A three-arm clinical trial design with an experimental treatment, an active control, and a placebo control, commonly referred to as the gold standard design, enables testing of non-inferiority or superiority of the experimental treatment compared with the active control. In this paper, we propose methods for designing and analyzing three-arm trials with negative binomially distributed endpoints...

Elliott and Müller (2006) considered the problem of testing for general types of parameter variations, including infrequent breaks. They developed a framework that yields optimal tests, in the sense that they nearly attain some local Gaussian power envelop. The main ingredient in their setup is that the variance of the process generating the changes in the parameters must go to zero at a fast r...

This paper grew out of a lecture presented at the 54th Session of the International Statistical Institute in Berlin, August 13 20, 2003, Schneeweiss (2003). It intends not only to outline the eventful life of Abraham Wald (1902 1950) in Austria and in the United States but also to present his extensive scientific work. In particular, the two main subjects, where he earned most of his fame, are ...

The likelihood ratio spatial scan statistic has been widely used in spatial disease surveillance and spatial cluster detection applications. In order to better understand cluster mechanisms, an equivalent model-based approach is proposed to the spatial scan statistic that unifies currently loosely coupled methods for including ecological covariates in the spatial scan test. In addition, the uti...

There is a growing literature on unit root testing in threshold autoregressive models. This paper makes two contributions to the literature. First, an asymptotic theory is developed for unit root testing in a threshold autoregression, in which the errors are allowed to be dependent and heterogeneous, and the lagged level of the dependent variable is employed as the threshold variable. The asymp...

In this paper we introduce three natural “score statistics” for testing the hypothesis that F (t0) takes on a fixed value in the context of nonparametric inference with current status data. These three new test statistics have natural intepretations in terms of certain (weighted) L2 distances, and are also connected to natural “one-sided” scores. We compare these new test statistics with an ana...

Group Randomized Trials (GRTs) randomize groups of people to treatment or control arms instead of individually randomizing subjects. When each subject has a binary outcome, over-dispersed binomial data may result, quantified as an intra-cluster correlation (ICC). Typically, GRTs have a small number, bin, of independent clusters, each of which can be quite large. Treating the ICC as a nuisance p...

We consider the problem of calculating power and sample size for tests based on generalized estimating equations (GEE), that arise in studies involving clustered or correlated data (e.g., longitudinal studies and sibling studies). Previous approaches approximate the power of such tests using the asymptotic behavior of the test statistics under fixed alternatives. We develop a more accurate appr...

BACKGROUND The area under the receiver operating characteristic (ROC) curve, referred to as the AUC, is an appropriate measure for describing the overall accuracy of a diagnostic test or a biomarker in early phase trials without having to choose a threshold. There are many approaches for estimating the confidence interval for the AUC. However, all are relatively complicated to implement. Furthe...