Fostering diversity and inclusion in the preempt CRC study through strategic site selection and innovative recruitment tools.

Abstract

e23025 Background: Diversity in clinical studies is crucial in aligning the study population with the intended patient demographic. Freenome is developing a blood based test (MyTectCRC) intended to offer a convenient and accessible option for colorectal cancer (CRC) screening. Its clinical validation is supported by the PREEMPT CRC study, a prospective, multi-center observational study. PREEMPT CRC was able to achieve a diverse population representing various ethnic, racial, and geographical backgrounds that reflect the United States population. This analysis evaluates the significance of strategic site selection and use of forward-thinking study tools in achieving a diverse and inclusive study population. Methods: Starting in 2020, PREEMPT CRC enrolled participants aged 45-85 at average CRC risk. Eligible and consenting participants underwent a blood draw and a screening colonoscopy, with the blood sample analyzed by MyTectCRC. To ensure diversity, strategic site selection was employed beyond large academic institutions and hospitals to smaller sites and community hospitals. The study also incorporated a decentralized clinical trial (DCT) model to reach broader geographical areas and used electronic consenting and mobile phlebotomy (MP) services to facilitate enrollment. Results: PREEMPT CRC enrolled 48,995 participants and achieved ethnic/racial diversity comparable to 2020 U.S. Census for Blacks (11.2%, vs 13.6%), Asians (6.8%, vs 6.3%) and Hispanic or Hispanic/Latinx (11.2%, vs 19.1%), Native Hawaiian or Other Pacific Islander (0.3% vs 0.4%). The primary site types were community hospitals and regional clinics, accounting for 45.5% of all sites, followed by health systems (12.0%), research institutes (18.5%), and academic centers/teaching hospitals (16.0%). The community clinics and academic centers enrolled the highest proportion of Black participants within their sites (21.4% and 12.1%, respectively). Research institutions had the highest proportion of Asian (24.8%) and Hispanic/Latinx (18.3%) populations. There was no significant difference observed in male versus female distribution between site types. Within traditional sites, 32% used MP service. DCT enrolled 12,137 participants (24.7% of total) from every state in the U.S., including high representation from rural areas (24.5%). Conclusions: PREEMPT CRC integrated multiple methodologies and tools to enhance diversity and inclusivity. This multimodal approach ensured diversified representation through the participation of sites with harder-to-reach populations, which was reflected in ethnic and racial data, as well as the geographical diversity. PREEMPT CRC study underscores the importance of incorporating early diversity planning into study strategy and using multiple methods to broaden the representation of the patient population. Clinical trial information: NCT04369053 .