Department of Biostatistics Seminar/Workshop Series

Estimating Covariate-Adjusted Log Hazard Ratios in Randomized Clinical Trials using Cox Proportional Hazards Models and Nonparametric Randomization Based Analysis of Covariance

Ben Saville, PhD

Assistant Professor, Department of Biostatistics, Vanderbilt University School of Medicine

Wednesday, March 28, 1:30-2:30pm, MRBIII Room 1220

In the context of randomized clinical trials with time-to-event outcomes, estimates of covariate-adjusted log hazard ratios for comparing two treatments are obtained via nonparametric analysis of covariance by forcing the difference in means for covariables to zero. The method avoids the assumption of proportional hazards for each of the covariates, and it provides an adjusted analysis for the same population average treatment effect which the unadjusted analysis addresses. It is primarily useful in regulatory clinical trials that require analyses to be specified a priori. To illustrate, the method is applied to a study of lung disease with multivariate time-to-event outcomes.