Monitoring a clinical trial with multiple hypotheses concerning the treatment effect on a single primary endpoint.
In a number of clinical trials there is interest in testing more than one hypothesis concerning the treatment effect on a single primary endpoint. For instance, a sponsor of a trial to demonstrate that a test treatment (T) is non-inferior to an active control (R) may also be interested in showing that T is superior to R, if this is the case. Using the closed testing method for constructing tests of multiple hypotheses which control the multiple level of significance, we provide a framework for testing these hypotheses sequentially during a trial at pre-planned interim analyses.
Denne
J S
JS
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA.
Koch
G G
GG
D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D012107:Research Design; D013223:Statistics as Topic / Q000379:methods*