A novel test to compare two treatments based on endpoints involving both nonfatal and fatal events.

ABSTRACT: In a clinical trial comparing two treatment groups, one commonly-used endpoint is time to death. Another is time until the first nonfatal event (if there is one) or until death (if not). Both endpoints have drawbacks. The wrong choice may adversely affect the value of the study by impairing power if deaths are too few (with the first endpoint) or by lessening the role of mortality if not (with the second endpoint). We propose a compromise that provides a simple test based on the time to death if the patient has died or time since randomization augmented by an increment otherwise. The test applies the ordinary two-sample Wilcoxon statistic to these values. The formula for the increment (the same for experimental and control patients) must be specified before the trial starts. In the simples

SUBMITTER: Potthoff RF 

PROVIDER: S-EPMC4503508 | biostudies-literature | 2015 Jul-Aug

REPOSITORIES: biostudies-literature