Patient Reported Outcomes (PROs) are particularly relevant in therapeutic areas where clinical diagnosis and management is based primarily on how the patient responds to healthcare provider questions. In those therapeutic areas, PROs are generally included in randomized clinical trials as the primary endpoint; however, for almost all other therapeutic areas, PROs are included only as secondary or exploratory objectives. Current PRO guidance does not address scientific limitations resulting from the lack of a comparator in single arm (SA) registrational clinical trials. This review focuses on the utilization of PROs in oncology SA registrational trials incorporating an ECA to better understand the scope of the problem.
