When patient advocates take the stage: Insights from the FDA’s 11th Annual Oncology COA Workshop

If there was one theme that resonated throughout the FDA’s 11th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop (held on October 15, 2026), it was this: the patient voice is becoming one of the most influential forces shaping the future of oncology research. While patient advocates have always been represented in prior workshops, this workshop featured an agenda completely dominated by patient advocates, every panelist was an advocate, reinforcing the FDA’s continued emphasis on ensuring that patient voices shape both clinical development strategies and regulatory decision-making. 

PRO strategies must evolve with oncology treatments

One of the clearest indicators of progress is the growing presence of patient-reported outcome (PRO) data in oncology product labeling. The workshop highlighted that FDA oncology labels increasingly include patient experience data, reflecting years of investment by regulators, sponsors, and researchers in demonstrating the value of PRO evidence. At the same time, FDA speakers acknowledged that traditional PRO approaches may no longer be sufficient for modern oncology therapies, particularly as novel treatments such as CAR-T therapies and antibody-drug conjugates create new and long-term symptom profiles. PRO assessment schedules can no longer be “one size fits all”; they must be tailored to the mechanism of action, toxicity profile, and expected patient experience.

Long-term patient experience requires long-term measurement

Perhaps the most important theme of the day was the growing recognition that oncology trials have historically focused on acute treatment periods while under-measuring long-term patient experiences. Multiple patient advocates emphasized that many toxicities persist for months or years, fundamentally reshaping daily life long after treatment begins. Discussions repeatedly returned to the need for longitudinal assessment strategies that capture not only symptom severity, but also how those symptoms affect independence, work, social functioning, and quality of life over time and throughout survivorship.

Real-time monitoring could reshape oncology trials

The workshop’s most forward-looking discussion, which arguably had the most audience engagement, centered on real-time PRO monitoring, a topic that feels increasingly likely to shape the next generation of oncology trials. Panelists broadly agreed that real-time symptom monitoring (versus only using PROs for results analysis) could help improve symptom management, potentially prevent hospitalizations, and could help to reinforce patient engagement with PRO completion during the trial. The FDA moderator noted that while real-time PRO monitoring is not currently a regulatory expectation, it is already becoming common in clinical practice and may eventually become a natural extension of oncology clinical trials. The key questions are no longer whether it is valuable, but rather how to implement it responsibly, who owns the alerts, what thresholds should trigger action, and how to preserve scientific rigor while prioritizing patient safety.

Technology must support meaningful patient partnership

Technology will be a critical enabler of this future. Discussions highlighted how electronic PRO (ePRO) platforms and wearable technologies may allow more frequent, home-based assessments that better reflect patients’ real-world experiences, and could more easily support symptom monitoring. The FDA moderator even noted that, generally speaking, compliance rates are often higher with ePRO than with paper-based data collection, highlighting one of the many reasons for the industry’s continued shift toward digital approaches. AI also emerged as a promising tool for identifying symptom patterns, detecting changes that may warrant attention, and helping clinical teams manage the growing volume of patient-generated data. Importantly, speakers stressed that patients should be involved in determining how these tools are designed, deployed, and interpreted. 

Another recurring theme was patient partnership. Across nearly every discussion, advocates challenged industry to move beyond consultation and toward true co-design. Patients were described as collaborators who should influence protocol development, outcome selection, assessment schedules, and communication strategies from the earliest stages of trial planning. Equally important was the need to clearly communicate why PROs are being collected, how the data will be used, and the impact it can have on research and care. Panelists emphasized that helping patients understand the value of their contributions is critical to driving engagement, sustained participation, and PRO completion throughout a study.