JSM 2012 Home

JSM 2012 Online Program

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

Online Program Home

Abstract Details

Activity Number: 556
Type: Topic Contributed
Date/Time: Wednesday, August 1, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304008
Title: Gatekeeping Procedures in Complex Multiplicity Problems in Clinical Trials
Author(s): Olga V Marchenko*+ and Alex Dmitrienko
Companies: Quintiles, Inc. and Quintiles, Inc.
Address: 5927 South Miami Boulevard, Morrisville, NC, , USA
Keywords: Clinical trials ; Multiple testing procedures ; Type I error rate ; Power ; Powerful gatekeeping procedures

This presentation discusses solutions to complex multiplicity problems arising in confirmatory clinical trials with multiple families of objectives (for example, primary and secondary endpoints). The solutions are based on a class of multiple testing procedures known as gatekeeping procedures. Gatekeeping procedures have attracted much attention in clinical drug development due to the regulatory requirement to protect the Type I error rate across multiple families. The presentation provides an overview of regulatory requirements and introduces a general process for building gatekeeping procedures. The process utilizes logical relationships among the objectives and all available distributional information to build flexible and powerful gatekeeping procedures. Optimal gatekeeping procedures are selected from a set of candidate procedures based on application-specific criteria. The development process is illustrated using a clinical trial with a "three-dimensional" multiplicity problem based on multiple endpoints, dose-placebo comparisons and timepoints.

The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.

Back to the full JSM 2012 program

2012 JSM Online Program Home

For information, contact jsm@amstat.org or phone (888) 231-3473.

If you have questions about the Continuing Education program, please contact the Education Department.