{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T17:09:12Z","timestamp":1784912952072,"version":"3.55.0"},"reference-count":35,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T00:00:00Z","timestamp":1778112000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T00:00:00Z","timestamp":1778112000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Asia-Pac J Clncl Oncology"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Randomized controlled trials (RCTs) have historically been considered the \u2018gold standard\u2019 for generating evidence about emerging cancer therapies. However, conducting conventional RCTs has become increasingly challenging due to the increasing subdivision of cancer into smaller subtypes, the cost of conducting large\u2010scale trials, and various ethical concerns. The use of \u2018external controls\u2019 has received increased attention of late as a potential mechanism for generating evidence in circumstances when obtaining RCT\u2010level evidence is deemed infeasible (or otherwise challenging). External controls encompass a variety of statistical techniques whereby data are sourced from \u2018real world\u2019 or other settings and form the basis of comparative analyses. However, there are concerns about the potential for bias and other challenges to the veracity of non\u2010randomized data. Official guidance regarding the appropriate use of external controls also varies widely across jurisdictions and agencies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this qualitative study, 52 semi\u2010structured interviews were conducted with key stakeholders across the cancer clinical trials landscape to explore perspectives regarding external controls in oncology. This included various types of \u2018trial experts\u2019 (trialists, statisticians, ethicists, ethics review board members, industry, regulatory, and reimbursement body representatives).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Data arising from interviews converged on three main themes: (a) support for randomization and the methodological limitations of non\u2010randomized controls, (b) consideration as to possible utility of external controls, and (c) the relationship of external controls to public decision\u2010making.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Findings of this study highlight the \u2018value laden\u2019 nature of apparently technical questions about evidence generation and the need for further studies to systematically recognize, articulate and balance values of trustworthiness, efficiency, and fairness.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/ajco.70120","type":"journal-article","created":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T09:53:31Z","timestamp":1778147611000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Navigating Evidence Standards: Stakeholder Perspectives on External Controls and Randomization in Cancer Trials"],"prefix":"10.1111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2205-5320","authenticated-orcid":false,"given":"Sarah E.","family":"Heynemann","sequence":"first","affiliation":[{"name":"Sydney Health Ethics Faculty of Medicine and Health The University of Sydney  Sydney Australia"},{"name":"Department of Oncology Northern Health  Melbourne Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wendy L.","family":"Lipworth","sequence":"additional","affiliation":[{"name":"Discipline of Philosophy School of Humanities Macquarie University  Sydney Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sue\u2010Anne","family":"McLachlan","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology St Vincent's Hospital  Melbourne Australia"},{"name":"Department of Medicine Faculty of Medicine Dentistry and Health Sciences The University of Melbourne  Melbourne Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Philip","sequence":"additional","affiliation":[{"name":"Department of Medicine Faculty of Medicine Dentistry and Health Sciences The University of Melbourne  Melbourne Australia"},{"name":"Department of Palliative Care St Vincent's Hospital  Melbourne Australia"},{"name":"Department of Palliative Care Peter MacCallum Cancer Centre  Melbourne Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"John","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Peter MacCallum Cancer Centre  Melbourne Australia"},{"name":"Sir Peter MacCallum Department of Medical Oncology The University of Melbourne  Melbourne Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian H.","family":"Kerridge","sequence":"additional","affiliation":[{"name":"Sydney Health Ethics Faculty of Medicine and Health The University of Sydney  Sydney Australia"},{"name":"Discipline of Philosophy School of Humanities Macquarie University  Sydney Australia"},{"name":"Department of Haematology Royal North Shore Hospital Sydney Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,5,7]]},"reference":[{"key":"e_1_2_10_2_1","volume-title":"Oxford Centre for Evidence\u2010Based Medicine: Levels of Evidence (March 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