On June 22, ASCO and the Food and Drug Administration (FDA) will co-host an event, the Core Outcome Assessments in Cancer Clinical Trials workshop. The full-day workshop, which will take place at the FDA White Oak Campus in Silver Spring, Md., aims to bring together international regulators, payers, members of industry and academia, and patients to advance the science of clinical outcome assessments, which is measuring how patients feel and function. This year’s event will focus on patient-related outcomes (PROs) as they relate to clinical trials, and the FDA Oncology Center of Excellence will use the venue to clarify its position on measuring PROs.
This annual event examines topics beyond the standard assessment endpoints of survival and tumor measurements, including improving methods to quantify how patients experience symptoms and the impact on physical functional outcomes and health-related quality of life.
Featured speakers at this year’s event will include Paul G. Kluetz, MD, acting associate director of patient outcomes, Oncology Center of Excellence, FDA, and Heidi Klepin, MD, chair-elect of ASCO’s Cancer Research Committee. There will be four sessions comprising presentations and panel discussions on the topics of:
- Proposed Framework for PRO Assessment in Cancer Trials
- Case-Based Examples of PRO Strategies
- International Collaboration to Standardize PRO Analysis – SISAQOL
- Using PRO data in regulatory review: Current FDA approaches to Acute/Subacute Descriptive Patient Experience Data.
Register to attend the workshop.
For news and updates about this event, as well as discussion surrounding it, follow the event hashtag on Twitter: #OCEOutcomes.