Registration is now open for the 4th Annual U.S. Food and Drug Administration (FDA) Clinical Outcome Assessments in Cancer Clinical Trials Workshop, which will take place on July 12 at the FDA White Oak Campus in Silver Spring, Maryland. The 1-day workshop, which will be co-hosted by ASCO and the 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 the quantification of how patients experience symptoms and their impact on important functional outcomes is a critical addition to the 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 patient-reported outcomes assessment to facilitate learning health-care systems
- Systematically defining research objectives and framing questions using the estimand framework
- Standardizing 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 at the FDA’s Oncology Center of Excellence, and Heidi Klepin, MD, Chair of ASCO’s Cancer Research Committee, are co-chairing the event.
The FDA will provide a live and free 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.
Register to attend the workshop at https://www.surveymonkey.com/r/2019COA-CCT.
For news and updates about this event, as well as discussion surrounding it, follow the event on Twitter using the hashtag #OCEOutcomes. ■
© 2019. American Society of Clinical Oncology. All rights reserved.
