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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)
From Outcomes to Endpoints
Stephen Joel Coons, PhD
Critical Path Institute, United States
Senior Advisor
Endpoint Selection and Positioning
Lisa Kammerman, PhD, MS
Kammerman Consulting, LLC, United States
Regulatory Statistics and PRO Consultant
Time to Deterioration Endpoints in Oncology Clinical Trials
Bellinda King-Kallimanis, PhD, MSc
Lungevity Foundation, United States
Senior Director of Patient-Focused Research
Time to Deterioration Endpoints in Oncology Clinical Trials
Paul Kluetz, MD
FDA, United States
Deputy Director, Oncology Center of Excellence, OC
Time to Deterioration Endpoints in Oncology Clinical Trials
Jessica Roydhouse, PhD
FDA, United States
ORISE Fellow