Playing Catch-Up: FDA Wants 'Patient's Voice' ePRO In Your Oncology Trial

Patient-centricity is no longer optional in oncology trials—it’s a regulatory expectation. The FDA is signaling a clear shift toward integrating patient-reported outcomes (PROs) and electronic PROs (ePROs) to capture real-world experiences that traditional endpoints often miss. This evolution reflects a growing recognition that patient voices provide critical insights into treatment tolerability, quality of life, and long-term outcomes.

Sponsors who fail to incorporate these measures risk not only regulatory delays but also diminished trial relevance in an increasingly competitive landscape. Implementing ePRO solutions early can streamline data collection, improve compliance, and enhance the overall trial experience for participants. Beyond meeting FDA guidance, these tools offer a strategic advantage: richer datasets that inform both clinical and commercial decisions.

Explore why prioritizing patient input is essential for future-ready oncology trials and how proactive adoption can position your organization ahead of regulatory and market expectations. Access the full resource to learn actionable strategies for integrating ePRO into your next study.