Abstract
AbstractThe state of the art and science of clinical trials has reached a new level of sophistication with the joint advent of microelectronic monitoring devices and the development of new statistical approaches to integrate compliance data into dose-response models. Consideration of compliance can reduce the risk of Type 2 errors. In addition, sub-group analyses could be used to enhance a claim for efficacy in the fully compliant group. In more elaborate analyses, compliance data can be used as a co-variable with major endpoints. these advances in compliance assessment should be incorporated in clinical trials of all phases and sizes.
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