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Stat Med. 2011 Jun 15;30(13):1473-88. doi: 10.1002/sim.4008. Epub 2011 Apr 18.

Mixtures of multiple testing procedures for gatekeeping applications in clinical trials.

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Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA.


This paper proposes a general framework for constructing gatekeeping procedures for clinical trials with hierarchical objectives. Such problems frequently exhibit complex structures including multiple families of hypotheses and logical restrictions. The proposed framework is based on combining multiple procedures across families. It enables the construction of powerful and flexible gatekeeping procedures that account for general logical restrictions among the hypotheses of interest. A clinical trial in patients with schizophrenia is used to illustrate the approach for parallel gatekeeping, whereas another clinical trial in patients with hypertension is used to illustrate the approach for gatekeeping with general logical restrictions.

[Indexed for MEDLINE]

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