Patient-Reported Outcomes in Clinical Trials: From an Endpoint to an Intervention in Cancer Care

Abstract

Underreporting of patient symptoms by clinicians is a common and well-documented phenomenon that has led to integrating patient-reported outcomes (PROs) as endpoints into clinical trials. While PROs are often used to measure disease symptoms, cancer therapy toxicities, and quality of life, they can also assess patients’ general experiences and preferences. With the increasing use of electronic medical records and the digital health revolution in oncology, conversion from paper to electronic PROs (ePROs) has also facilitated the integration of PROs into routine care. Evidence from clinical trials is rapidly emerging to support ePROs as a care delivery innovation, given the potential for ePROs to improve patient outcomes through timely evaluation and response to patient needs. Meanwhile, work is ongoing to understand and address ePRO use and challenges to equitable integration, including technical and language barriers for patients, clinicians, and health systems. Nonetheless, the health system and regulatory bodies continue to develop stipulations to promote the use of ePROs. Herein, we review the evolution of PROs from an endpoint to an intervention in prospective clinical trials in oncology.