Elsevier

Journal of Biomedical Informatics

Volume 57, October 2015, Pages 145-162
Journal of Biomedical Informatics

A privacy preserving protocol for tracking participants in phase I clinical trials

https://doi.org/10.1016/j.jbi.2015.06.019Get rights and content
Under a Creative Commons license
open access

Highlights

  • We present a privacy-preserving protocol to detect concurrent trial participants.

  • We present a name representation scheme resilient to frequency attacks.

  • The accuracy of the protocol is similar to standard non-secure methods.

  • For a database size of 20,000, the private query time is under 40 s on 32 cores.

Abstract

Objective

Some phase 1 clinical trials offer strong financial incentives for healthy individuals to participate in their studies. There is evidence that some individuals enroll in multiple trials concurrently. This creates safety risks and introduces data quality problems into the trials. Our objective was to construct a privacy preserving protocol to track phase 1 participants to detect concurrent enrollment.

Design

A protocol using secure probabilistic querying against a database of trial participants that allows for screening during telephone interviews and on-site enrollment was developed. The match variables consisted of demographic information.

Measurement

The accuracy (sensitivity, precision, and negative predictive value) of the matching and its computational performance in seconds were measured under simulated environments. Accuracy was also compared to non-secure matching methods.

Results

The protocol performance scales linearly with the database size. At the largest database size of 20,000 participants, a query takes under 20 s on a 64 cores machine. Sensitivity, precision, and negative predictive value of the queries were consistently at or above 0.9, and were very similar to non-secure versions of the protocol.

Conclusion

The protocol provides a reasonable solution to the concurrent enrollment problems in phase 1 clinical trials, and is able to ensure that personal information about participants is kept secure.

Keywords

Clinical trial
Phase 1 volunteer
Secure multi-party computation

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