Two-sample post-stratified or subgroup analysis with restricted randomization rules |
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Authors: | Charles S Davis |
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Institution: | Department of Preventive Medicine , University of Iowa , Division of Biostatistics |
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Abstract: | In a clinical trial to compare two treatments, subjects may be allocated sequentially to treatment groups by a restricted randomization rule. Suppose that at the end of the trial, the investigator is interested in a post-stratified or subgroup analysis with respect to a particular demographic or clinical factor which was not selected prior to the trial for stratified randomization. Under a randomization model, large sample theory of two-sample post-stratified permutational tests is developed with a broad class of restricted randomization treatment allocation rules. The test procedures proposed here are illustrated with a real-life example. The results of this example indicate that it is not always possible to ignore the treatment rule used in the trial in the design-based analysis. |
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Keywords: | Biased coin design urn design post-stratification randomization model subgroup analysis |
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