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Bethesda North Marriott Hotel and Conference Center

Sep 20, 2018 7:00 AM - Sep 21, 2018 12:45 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Advancing the Science of Study Endpoints

Session 6: Endpoint Evolution During Drug Development – Time to Deterioration Endpoint Case Study

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

Stephen Joel Coons, PHD

Senior Advisor, Critical Path Institute, United States

From Outcomes to Endpoints

Lisa A Kammerman, PHD, MS

Lisa A Kammerman, PHD, MS

Regulatory Statistics and PRO Consultant, Kammerman Consulting, LLC, United States

Endpoint Selection and Positioning

Bellinda  King-Kallimanis, PHD, MSC

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

Paul Kluetz, MD

Deputy Director, Oncology Center of Excellence, OC, FDA, United States

Time to Deterioration Endpoints in Oncology Clinical Trials

Jessica  Roydhouse, PHD

Jessica Roydhouse, PHD

ORISE Fellow, FDA, United States

Time to Deterioration Endpoints in Oncology Clinical Trials

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