A prediction interval for the population-wise error rate

Abstract: We construct an asymptotic prediction interval for the population-wise error rate (PWER), which is a multiple type I error criterion for clinical trials with overlapping patient populations. The PWER is the probability that a randomly selected patient will receive an ineffective treatment. It must usually be estimated due to unknown population strata sizes, such that only an estimate can be controlled at the given significance level. We apply the delta method to find a prediction interval for the resulting true PWER, we demonstrate by simulations that the interval has the required coverage probability, and illustrate the approach with real data examples.