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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

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

Session Chair(s)

J. Jason Lundy, PhD

J. Jason Lundy, PhD

Principal

Outcometrix, United States

To sufficiently define a clinical trial endpoint, both a relevant clinical outcome and an appropriate statistical test are needed. In addition, the interpretation (or clinical meaningfulness) of that data also should be specified. This session will describe the distinction between outcomes and endpoints, and discuss the evolution of endpoints throughout the drug development lifecycle. Time to deterioration endpoints in oncology clinical trials will be used as a case-study to illustrate endpoint positioning and interpretation.

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

Time to Deterioration Endpoints in Oncology Clinical Trials

Bellinda King-Kallimanis, PhD

LUNGevity, 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

Time to Deterioration Endpoints in Oncology Clinical Trials

Jessica Roydhouse, PhD

FDA, United States

ORISE Fellow