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Abstract Details
Activity Number:
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559
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 3, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Section on Government Statistics
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Abstract - #301110 |
Title:
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Subgroup Analysis: Guidelines for Department of Veterans Affairs Clinical Trials
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Author(s):
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Robert Lew*+ and Ying Lu and Mei-Chiung Shih and Grant Huang
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Companies:
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VA Boston Cooperative Studies Program Coordinating Center and Palo Alto VA CSP Coordinating Center/Stanford and Veterans Administration and Veterans Administration
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Address:
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150 S. Huntington Avenue, Boston, MA, , U.S.A.
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Keywords:
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subgroup analysis ;
type I error ;
policy guidelines
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Abstract:
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The VA has done over 500 multicenter clinical trials drawing most subjects from the millions of US veterans cared for at VA facilities. The typical trial primary hypothesis has 90% power and a 5% Type I error. Subgroup analyses are exploratory because the sample size adequate to power all of them would make the trial infeasible. Thus, what is a fair level of Type I error for subgroup analyses? We propose guidelines that would: 1) pre-specify a list of subgroup analyses, 2) require analytic reports to reference the primary and other pertinent results based on the primary data, and 3) set the level below 5% but above the Bonferroni level. The pre-specified list would include hypotheses in the proposal and those recommended by the DMC during the trial and by disinterested experts. We discuss approaches to Type I error that account for correlation among the test statistics associated with a set of hypotheses; Efron's method to control for the false discovery rate, Simon's empirical Bayes method for clinical trials, and Bayesian subgroup analysis methods. Adherence to such guidelines would refine secondary analyses, inter-relate conclusions, and clarify the import of major results.
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