Protocol designed subgroup analyses in multiarmed clinical trials: multiplicity aspects.
Subgroup analyses are quite common in clinical trials although the subgroup findings are usually presented without adjustment for the multiple analyses, which increases the chance of false positive findings. This paper is focused on the multiplicity aspects of subgroup analyses in multiarmed randomized clinical trials and provides some guidance to practitioners.
Biometrics Department, NV Organon, Oss, The Netherlands. egbert.biesheuvel@organon.com
Egbert H E
EH
Biesheuvel
Ludwig A
LA
Hothorn
D005260:Female; D006801:Humans; D008297:Male; D015233:Models, Statistical; D015999:Multivariate Analysis; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*