Super Chain Procedures in Clinical Trials

• Activity Number: 447
• Type: Topic Contributed
• Date/Time: Wednesday, August 1, 2012 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): George Kordzakhia*+ and Alex Dmitrienko
• Companies: FDA and Quintiles, Inc.
• Keywords: multiple comparison ; primary endpoints ; key secondary endpoints ; type I error rate

Abstract

We introduce a new class of multiple testing procedures for addressing multiplicity problems arising in clinical trials with multiple objectives grouped into families. The families may correspond to equally important sets of objectives, e.g., co-primary endpoints, or ordered sets of objectives, e.g., primary and secondary endpoints. The procedures, termed super chain procedures, serve as an extension of several classes of other multiple testing procedures, including chain procedures and parallel gate keeping procedures.

Super chain procedures exhibit several features, including flexible decision rules that can be tailored to a broad class of win criteria in confirmatory clinical trials. Additionally, super chain procedures enable the trial's sponsor to incorporate available distributional information in order to improve overall power.

This is the joint work with Alex Dmitrienko

Disclaimer: This presentation reflects the views of the authors and should not be construed to represent FDA's views or policies