Tonix Pharmaceuticals Holding Corp.
RANDOMIZATION HONORING METHODS TO ASSESS THE SIGNIFICANCE OF INTERVENTIONS ON OUTCOMES IN DISORDERS

Abstract:

Systems and methods for an analysis of clinical trial data using randomization tests that honors the randomized design of the clinical trial are provided herein. In particular, a non-parametric analyzer implementing randomization tests and associated methods for analyzing clinical data is provided. The non-parametric analyzer receives clinical trial data comprising a data structure containing data corresponding to subjects in the clinical trial, where the subjects have been organized into treatment groups, including at least one control group. The non-parametric analyzer generates multiple treatment allocations of the data structure by reorganizing, at random, the subjects along with corresponding data to generate further groups. In some embodiments, the non-parametric analyzer determines the statistical significance based on an overall probability and the multiple allocations of the data structure. The overall probability may be generated via a combination analysis for comparing test statistics between groups of the data structure and the multiple allocations.