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Abstract Details

Activity Number: 319
Type: Topic Contributed
Date/Time: Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305516
Title: Repeated Confidence Bands for Under-Running or Over-Running Clinical Trials
Author(s): Lihui Zhao*+ and X. Joan Hu and Steve Lagakos
Companies: Northwestern University and Simon Fraser University and Harvard University
Address: , , ,
Keywords: Group sequential analysis ; Interim review ; Multiple comparisons ; Multiple end points ; Nonparametric inference ; Repeated confidence bands

Under-running or over-running clinical trials with pre-specified stopping criterion impose statistical challenges to type I error control and results interpretation. In some trials, the specific types and magnitudes of treatment group differences that would warrant early termination cannot easily be specified prior to the onset of the trial and/or could change as the trial progresses. This underscores the need for more flexible monitoring methods than traditional approaches. In this talk, we review the repeated confidence bands approach for interim monitoring, and present its extension to more general settings where there can be a multivariate response and/or multiple treatment arms, which are increasingly common in part because of their efficiency and a greater concern about balancing risks with benefits. We will discuss how the repeated confidence bands approach can be used for under-running or over-running clinical trials. We will illustrate the approach using the results of a recent AIDS clinical trial and examine its efficiency and robustness via simulation.

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