戻る Agenda
Evaluation and Selection of the Optimal Endpoints for Clinical Studies
Session Chair(s)
Freda Cooner, PHD
Statistician
FDA, 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)
Patient Reported Outcomes as Endpoints for Clinical Studies
Debra G. Silberg, MD, PHD
Shire Specialty Pharmaceuticals, United States
Senior Director, Clinical Development
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
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