Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials

Zachary Smith; Kenneth Getz

doi:10.1007/s43441-024-00659-w

Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials

Ther Innov Regul Sci. 2024 May 11. doi: 10.1007/s43441-024-00659-w. Online ahead of print.

Authors

Zachary Smith¹, Kenneth Getz²

Affiliations

¹ Tufts Center for the Study of Drug Development, Tufts University, Boston, USA. zachary.smith605922@tufts.edu.
² Tufts Center for the Study of Drug Development, Tufts University, Boston, USA.

PMID: 38734837
DOI: 10.1007/s43441-024-00659-w

Abstract

Background: Whereas anecdotal reports suggest that the use of decentralized clinical trial (DCT) solutions can improve participant diversity in clinical trials there is no quantitative evidence to support such reports.

Methods: Tufts CSDD conducted this initial study based on data collected from prior research and publicly available data drawn from Clinicaltrials.gov to compare and contrast participant diversity in trials which included various DCT solutions - virtual visits or televisits, home visits, devices or wearables, and the use of local labs.

Results: The results of this analysis indicate that the use of local labs is associated with a lower percentage of white participants; the use of virtual visits or televisits is associated with a lower percentage of Black participants; and the use of devices or wearables was not associated with any significant change in participant demographics. The use of home visits could not be tested for significant differences.

Keywords: Clinical trial diversity; DCT; Representation.