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Peer-Reviewed Publication
Ann Behav Med2025;59(1)January 4, 2025Clinical Trial, Phase II

Mitigating fraud in a fully decentralized clinical trial of a digital health intervention.

Jessie B Moore1, Amy Chieng1, Maddison C Pirner2, Sarah Pajarito2, Erin A Vogel3, Molly A Bowdring1, Lauren Bullard2, Athena Robinson2, Judith J Prochaska1
1Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Palo Alto, CA, USA.
2Woebot Health, San Francisco, CA, USA.
3TSET Health Promotion Research Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.

Abstract

BACKGROUND: Decentralized clinical trials (DCT), digital survey methodologies, and health monitoring technologies create the potential to reduce study participant burden as well as enhance sample diversity and enrollment pace. However, fraudulent participant activity poses a significant threat to study validity and data integrity. PURPOSE: This study quantifies fraudulent attempts at participatio…

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