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Bethesda North Marriott Hotel and Conference Center

2018 年 09 月 20 日 7:00 上午 - 2018 年 09 月 21 日 12:45 下午

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

From Outcomes to Endpoints

Stephen Joel Coons, PhD

Critical Path Institute, United States

Senior Advisor

Lisa  Kammerman, PhD, MS

Endpoint Selection and Positioning

Lisa Kammerman, PhD, MS

Kammerman Consulting, LLC, United States

Regulatory Statistics and PRO Consultant

Bellinda  King-Kallimanis, PhD, MSc

Time to Deterioration Endpoints in Oncology Clinical Trials

Bellinda King-Kallimanis, PhD, MSc

Lungevity Foundation, United States

Senior Director of Patient-Focused Research

Paul  Kluetz, MD

Time to Deterioration Endpoints in Oncology Clinical Trials

Paul Kluetz, MD

FDA, United States

Deputy Director, Oncology Center of Excellence, OC

Jessica  Roydhouse, PhD

Time to Deterioration Endpoints in Oncology Clinical Trials

Jessica Roydhouse, PhD

FDA, United States

ORISE Fellow

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