Work

Two-stage adaptive enrichment design for testing an active factor

Year: 2019

Type: article

Abstract: We propose an adaptive enrichment approach to test an active factor, which is a factor whose effect is non-zero in at least one subpopulation. We implement a two-stage play-the-winner design where all subjects in the second stage are enrolled from the subpopulation that has the highest observed effect in the first stage. We recommend a weighted Fisher's combination of the most powerful test for each stage, respectively: the first stage Hotelling's test and the second stage noncentral chi-square test. The test is further extended to cover binary outcomes and time-to-event outcomes.

Source: Journal of Biopharmaceutical Statistics

DOI: 10.1080/10543406.2019.1609015

Authors: A. Adam Ding, Samuel S. Wu, Natalie E. Dean, Rachel S. Zahigian

Institutions: Northeastern University, University of Florida

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: green

Funders: National Institute on Aging, National Institute of Allergy and Infectious Diseases