{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T18:56:48Z","timestamp":1789757808345,"version":"4.0.1"},"reference-count":44,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2024,5,9]],"date-time":"2024-05-09T00:00:00Z","timestamp":1715212800000},"content-version":"vor","delay-in-days":12,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000289","name":"Cancer Research UK","doi-asserted-by":"publisher","award":["CRUK\/28301"],"award-info":[{"award-number":["CRUK\/28301"]}],"id":[{"id":"10.13039\/501100000289","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Astra Zeneca"},{"DOI":"10.13039\/501100000272","name":"National Institute for Health and Care Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]},{"name":"European Unio"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>The aim of this review was to highlight why the use of master protocols trial design is particularly useful for radiotherapy intervention trials where complex setup pathways (including quality assurance, user training, and integrating multiple modalities of treatment) may hinder clinical advances.<\/jats:p>\n               <jats:p>We carried out a systematic review according to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines, reviewing the findings using a landscape analysis. Results were summarized descriptively, reporting on trial characteristics highlighting the benefits, limitations, and challenges of developing and implementing radiotherapy master protocols, with three case studies selected to explore these issues in more detail.<\/jats:p>\n               <jats:p>Twelve studies were suitable for inclusion (4 platform trials, 3 umbrella trials, and 5 basket trials), evaluating a mix of solid tumor sites in both curative and palliative settings. The interventions were categorized into 1) novel agent and radiotherapy combinations; 2) radiotherapy dose personalization; and 3) device evaluation, with a case study provided for each intervention. Benefits of master protocol trials for radiotherapy intervention include protocol efficiency for implementation of novel radiotherapy techniques; accelerating the evaluation of novel agent drug and radiotherapy combinations; and more efficient translational research opportunities, leading to cost savings and research efficiency to improve patient outcomes.<\/jats:p>\n               <jats:p>Master protocols offer an innovative platform under which multiple clinical questions can be addressed within a single trial. Due to the complexity of radiotherapy trial setup, cost and research efficiency savings may be more apparent than in systemic treatment trials. Use of this research approach may be the change needed to push forward oncological innovation within radiation oncology.<\/jats:p>","DOI":"10.1093\/jnci\/djae084","type":"journal-article","created":{"date-parts":[[2024,5,9]],"date-time":"2024-05-09T06:30:20Z","timestamp":1715236220000},"page":"1220-1229","source":"Crossref","is-referenced-by-count":10,"title":["The use of master protocols for efficient trial design to evaluate radiotherapy interventions: a systematic review"],"prefix":"10.1093","volume":"116","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9142-1227","authenticated-orcid":false,"given":"Alexandra","family":"Gilbert","sequence":"first","affiliation":[{"name":"Leeds Institute for Medical Research, University of Leeds, St James\u2019s University Hospital , Leeds, UK"},{"name":"Leeds Cancer Research UK Clinical Trials Unit, Leeds Institute of Clinical Trials Research, University of Leeds , Leeds, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Samuel","sequence":"additional","affiliation":[{"name":"Leeds Institute for Medical Research, University of Leeds, St James\u2019s University Hospital , Leeds, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Cagney","sequence":"additional","affiliation":[{"name":"Radiation Oncology, Mater Private Hospital , Dublin, Ireland"},{"name":"Royal College of Surgeons in Ireland, University of Medicine and Health Sciences , Dublin, Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Sebag-Montefiore","sequence":"additional","affiliation":[{"name":"Leeds Institute for Medical Research, University of Leeds, St James\u2019s University Hospital , Leeds, UK"},{"name":"Leeds Cancer Research UK Clinical Trials Unit, Leeds Institute of Clinical Trials Research, University of Leeds , Leeds, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Brown","sequence":"additional","affiliation":[{"name":"Leeds Cancer Research UK Clinical Trials Unit, Leeds Institute of Clinical Trials Research, University of Leeds , Leeds, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah R","family":"Brown","sequence":"additional","affiliation":[{"name":"Leeds Cancer Research UK Clinical Trials Unit, Leeds Institute of Clinical Trials Research, University of Leeds , Leeds, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,4,27]]},"reference":[{"issue":"9","key":"2024080815312677000_djae084-B1","doi-asserted-by":"crossref","first-page":"1293","DOI":"10.7326\/M21-1269","article-title":"Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): designing master protocols for evaluation of candidate COVID-19 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