Department of Statistics Seminar
North Carolina State University

presents

Peter Mesenbrink

Novartis Pharmaceuticals

"Practical Aspects of Adaptive Designs in Clinical Trials"

ABSTRACT

Practical Aspects of Adaptive Designs in Clinical Trials Abstract: Throughout the pharmaceutical industry over the past few years, there has been increased emphasis on the efficiency by which clinical trials/programs are designed and analyzed. Many times, the amount of historical information available prior to starting one or more clinical trials is not at the highest level of precision. Thus, once information is available some of the decisions that were made during the trial design process could need to be modified in order to conform with a more realistic scenario. These situations have led to the evolution of adaptive design methodology as an extension to the group sequential design methodology. After discussing some of the history behind the evolution of the adaptive design methodology, I will discuss strategies for adapting sample sizes during clinical trials which will lead into a discussion the strategy for creating an adaptive design for a clinical trial and the differences that exist with this strategy relative to a group sequential designs. Once the trial is designed, the proper execution of an adaptive design is also essential and recommendations of these techniques will be discussed followed by examples of how to use adaptive design methodology to design a combination Phase II/III clinical development program and how to use adaptive design methodology to switch hypotheses during the course of a clinical trial.

Friday, November, 02, 2001*

3:35 - 4:35 pm

206 Cox Hall

Refreshments will be served on the second floor of Dabney Hall (left of Room 222) at 3:00 pm.
*GSA seminar and pizza.