Registration is now open for the 4th Annual FDA Clinical Outcome Assessments in Cancer Clinical Trials (COA-CCT) Workshop, which will take place on July 12 at the FDA White Oak Campus in Silver Spring, Maryland. The one-day workshop, which will be co-hosted by ASCO and the Food and Drug Administration (FDA), will bring together international regulators, payers, industry, academia, and patients to advance the science of clinical outcome assessments – measuring how patients feel and function.
Improving how we quantify how patients experience symptoms and their impact on important functional outcomes is a critical addition to standard endpoints of survival and tumor measures. This year’s workshop will explore how physical function assessment can be incorporated into oncology trials and analyzed for regulatory decision making, with the goal of generalizing what can be learned to other forms of clinical assessments. There will be sessions on:
- Exploring the value of electronic PRO assessment to facilitate learning healthcare systems
- Systematically defining research objectives and framing questions using the estimand framework
- Efforts to standardize an analysis framework for physical function in medical product review and labeling
- Generalizing physical function learnings.
Paul G. Kluetz, MD, acting associate director of patient outcomes, Oncology Center of Excellence, FDA, and Heidi Klepin, MD, chair of ASCO’s Cancer Research Committee, are co-chairing the event.
Register to attend the workshop.
FDA will provide a free, live webcast of this workshop. Further information regarding the webcast, including the web link for the webcast, will be made available closer to the workshop date. The webcast will be archived and posted following the meeting.
For news and updates about this event, as well as discussion surrounding it, follow the event hashtag on Twitter: #OCEOutcomes.