PRO-ADD: Patient-empowered dose-finding trials integrating safety, preliminary efficacy and patient-reported outcomes for optimal dose selection.

esign), a modular trial design framework for dose-optimisation. We leverage this framework to optimise dosage with respect to three key outcomes - clinician-assessed DLTs, PROs and preliminary efficacy. PRO-ADD performs well at identifying the optimal dose (both efficacious and tolerable) - successfully identifying the most tolerable effective dose and avoiding escalation to larger, safe doses offering no additional efficacy benefit. As the field evolves, patient-centric dose-finding approaches incorporating PROs are crucial in advancing our understanding of treatment tolerability, and in turn, shaping the future landscape of dose-finding oncology trials.