A New Scoring Method for Ordering Components within the Composite Endpoint in Oncology Trials

Oregon Convention Center 

In clinical trials, patient-reported outcomes (PRO), encompassing multiple scales, have been widely used in measuring patients' quality of life, especially in oncology trials. The generalized pairwise comparison (GPC) combines the primary endpoint (e.g., overall survival) and PRO as the composite endpoint to assess the treatment effect. The prioritized GPC method requires a well-defined hierarchical order for each component within the composite endpoint. However, establishing a clear ranking order for each PRO scale is challenging. Non-prioritized GPC methods treat all components equally, thereby diminishing the importance of the primary endpoint. In response, we propose a semi-prioritized method that avoids the need for a strict order of PRO scales while simultaneously preserving the importance of the primary endpoint. We redefined the scoring algorithm, utilizing all endpoints observed in a trial to estimate the composite treatment effect, with particular emphasis on the primary endpoint. We conducted comprehensive simulation studies to assess the limitations of existing methods and applied all tests to data from an oncology trial.

Generalized Pairwise Comparison

Composite Endpoint

Patient-Reported Outcomes

Oncology Trials 

Biopharmaceutical Section