A practical toolkit with recommendations for analysing and visualising patient-reported outcomes in early phase dose-finding oncology trials (OPTIMISE-AR) - PubMed
4 hours ago
- #Patient-reported outcomes
- #Oncology trials
- #Data visualization
- OPTIMISE-AR provides a toolkit for analyzing and visualizing patient-reported outcomes (PROs) in early phase dose-finding oncology trials (DFOTs).
- The toolkit addresses unclear and inconsistent PRO data analysis and reporting in DFOTs.
- International, multidisciplinary working groups identified analytical and visualization approaches for PRO data.
- The toolkit includes case studies and recommendations for binary, ordinal, and continuous PRO data analysis.
- Four methodological domains guide the toolkit: PRO endpoints across timepoints, between timepoints, time-to-event PRO endpoints, and PRO endpoints for dose-decision making.
- The toolkit aims to support robust, patient-centered tolerability conclusions and effective treatment development.
- The Policy Review promotes the use of PRO data in tolerability assessment and dose-finding designs.