Skip Navigation
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

National Institute of Environmental Health Sciences

Use this QR code to view the newest version of this document
Use this QR code to view the newest version of this document

Your Environment. Your Health.

Publication Detail

Title: Design and analysis of biomarker-integrated clinical trials with adaptive threshold detection and flexible patient enrichment.

Authors: Wang, Ting; Wang, Xiaofei; George, Stephen L; Zhou, Haibo

Published In J Biopharm Stat, (2020 Nov 01)

Abstract: We propose a new adaptive threshold detection and enrichment design in which the biomarker threshold is adaptively estimated and updated by optimizing a trade-off between the size of the biomarker positive population and the magnitude of the treatment effect in that population. Enrichment is based on an enrollment criterion that accounts for the uncertainty in estimation of the threshold. Early termination for futility is allowed based on predictive success probability. Valid testing and estimation techniques for the treatment effect overall and inpatient subgroups are studied. Simulations and an example demonstrate advantages of the proposed design over existing designs.

PubMed ID: 33175640 Exiting the NIEHS site

MeSH Terms: Biomarkers; Clinical Trials as Topic*; Humans; Probability; Research Design*

Back
to Top