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Publication: General review OPTIMISE-ROR

Publication: General review OPTIMISE-ROR

International Consensus-Driven Recommendations for Patient-Reported Outcome Research Objectives in Early Phase Dose-Finding Oncology Trials: OPTIMISE-ROR

There is growing scientific interest in incorporating patient-reported outcomes (PROs) in early phase dose-finding oncology trials (DFOTs) to assess tolerability, inform dose selection, and guide later stage trial design. However, research indicates that PRO objectives in DFOTs are often unclear. The Incorporating Patient-Reported Outcomes in Dose-Finding Trials-Research Objectives Recommendations (OPTIMISE-ROR) project was established to support trialists to effectively incorporate PROs into DFOTs.

Alger E, Aiyegbusi OL, Dueck AC, Minchom A, Pe M, Peipert JD, Snyder C, Symeonides SN, Wilson R, Basch E, Qiao Y, Bates SE, Bulbeck H, Dean L, Di Maio M, Hansen AR, Kholmanskikh O, Kobayashi K, Landers D, Le Tourneau C, Lee JJ, Ma BBY, Marshall LV, Patel S, Petrie J, Pond GR, Prior K, Rantell KR, Reeve JF, Solovyeva O, Wages NA, Weber HA, Calvert MJ, Yap C. International Consensus-Driven Recommendations for Patient-Reported Outcome Research Objectives in Early Phase Dose-Finding Oncology Trials: OPTIMISE-ROR (ONLINE). Journal of Clinical Oncology 2026.