Adaptive Designs for Dose-Ranging Studies

• Activity Number: 598
• Type: Invited
• Date/Time: Thursday, August 5, 2010 : 8:30 AM to 10:20 AM
• Sponsor: ENAR
• Author(s): Vladimir Dragalin*+
• Companies: Pfizer Inc.
• Keywords: adaptive designs ; dose-ranging studies ; response-adaptive allocation ; stopping rules ; simulations

Abstract

The overall goal of dose-ranging studies is to establish the existence, nature and extent of dose effect. Recently, a great effort has been made to investigate and develop designs and methods for efficient learning about dose response and more accurate and faster decision making on dose selection and improved labeling. The focus is on adaptive and model-based dose-ranging designs. In this presentation, I will compare the performance of the different adaptive designs in learning about and estimating the dose response relationship. The evaluation of statistical operational characteristics of these new adaptive designs has been mainly done through comprehensive simulation studies. There is a need for new theoretical developments in the methodology for planning, monitoring and analysis for these sequential designs.