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Multiplicity Issues in Clinical Trials JSM 2011

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Selected presentations given at Joint Statistical Meetings in Miami, FL on July 31-August 4, 2011.

Topic-contributed presentations

Multistage gatekeeping procedure with retesting

Presented by George Kordzakhia, Office of Biostatistics, Office of the Translational Sciences, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (jointly with Alex Dmitrienko, Eli Lilly and Company).

This talk introduces a general method for constructing multistage parallel gatekeeping procedures with a retesting option. This approach serves as an extension of general multistage parallel gatekeeping procedures (Dmitrienko, Tamhane and Wiens, 2008) and parallel gatekeeping procedures with retesting for two-family problems (Dmitrienko, Kordzakhia, and Tamhane, 2011). It was shown in the latter paper that power of parallel gatekeeping procedures can be improved by adding an additional retesting stage which enables retesting of the primary null hypotheses using a more powerful component procedure than the original procedure if all secondary null hypotheses are rejected. The new method enables clinical trial researchers to construct a class of more general multistage parallel gatekeeping procedures with retesting. The new procedures support multiple retesting of the primary and secondary families and do not require all secondary null hypotheses be rejected.

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Invited presentations

Multiple testing with complex hierarchical structures in clinical trials

Presented by Alex Dmitrienko, Research Advisor, Eli Lilly and Company (jointly with Ajit C. Tamhane, Northwestern University).

This talk discusses approaches to addressing multiplicity issues in clinical trials with multiple objectives. The objectives define multiple testing problems with complex hierarchical structures, eg, problems with null hypotheses grouped into multiple families with general logical relationships. A new method has been developed for defining multiple testing procedures for problems with multiple families of null hypotheses (termed gatekeeping procedures). The method is based on constructing mixtures of procedures used in individual families, including p-value-based and parametric procedures, and is termed the mixture-based method. Resulting gatekeeping procedures account for arbitrary logical relationships and control the familywise error rate in the strong sense. This general method is illustrated using clinical trials with multiple objectives, including multiple dose-placebo comparisons/patient populations and multiple dose-placebo comparisons/noninferiority-superiority tests.

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Weighted multiple comparison procedures for clinical trials

Presented by Brian L. Wiens, Director, Biostatistics and Data Management, Alcon Laboratories (jointly with Alex Dmitrienko, Eli Lilly and Company).

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