This was for the Prevue-Valve clinical research study led by the Cardiovascular Research Foundation (CRF).
The interim recruitment results are especially remarkable because according to industry averages from the Association of Clinical Research Professionals, recruitment of patient demographics was exceeded. Setting the bar for a new standard of inclusiveness, the patients were 15% African American compared to the industry standard of less than 5%, 10% Hispanic compared to less than 1% and 3% Asian compared to the industry standard of 2%.
Despite recent efforts by the FDA to improve diversity in study samples, the clinical trial industry still faces major challenges with diverse patient recruitment and attrition. Black, Latinx, Native American and Asian populations represent 0.5% to <5% of study populations on average, despite representing far larger portions of the United States population.
Interventions for minority groups
These disparities lead to a research gap in understanding the efficacy of interventions for minority groups in the United States. The true modernization of medicine relies on diverse samples from the entry point: clinical trials. Hawthorne Effect has accomplished these goals by building platforms that prioritize inclusive patient recruitment and accessible trial execution.
"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 U.S. population and captured data in a short time frame. In doing so, we’re making clinical trials more accessible and convenient, and ultimately advancing research to get quality care to all patients faster.”
The study is supported by the Hawthorne Cloud software platform, that according to the company is an all-in-one digital interface that delivers real-time, validated and highly accurate clinical data from multiple sources.
The Hawthorne Heroes are a network of more than 4,000 highly trained medical professionals who can meet with patients wherever they are – from in their homes to community practices to retail sites. The platform’s intelligent algorithm can link patients with Heroes who can perform a battery of clinical assessments including in-home echocardiograms (ECG), 12-lead ECG, blood draws and quality of life assessments. This in turn reduces barriers and increases participation for traditionally underrepresented populations.
The Prevue-Valve study aims to quantify the true prevalence of VHD in a demographic representative sample of the US population. The company says that as populations age worldwide, heart ailments like VHD are increasing, but many patients suffer from delayed or otherwise deficient care despite new and effective therapies.
Detection and diagnosis of VHD is critical to successful treatment Hawthorne says and the Prevue-Valve study was established to correctly determine prevalence and aid healthcare providers in treating VHD at the best possible time. The study aims to be concluded with the publication of the main results by 2025.
David Cohen, director of clinical and outcomes research at CRF, said: “This is a major accomplishment for the medical research industry.
“For a disease that impacts so many in the U.S., 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.”
Since launching in 2015, Hawthorne Effect has conducted 76 trials of varying complexities, a portion of which were able to be executed during COVID-19 lockdowns by going to patients’ households.