1. Home
  2. News & Events
  3. FDA Meetings, Conferences and Workshops
  4. FDA WORKSHOP: 11th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop - 10/15/2026
  1. FDA Meetings, Conferences and Workshops

Virtual | Virtual

Event Title
FDA WORKSHOP: 11th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop
October 15, 2026

Measuring What Matters: The Patient Voice in Cancer Clinical Trials

Date:
October 15, 2026
Time:
1:00 p.m. - 4:00 p.m. ET
Organized By:
Organizer

Presented by the Oncology Center of Excellence

 

Background

The FDA Oncology Center of Excellence will host the 11th Annual COA-CCT Workshop on October 15, 2026. This year's workshop asks a defining question: after more than a decade of progress in patient-reported outcome science, are we truly measuring what matters most to patients? The workshop features two panel sessions, with the majority of panelists being patient advocates with personal cancer experience. Session 1 examines critical gaps in current outcome frameworks driven by novel therapies, longer survivorship, and the need for more frequent and real-time data collection. Session 2 takes a forward-looking view, exploring patient co-design, emerging technologies, and actionable milestones for sponsors and the research community. Together, the sessions advance FDA OCE's patient-focused drug development mission.

Meeting Goals

  1. Examine how novel cancer therapies – including CAR-T, bispecific antibodies, and ADCs – have created gaps in existing PRO frameworks that patients experience but current measures may not capture
  2. Explore what patients living with cancer as a chronic condition need measured beyond the acute treatment window, and how survivorship outcomes can be better integrated into trial design
  3. Discuss the gap between PRO data collection and real-time clinical utility, and what closing that loop would mean for patients in trials
  4. Consider the evidence and feasibility for high frequency PRO assessment during the first treatment cycle as a meaningful extension of current FDA guidance recommendations
  5. Envision what genuine patient co-design of cancer clinical trials looks like in practice and identify concrete steps sponsors can take to move from consultation to true partnership
  6. Explore how emerging technologies – ePRO platforms, wearables, AI-assisted monitoring – can be designed and deployed in ways that serve patients first, including through more frequent and meaningful data collection 
  7. Articulate a patient-centered vision for what the next decade of PRO science should achieve, with specific, actionable milestones that sponsors, regulators, and the research community can work toward together 

Workshop Materials

  • Agenda (forthcoming)
  • Biographies (forthcoming)

For past COA-CCT workshops, go to the events section of the FDA OCE Patient-Focused Drug Development Program webpage. 

Contacts

Caitlin Drew, MSN, RN
Senior Health Scientist 
Oncology Center of Excellence, (OCE)
Office of the Commissioner (OC)
U.S. Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993
Tel: 301.318.8609
Caitlin.Drew@fda.hhs.gov

Back to Top