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Randomization for small clinical trials

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Design and Analysis of Experiments

Rare disease clinical trials present unique problems for the statistician designing the study. First, the trial may be small to reflect the uniquely small population of diseased in the population. Hence, the usual large sample beneficial properties of randomization (balancing on unknown covariates, distribution of standard tests, converging to a target allocation) may not apply. We describe the impact of such trials on consideration of randomization procedures, and discuss randomization as a basis for inference. We conclude that, in small trials, the randomization procedure chosen does matter, and randomization tests should be used as a matter of course due to its property of preserving the type I error rate under time trends.

This talk is part of the Isaac Newton Institute Seminar Series series.

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