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There is an urgent need for more patient-centric approaches, with meaningful patient input from trial design through to health technology assessment (HTA) consultation. Multi-stakeholder consensus calls for better representation of the diversity of the target population and integration of patients\u2019 preferences in clinical cancer research by systematically collecting patient-reported outcomes using standardized methods, and acknowledging trade-offs between survival and long-term wellbeing. Furthermore, the generation of insufficiently robust data for regulatory and HTA decision-making continue to delay patient access to innovation. This could be mitigated through smarter study designs, including smaller, fit-for-purpose randomized studies and prospectively designed trials. 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J Natl Cancer Inst. 2003;95(20):1545\u20138.","journal-title":"J Natl Cancer Inst"}],"container-title":["Therapeutic Innovation &amp; Regulatory Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-026-00936-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s43441-026-00936-w","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-026-00936-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T15:02:57Z","timestamp":1780066977000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s43441-026-00936-w"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,7]]},"references-count":59,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,5]]}},"alternative-id":["936"],"URL":"https:\/\/doi.org\/10.1007\/s43441-026-00936-w","relation":{},"ISSN":["2168-4790","2168-4804"],"issn-type":[{"value":"2168-4790","type":"print"},{"value":"2168-4804","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,7]]},"assertion":[{"value":"14 October 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 February 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 March 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"AG\n                      is a member of the CDDF board of directors and of the supervisory boards of Ryvu Therapeutics SA and Active Biotech AB; he has received consultancy fees from Active Biotech AB and Oncopeptides AB.\n                      BW\n                      is an employee of Bayer AG, Berlin Germany.\n                      PZ\n                      is an employee of Debiopharm International S.A., Lausanne, Switzerland.\n                      EC\n                      is an employee of Roche Products Limited, UK.\n                      BP\n                      reports consultancy fees from BMS-Celgene, GSK, Janssen, Roche, Sanofi, and Takeda; research funding from AstraZeneca, Beigene, BMS, GSK, Roche, and Sanofi; honoraria from Adaptive, Amgen, Becton\/Dickinson Biosciences, BMS-Celgene, GSK, Janssen, Roche, and Sanofi.\n                      CUG\n                      reports funding from Astellas, Sanofi, Jansen-Cilag Bayer, Amgen, Merck, Gilead, Novartis, AstraZeneca, Roche, National Institute of Health (NIH), Dutch Health Care Institute (ZIN), Horizon Europe projects ASCERTAIN and DEFINITIVE. All payments to Erasmus University Rotterdam.\n                      JV\n                      is a consultant to Boehringer Ingelheim, IDRX, and DeuterOncology.\n                      KL\n                      ,\n                      LZ\n                      ,\n                      PZ\n                      ,\n                      MM\n                      ,\n                      AS\n                      ,\n                      FS\n                      and\n                      MLT\n                      have nothing to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}