JMIR Publications

ABSTRACT

Background:

Virtually-conducted clinical trials have become an important tool for improving access to research. Online research gives rise to new avenues for potentially fraudulent actors to participate in studies to achieve monetary gain.

Objective:

We describe our experience of uncovering and removing fraudulent participants from a virtually-conducted research study and our methods to prevent fraudulent participants in the future.

Methods:

Fraudulent participation in two linked, online clinical trials was first uncovered in 2023. We describe the investigation and identification of additional fraudulent participants (falsified identity or information to meet eligibility criteria) who successfully enrolled in these trials. Our study team categorized indicators of suspicious activity at pre-screening, screening, and baseline stages of study participation and implemented a manual checklist method to prevent fraudulent participation. We discuss the effectiveness of our fraud prevention methods six months after the initial breach of the trials.

Results:

Prior to initial detection, ten fraudulent participants successfully enrolled in our trials. Following the implementation of new fraudulence preventive measures, 37 individuals were identified as fraudulent at the screening stage and no new fraudulent participants were enrolled. We provide a comprehensive list of suspicious behaviors that may suggest the virtual research intrusion of persons using fake identities.

Conclusions:

For online clinical studies, manual methods of fraud prevention, used in conjunction with automated prevention methods, can equip researchers to detect evolving patterns of attempted fraudulent enrollment. Clinical Trial: ClinicalTrials.gov NCT05503173 and NCT05505942