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FDA-ASCO Public Workshop: 2019 Clinical Outcome Assessments in Cancer Clinical Trials
July 12 @ 8:15 am - 4:30 pm EDT
The one-day workshop 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.