Patient-Reported Outcome In Oncology Clinical Trials

As cancer therapies grow more complex and personalized, patient-reported outcomes (PROs) have emerged as a vital component of oncology research and care. Traditionally overlooked in favor of treatment efficacy, the patient’s perspective—particularly regarding symptoms, treatment impact, and quality of life—is now recognized as essential. Advances in digital tools and data accessibility have made PROs more feasible and meaningful, shifting the focus from passive data collection to active patient engagement. Regulatory bodies like the EMA and FDA have issued specific guidelines for incorporating PRO measures in clinical trials, and oncology societies such as ESMO have endorsed their integration from diagnosis through end-of-life care.

Beyond quality of life, PROs now encompass treatment adherence, care satisfaction, and symptom burden, with particular value in immunotherapy where novel toxicities demand real-time insight. With over a thousand oncology trials including PRO endpoints, the approach is becoming standard practice. By empowering patients and refining clinical insight, PROs are transforming cancer care—enabling data-driven personalization and supporting the shift toward value-based healthcare. As a result, PROs are not just supplementary data points, but a foundation for future therapeutic evaluation and delivery.