FDA lays out cancer PRO strategy

FDA staff set out the agency’s thinking and progress in developing a standard approach to assessing patient reported outcomes (PROs) at a workshop Friday to discuss clinical outcome assessments in cancer trials. The joint FDA-American Society of Clinical Oncology (ASCO) meeting included participants from European and North American regulatory bodies, industry, academia and patient advocates.

Oncology Center of Excellence (OCE) Associate Director of Patient Outcomes Paul Kluetz said FDA plans to first choose a core set of PRO domains to study in trials, then consider how to incorporate them in trials to meet different trial objectives, and lastly to standardize the analytical methods used to evaluate them...