October 10, 2023 — Hawthorne Effect, a complete clinical trials solution, announced interim recruitment results for the PREVUE-VALVE study, a clinical research study led by the Cardiovascular Research Foundation (CRF), that aims to quantify the prevalence of valvular heart disease (VHD). To date, Hawthorne Effect has successfully recruited over 1,000 patients in 48 states plus Hawaii. Patient recruitment also exceeded industry averages according to findings from the Association of Clinical Research Professionals for the below patient demographics, setting a new standard for inclusiveness:
15% African American compared to the industry standard of <5%
10% Hispanic compared to the industry standard of <1%
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. 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 a platform that prioritizes 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, an all-in-one digital interface that delivers real-time, validated and highly accurate clinical data from multiple sources. In addition to handling scheduling, equipment logistics and digital enrollment, its intelligent matching algorithm links patients with Hawthorne Heroes, a network of 4,000+ highly-trained medical professionals, who meet the patients where they are, whether it be in their homes, community practices or retail sites. Heroes 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 United States population. In addition to Hawthorne Effect and CRF, collaborators include Columbia University, CVS Caremark, University of Michigan, Vanderbilt University Medical Center and retail health partners CVS Health. 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. 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.
“This is a major accomplishment for the medical research industry,” said Dr. David Cohen, director of clinical and outcomes research at CRF. “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. To learn more about Hawthorne Effect and its modern clinical trials solutions, please visit https://hawthorne-effect.com/.
The study is being conducted in a sample of older individuals (i.e., age 65-85 years) that is representative of the U.S. population. The sample will be carefully curated to ensure traditionally underrepresented individuals are included and overrepresented, if possible. For more information on the methodology, visit https://classic.clinicaltrials.gov/ct2/show/NCT05357404.
About Hawthorne Effect
Hawthorne Effect is a complete clinical trials solution integrating technology and people to transform the clinical trials industry. Its technology-enabled platform and distributed network of certified medical professionals, Hawthorne Heroes, enable patients and clinicians to participate in trials within their trusted community. Its solution accelerates clinical research and generates evidence that makes clinical trials accessible and convenient while delivering meaningful and high-quality clinical assessments. Since launching in 2015, Hawthorne Effect has helped complete 76 trials and worked with industry leaders within medtech, biopharma, retail health and healthcare systems. For more information: https://hawthorne-effect.com/