American Statistical Association
New York City
Metropolitan Area Chapter

Mailman School of Public Health
Columbia University
Department of Biostatistics Colloquium



CONFIRM AND EXPLORE:
A STEPWISE APPROACH TO CLINICAL STUDY DESIGNS

by

Dr. Naitee Ting
Director, Biostatistics
Pfizer Inc., Global Research & Development


Abstract

The scientific research and development process usually starts with an idea. Scientists then conduct experiments to explore and learn about this idea using data collected from this experiment. Some experiments are refined and repeated until a conclusion can be formulated, hence confirm or reject this idea. This follows an explore, then confirm thinking process.

On the other hand, most of the Phase II or III clinical trials are designed with a confirmatory objective. After this objective is reached, then clinical scientists will learn from clinical data collected in this study. Hence, the study design should start with a confirmatory step to determine if the primary objective is achieved and then followed by an exploratory step to learn from the study. This article discusses the stepwise process of study design, and provides examples of how this thinking process is applied in actual situations.


Date: Thursday, February 7, 2008
Time: 4:00 - 5:00 P.M.
Location: Mailman School of Public Health
Department of Biostatistics
722 West 168th Street
Judith Jansen Conference Room
4th Floor - Room 425
New York, New York

RESERVATIONS ARE NOT REQUIRED

Refreshments will be served at 3:30 P.M. in the
Biostatistics Conference Room (R627).


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