The agenda has been set for the June 22 ASCO/Food and Drug Administration (FDA) “Core Outcome Assessments in Cancer Clinical Trials” workshop.
The full-day event will open with remarks by the chair-elect of ASCO’s Cancer Research Committee, Heidi Klepin, MD, and Paul Kluetz, MD, acting associate director of patient outcomes at the FDA’s Oncology Center of Excellence.
Following this introduction will be four 90-minute panels, each one comprised of presentations, a panel discussion, and a question-and-answer session:
- Session 1: WHAT to measure: PRO Core Concepts in Cancer Trials
- Session 2: HOW to measure: Case Based Examples of PRO Strategies
- Session 3: Efforts to Standardize PRO Analysis Methods
- Session 4: Using PRO data in regulatory review: Current FDA approaches to Acute/SubAcute Descriptive Patient Experience Data.
The workshop, which will take place at the FDA White Oak Campus in Silver Spring, Md., brings together international regulators, payers, members of industry and academia, and patients to advance the science of clinical outcome assessments and to examine topics beyond the standard assessment endpoints of survival and tumor measurements.
Register to attend the workshop in person or by teleconference.
View the full agenda.
For news and updates about this event, as well as discussion surrounding it, follow the event hashtag on Twitter: #OCEOutcomes.