-17407745221110199","unstructured":"Lung-MAP Trial, https:\/\/www.lung-map.org\/ (accessed 16 March 2022)."},{"key":"bibr15-17407745221110199","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djz245"},{"key":"bibr16-17407745221110199","unstructured":"Clinical Trials Transformation Initiative. CTTI recommendations on effective engagement with patient groups around clinical trials, https:\/\/ctti-clinicaltrials.org\/wp-content\/uploads\/2021\/06\/CTTI_Patient_Group_Engagement_Recs.pdf (2020, accessed 16 March 2022)."},{"key":"bibr17-17407745221110199","unstructured":"ICH. 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