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A Novel Approach To Enhance The Enrollment Of Under-represented Groups In Clinical Trials Using A Site Selection Tool
Vikram S. Kashyap, MD1, Jeff Yoder, MS
2, James Wadzinski
2, Daniel J. Bertges, MD
3, Jens Eldrup-Jorgensen, MD
4.
1Corewell Health, Grand Rapids, MI, USA,
2Vascular Quality Inititative, Rosemont, IL, USA,
3University of Vermont Medical Center, Burlington, VT, USA,
4Maine Medical Center, Portland, ME, USA.
OBJECTIVES: The selection of clinical sites is a key step in starting a clinical trial. Usually, site selection is based on a survey that is subjective, anecdotal, does not mirror eventual enrollment, and historically has led to low participation of women and minorities in vascular trials. We describe a novel site selection tool (SST) and its possible application in clinical trials.
METHODS: The SST used the SVS Patient Safety Organization, a national registry of deidentified vascular surgery data, to select diverse sites that would have high clinical volume and enrollment of under-represented cohorts for a planned trial of anti-platelet therapy after PVI (Peripheral Vascular Intervention). We assessed sites using the PVI module based on 2014 data and chose top quartile sites for multiple variables including clinical volume, female, and Black patients. We compared 3 time periods: complete year 2014 to 2016 and 2018 data. All analyses were performed in RStudio (version RStudio 2023.06.1+524) running R (version 4.2.2). Institutional Review Board approval and informed consent requirements were not necessary as the data were deidentified.
RESULTS: Out of over 390 VQI active sites enrolling patients into the PVI registry, 61 consistently performed 100 or more PVI procedures. The top quartile sites in 2014 had volume of 315 PVI procedures, 81% long-term follow-up, and 44% female
. High volume sites consistently had high volume over time and sites with high enrollment of Black patients also stayed stable (Figure. Box and whisker plot of Black patient enrollment. Top quartile mean—dashed line; individual top quartile sites—red scatter plot). However, other variables including Hispanic patient % were less consistent and sites with initially high female enrollment regressed to the mean.
CONCLUSIONS: The SST provides granular, longitudinal verified data on sites performing PVI. This tool can be used predictively to recruit sites that can have robust enrollment of historically under-represented groups in a clinical trial.
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