Freenome, a privately held biotech company, together with the Morehouse School of Medicine, presented findings at the Digestive Disease Week (DDW) annual meeting showing high clinical study enrollment of Black patients using various strategies to reduce participation barriers. The poster addresses underrepresentation of Black people in clinical studies and was recognized with a Poster of Distinction Award.
This research was initiated in 2021 as part of PREEMPT CRC, a study to validate a blood test to detect colorectal cancer (CRC) and advanced adenomas. Freenome and Morehouse researchers examined the enrollment rate of Black patients at Morehouse School of Medicine, a Historically Black College or University (HBCU) and study site, compared to White patients at 168 other study sites over a 7-month evaluation period.
The HBCU site ranked in the top 11th percentile for patient enrollment across all study sites.
Researchers found that by implementing various strategies, the enrollment rate among Black participants at Morehouse was quite high, compared to other study sites. The HBCU site enlisted racially congruent recruitment staff, synchronized timing of consent and study procedures, and recorded detailed information for all patients.
PREEMPT CRC is Freenome’s large registrational study for CRC screening using a standard blood draw. The study closed enrollment earlier this month and includes more than 35,000 participants across racial, ethnic and socioeconomic groups from every state in the continental United States. While African American and Hispanic populations typically represent only 5% and 1% of clinical trial participants, respectively,1 early data from PREEMPT CRC indicates that the study includes approximately 11.3% Blacks and 10.3% Hispanics.
“Black patients are typically underrepresented in clinical trials for a variety of reasons, one big reason being a lack of access to trials,” said Julia Liu, M.D., Morehouse School of Medicine and PREEMPT CRC clinical investigator. “These findings demonstrate that, with the right steps, Black patients will participate in clinical studies at the same if not higher rate than White patients.”
“Our screening tests are for everyone—and part of that is ensuring that our clinical studies include everyone,” said Lance Baldo, M.D., chief medical officer at Freenome. “Health equity and a strong commitment to all patients is essential to the future of healthcare.”