Patient-reported outcomes (PROs) are increasingly recognised for their role in assessing tolerability in dose-finding oncology trials (DFOTs). However, analysis and reporting of PRO data within DFOTs are often unclear and inconsistent.
OPTIMISE-AR (Incorporating Patient-Reported Outcomes in Dose-Finding Trials–Analysis Recommendations) establishes a practical toolkit supporting the statistical analysis, visualisation, and reporting of PRO data within DFOT publications. International, multidisciplinary, cross-sector statistical analysis and data visualisation working groups identified analytical and visualisation approaches for PROs data, addressing key DFOT PRO research objectives.
The Lancet Oncology published a clinical update in Oncology on 17 Mar 2026.
The item focuses on A practical toolkit with recommendations for analysing and visualising patient-reported outcomes in early phase dose-finding oncology trials (OPTIMISE-AR).
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