A Test for Multiple Binary Endpoints with Continuous Latent Distribution in Clinical Trials

A combined score test for binary and ordinal endpoints from clinical trials.

There is growing interest, especially for trials in stroke, in combining multiple endpoints in a single clinical evaluation of an experimental treatment. The endpoints might be repeated evaluations of the same characteristic or alternative measures of progress on different scales. Often they will be binary or ordinal, and those are the cases studied here. In this paper we take a direct approach...

Analysis of Multiple Endpoints in Clinical Trials

Most human diseases are characterized by multidimensional etiology and the efficacy of an experimental treatment frequently needs to be assessed on multiple outcome measures — commonly referred to as endpoints. There is a variety of ways in which the contribution of each endpoint can be accounted for in the primary analysis, for example, the trial’s sponsor can treat endpoints as independent en...

Adaptive designs for clinical trials with multiple endpoints

Rationale for adaptive designs with multiple endpoints In clinical trials, the efficacy of a new treatment is usually assessed by a single primary endpoint [1,2]. Other important aspects concerning the new treatment, such as adverse events or quality of life, are taken into account by the definition of secondary endpoints. Usually, only the primary endpoint is analyzed confirmatorily with a sta...

Some statistical methods for multiple endpoints in clinical trials.

This paper summarizes, defines, and discusses multiple endpoints comparison procedures, concepts, and methodologies for applications to clinical trials. We address the more widely used methods of alpha-level, p-value, and critical value adjustments. We examine global assessment measures such as O'Brien's test and Simes' procedure and contrast them with the alpha-adjustment procedures of Bonferr...

- - - - - - - Bayesian Analysis of Latent Trait Hierarchical Models for Multiple Binary Outcomes in Cluster Randomized Clinical Trials