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Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials
1Tufts Center for the Study of Drug Development, Tufts University, Boston, USA. zachary.smith605922@tufts.edu.
Therapeutic Innovation & Regulatory Science
|May 11, 2024
Summary
Decentralized clinical trial (DCT) solutions show promise for improving clinical trial diversity. Local labs and virtual visits were associated with lower percentages of white and Black participants, respectively.
Area of Science:
- Clinical Research
- Health Equity
- Medical Informatics
Background:
- Anecdotal evidence suggests decentralized clinical trial (DCT) solutions enhance participant diversity.
- Quantitative data supporting the impact of DCTs on diversity is lacking.
Purpose of the Study:
- To quantitatively assess the association between DCT solutions and participant diversity in clinical trials.
- To identify specific DCT components that may influence demographic representation.
Main Methods:
- Analysis of data from prior research and ClinicalTrials.gov.
- Comparison of participant diversity across trials utilizing virtual visits, home visits, devices/wearables, and local labs.
Main Results:
- Local labs correlated with a reduced percentage of white participants.
- Virtual visits/televisits correlated with a reduced percentage of Black participants.
- Devices/wearables showed no significant demographic impact; home visits were not testable.
Conclusions:
- Certain DCT solutions, such as local labs and virtual visits, are associated with improved diversity in clinical trial populations.
- Further research is needed to explore the full impact of DCTs on equitable participant representation.
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