Validity of the Hochberg Procedure Revisited for Clinical Trial Applications
*Mohammad F. Huque, CDER/FDA 


There is much interest in using the Hochberg procedure (HP) for tests on primary endpoints of confirmatory clinical trials. The procedure is simple-to-use and enjoys more power than the Bonferroni and the Holm procedures. However, the HP is not assumption free like the other two procedures. It controls the familywise Type I error rate (FWER) when test statistics (used for statistical tests) are independent or if dependent satisfy a conditionally independent formulation. Otherwise, its properties for dependent tests at present are not fully understood. Confirmatory trials for statistical tests normally use simple test statistics, such as the normal Z, student’s t, and chi-square. The literature does include some work on the HP for dependent cases covering these test statistics, but concerns remain regarding its use for confirmatory trials for which endpoint tests are mostly of the dependent kind. The purpose of this presentation is therefore to revisit this procedure and provide some clarity for better understanding of its performance for dependent cases.