Simultaneous inference on treatment effects in survival studies with factorial designs.

ABSTRACT: A clinical trial with a 2×2 factorial design involves randomization of subjects to treatment A or A‾ and, within each group, further randomization to treatment B or B‾. Under this design, one can assess the effects of treatments A and B on a clinical endpoint using all patients. One may additionally compare treatment A, treatment B, or combination therapy AB to A‾B‾. With multiple comparisons, however, it may be desirable to control the overall type I error, especially for regulatory purposes. Because the subjects overlap in the comparisons, the test statistics are generally correlated. By accounting for the correlations, one can achieve higher statistical power compared to the conventional Bonferroni correction. Herein, we derive the correlation between any two (stratified or unstratified

SUBMITTER: Lin DY 

PROVIDER: S-EPMC5026867 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature