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Session 6: Endpoint Evolution During Drug Development – Time to Deterioration Endpoint Case Study
Session Chair(s)
J. Jason Lundy, PHD
Principal , Outcometrix, United States
Learning Objective : Upon completion of this session, participants should be able to:- Describe the difference between outcome measures and endpoints
- Formulate appropriate strategies to collect and analyze COA endpoint data
- Apply the concept of symptom deterioration to the selection and positioning of clinical trial endpoints in chronic diseases (e.g., oncology)
Speaker(s)
Stephen Joel Coons, PHD
Senior Advisor, Critical Path Institute, United States
From Outcomes to Endpoints
Lisa A Kammerman, PHD, MS
Regulatory Statistics and PRO Consultant, Kammerman Consulting, LLC, United States
Endpoint Selection and Positioning
Bellinda King-Kallimanis, PHD, MSC
Senior Director of Patient-Focused Research , Lungevity Foundation, United States
Time to Deterioration Endpoints in Oncology Clinical Trials
Paul Kluetz, MD
Deputy Director, Oncology Center of Excellence, OC, FDA, United States
Time to Deterioration Endpoints in Oncology Clinical Trials
Jessica Roydhouse, PHD
ORISE Fellow, FDA, United States
Time to Deterioration Endpoints in Oncology Clinical Trials