Adaptive group sequential confidence intervals for the ratio of normal means

dc.contributor.authorHartung, Joachim
dc.contributor.authorKnapp, Guido
dc.date.accessioned2009-02-02T10:41:10Z
dc.date.available2009-02-02T10:41:10Z
dc.date.issued2009-02-02T10:41:10Z
dc.description.abstractIn controlled group sequential trials, we consider the ratio of normal means as the effect measure of interest and derive group sequential nested confidence intervals on this parameter. In an interim analysis, the sample sizes of the following stages can be determined in a completely adaptive way using the unblinded data from all previously performed stages. Despite the data-dependent adaptation, the nested confidence intervals always keep the predefined confidence coefficient. Using nested confidence intervals, we make test decisions either in noninferiority or in superiority trials. However, in an interim analysis, we can change the planning from showing noninferiority to showing superiority or vice versa without affecting the predefined confidence coefficient of the nested intervals. A real data example is worked out in detail and the change in the planning from showing superiority to showing noninferiority is shown during the ongoing trial.en
dc.identifier.urihttp://hdl.handle.net/2003/26011
dc.identifier.urihttp://dx.doi.org/10.17877/DE290R-517
dc.language.isoen
dc.subjectadaptive sample size planningen
dc.subjectgroup sequential clinical trialsen
dc.subjectratio of meansen
dc.subjectswitching between noninferiority and superiorityen
dc.subject.ddc310
dc.titleAdaptive group sequential confidence intervals for the ratio of normal meansen
dc.typeText
dc.type.publicationtypepreprint
dcterms.accessRightsopen access

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