Measuring the Impact of DCT Solutions Use on Clinical Trial Enrollment Diversity

Abstract Background: Whereas anecdotal reports suggest that the use of decentralized clinical trial (DCT) solutions can improve access, equity and inclusion 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 in order to compare and contrast participant diversity in trials which included various DCT solutions. Results: The results show that the use of DCT solutions is associated with higher levels of racial and ethnic diversity, however the impact is not uniform across all DCT solutions. Specifically, the use of local labs was significantly associated with higher observed diversity in clinical trials, whereas the use of virtual visits and televisits was associated with lower enrollment diversity.