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Advancing the Science of Study Endpoints
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
- Senior Vice President
- Critical Path Institute, United States
Endpoint Selection and Positioning
Lisa Kammerman, PhD, MS
- Regulatory Statistics and PRO Consultant
- Kammerman Consulting, LLC, United States

Time to Deterioration Endpoints in Oncology Clinical Trials
Bellinda King-Kallimanis, PhD
- Senior Staff Fellow, CDER, OHOP
- FDA, 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