Utility of Adaptive Design Software in Practical Implementation

• Activity Number: 216
• Type: Invited
• Date/Time: Monday, August 1, 2011 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Gernot Wassmer*+
• Companies: ADDPLAN, GmbH
• Keywords: Adaptive designs ; Group sequential test ; Software

Abstract

Adaptive confirmatory designs refer to statistical designs that allow data-driven design changes whilst controlling the overall Type I error rate. As indicated in the draft guidance on "Adaptive Design Clinical Trials for Drugs and Biologics" the most important applications of these designs are sample size reassessment procedures, treatment arm selection procedures, and patient enrichment designs. Essentially, they can be regarded as a generalization of group sequential designs where data-driven design changes and more general applications are not foreseen. In this talk we review software products that allow the performance of confirmatory adaptive designs in terms of designing them, simulate their operation characteristics, and doing concrete analyses. Particularly, we discuss their applicability to specific adaptive designs requirements. This will extend the overview supplied in Wassmer and Vandemeulebroecke (Biometrical Journal, 2006) taking into account the current rapid development of methodological research in this area and the corresponding need for appropriate software.