P102: From Site-Centric to Patient-Centric? Measuring Inclusion in Decentralized Trials
Poster Presenter
Faith Butta
MS Clinical Research and Product Development
University of North Carolina Wilmington United States
Objectives
To evaluate the association between decentralized trial design and geographic inclusion in Phase III U.S. interventional studies since 2015.
Method
A cross-sectional analysis of Phase III U.S.-based interventional trials registered on ClinicalTrials.gov (2015–2025) was conducted. Study site ZIP codes will be mapped and categorized using rural–urban classification frameworks. Outcomes include rural site representation and geographic dispersion.
Results
After classifying trials (n=7019) as DCT or traditional based on their brief summary terminology, study site zipcodes were mapped using a rural-urban classiifcation framework. Outcomes include rural site representation and geographic dispersion. Preliminary results show that although DCT utilization has increased, site clustering remains predominantly metropolitan. Partially decentralized trials demonstrate some geographic expansion, while fully decentralized models show greater dispersion but limited overall adoption.
Conclusion
Preliminarily, decentralization alone does not ensure geographic equity as additional barriers still remain. Operational site strategy must intentionally align with patient-centric design to meaningfully expand trial access.
