Monitoring clinical trials with multiple arms.
In order to benefit from the substantial overhead expenses of a large group sequential clinical trial, the simultaneous investigation of several competing treatments becomes more popular. If at some interim analysis any treatment arm reveals itself to be inferior to any other treatment under investigation, this inferior arm may be or may even need to be dropped for ethical and/or economic reasons. Recently proposed methods for monitoring and analysis of group sequential clinical trials with multiple treatment arms are compared and discussed. The main focus of the article is on the application and extension of (adaptive) closed testing procedures in the group sequential setting that strongly control the familywise error rate. A numerical example is given for illustration.
Hellmich
M
M
Department of Medical Statistics, Informatics and Epidemiology, University of Cologne, Germany. martin.hellmich@medizin.uni-koeln.de
D001699:Biometry; D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*; D006801:Humans; D015233:Models, Statistical