PCN315 TIME-BASED VS CYCLE-BASED APPROACHES TO ACCOUNT FOR PATIENT-REPORTED OUTCOME (PRO) ASSESSMENTS IN ONCOLOGY TRIALS

Abstract

In oncology trials, dose delays can uncouple dosing from nominal visits, which may impact longitudinal analyses of PRO data. This study evaluated two approaches to account for the timing of PRO assessments relative to dosing when performing analyses of oncology trial data.