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Boston Convention and Exhibition Center

Jun 23, 2013 8:30 AM - Jun 27, 2013 12:45 PM

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Evaluation and Selection of the Optimal Endpoints for Clinical Studies

Session Chair(s)

Freda  Cooner, PhD

Freda Cooner, PhD

Senior Director - Statistics

Eli Lilly and Company, United States

An endpoint for measuring the disease severity and treatment comparison is not always readily definable. We will discuss why it is important to select true patients and properly quantify treatment effects in considering endpoints.

Learning Objective : Identify the difficulty of characterization of certain diseases, measurement of disease severities, and quantification of treatment effect; Discuss the evolution of endpoints development.

Speaker(s)

Debra G. Silberg, MD, PhD

Patient Reported Outcomes as Endpoints for Clinical Studies

Debra G. Silberg, MD, PhD

Shire Specialty Pharmaceuticals, United States

Senior Director, Clinical Development

Anil  Rajpal, MD, MPH

Evaluation and Selection of Endpoints for Ulcerative Colitis

Anil Rajpal, MD, MPH

FDA, United States

Medical Team Leader, Div. Gastroenterology and Inborn Errors Products, OND, CDER

Nandini  Raghavan, PhD, MSc

Outcome Measures for Clinical Trials in the Early Stages of Alzheimer’s Disease

Nandini Raghavan, PhD, MSc

Janssen Research & Development, LLC, United States

Associate Director, Biometrics

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