A two‐stage group‐sequential design for delayed treatment responses with the possibility of trial restart
Stephen Schüürhuis,
Frank Konietschke,
Cornelia Ursula Kunz
Abstract:Common statistical theory applicable to confirmatory phase III trial designs usually assumes that patients are enrolled simultaneously and there is no time gap between enrollment and outcome observation. However, in practice, patients are enrolled successively and there is a lag between the enrollment of a patient and the measurement of the primary outcome. For single‐stage designs, the difference between theory and practice only impacts on the trial duration but not on the statistical analysis and its interpr… Show more
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