SOUTH SAN FRANCISCO, Calif., Oct. 27, 2021 /PRNewswire/ -- Freenome, a privately held biotech company, together with researchers from Morehouse School of Medicine, presented research earlier this week at the American College of Gastroenterology (ACG) annual meeting that demonstrates rates of enrollment in a colorectal cancer screening study of African Americans (AAs) from an HBCU is similar to Caucasian enrollment at other sites.
PREEMPT CRC, Freenome's multi-center clinical study on colorectal cancer, is in the final stages of enrollment. The study leverages a novel hybrid model that includes both virtual and traditional recruitment to reach underserved communities and ensure a diverse and representative population. With an estimated enrollment of more than 25,000 individuals, PREEMPT CRC represents the largest registrational study to date for a CRC screening test for asymptomatic, average risk adults in the United States.
The research examined enrollment rates at the HBCU compared to a subset of other PREEMPT CRC study sites for which similar pre-screening data were available (26 of the 180 total sites). Sociodemographic data, including income, marital status and insurance status were similar across all sites. The main difference was race. At the HBCU, participants were 80.0% AA and 9.0% Caucasian, while at other sites, the participants were 11.5% AA and 82.8% Caucasian.
Researchers found the enrollment rate among those meeting eligibility criteria was 55.0% at the HBCU compared to 49.8% at other study sites.
The history of abuse in the name of research has created real and well-founded fear and skepticism among African Americans. Clinical trials often have low enrollment of African Americans due to this mistrust, in addition to communication issues with providers, socioeconomic factors and an overall lack of access to clinical trials.
Researchers at Morehouse School of Medicine maximized study recruitment by enlisting racially congruent recruitment staff, synchronizing timing of consent and study procedures, and recording detailed information for all participants.
"It's so important to have a representative, diverse population in clinical trials, and this study shows it's possible," said Julia Liu, M.D., Morehouse School of Medicine and PREEMPT CRC clinical investigator. "Working closely with Freenome, we're able to demonstrate successful enrollment, hopefully setting standards for other clinical trials and their enrollment within African American communities."
"Ensuring diversity in our clinical trials and equitable access in the real world is critical to saving as many lives as possible with our CRC screening test," said Mike Nolan, chief executive officer, Freenome. "We are taking steps now to make sure that our test will be covered and available to everyone."
Freenome is a biotechnology company with the most comprehensive multiomics platform for early cancer detection using a routine blood draw. The company combines its deep expertise in molecular biology with advanced computational biology and machine learning to detect disease-associated patterns among billions of circulating cell-free biomarkers. Freenome is headquartered in South San Francisco, California.
About Morehouse School of Medicine
Founded in 1975, Morehouse School of Medicine (MSM) is among the nation's leading educators of primary care physicians, biomedical scientists, and public health professionals. An independent and private historically-Black medical school, MSM was recognized by the Annals of Internal Medicine as the nation's number one medical school in fulfilling a social mission—the creation and advancement of health equity. MSM faculty and alumni are noted for excellence in teaching, research, and public policy, as well as exceptional patient care. MSM is accredited by the Commission on Colleges of the Southern Association of Colleges and Schools to award doctoral and master's degrees. To learn more about programs and donate today, please visit www.msm.edu or call 404-752-1500.
 Why African Americans may not be participating in clinical trials. Y. Harris, P. B. Gorelick, P. Samuels, I. Bempong; J Natl Med Assoc. 1996 Oct; 88(10): 630–634.
SOURCE Freenome Holdings, Inc.