Abstract:
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It is inevitable to face a multiplicity issue in many clinical trials. While this issue is less important for earlier phase exploratory clinical studies, it is critical for adequate and well-controlled clinical trials due to the confirmatory nature of the trials and the fact that regulatory decision is made primarily based on the evidence from them. Sources of multiplicity include, but are not limited to: multiple endpoints, multiple doses, multiple looks, multiple time-points, multiple analysis methods, multiple subgroups, etc. It is not always clear when it is necessary to adjust for multiplicity and when it is not. This talk will first introduce the multiplicity issue and concerns on it, and then focus on the consideration on whether there is a need for adjustment from a regulatory perspective. Hypothetical examples are used to assist the discussions.
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