Site-less model helps to improve diversity in PREVUE-VALVE study


Researchers behind a trial to quantify the true prevalence of valvular heart disease within the USA say their use of cloud-based software has markedly boosted the diversity of the trial population, with the trial currently reaching over three times the average for target demographics compared to other research.  

The PREVUE-VALVE study is being led by the Cardiovascular Research Foundation (CRF) and investigators from the Columbia Presbyterian Medical Center (New York, USA), with participation from Hawthorne Effect, a company that specialises in decentralised clinical trials, University of Michigan (Ann Arbor, USA), Vanderbilt University Medical Center (Nashville, USA) and the retail health company CVS Health, and has been designed as a “site-less” clinical trial.

Around 5,000 participants aged 65–85 years, intended to be demographically representative of the US population, are expected to be enrolled in the study, and investigators expect to carry out a number of clinical assessments including in-home echocardiograms (ECG), 12-lead ECG, blood draws and quality of life assessments either in the patients’ home, at community practices or at retail sites, with an aim to reduce barriers and increase participation among traditionally underrepresented groups.

The study is supported by the Hawthorne Cloud software platform, a digital interface that delivers real-time clinical data from multiple sources. In addition to handling scheduling, equipment logistics and digital enrolment, the system’s algorithm links patients with a network of medical professionals carry out the assessments.

After the recruitment of over 1,000 participants in the trial, the organisers say that the study marks a “new standard for inclusive medicine”, with the recruitment for target demographics reportedly reaching more than three times the industry average when compared against figures from the Association of Clinical Research Professionals (ACRP).

This includes a recruitment of 15% African American individuals compared to the industry standard of <5%, 10% Hispanic compared to the industry standard of <1% and 3% Asian compared to the industry standard of 2%.

David Cohen

“This is a major accomplishment for the medical research industry,” said David Cohen, director of clinical and outcomes research at CRF, and an investigator in the trial. “For a disease that impacts so many in the USA., it is critical to gather data that are actually representative of our diverse population. With our partnership with Hawthorne Effect, CRF is paving the way for the development of advanced treatments to keep everyone healthy.”

“We have overcome decades-long challenges in clinical research with the PREVUE-VALVE study,” said Jodi Akin, founder and CEO of Hawthorne Effect. “With a single site of record, we enrolled a 500-patient pilot in less than four months that was nearly representative of the US population and captured data in a short time frame. In doing so, we are making clinical trials more accessible and convenient, and ultimately advancing research to get quality care to all patients faster.”


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