CRC-PREVENT: Clinical validation trial to show expedited and diverse recruitment for the non-invasive RNA-FIT test that can detect advanced colorectal neoplasia with high sensitivity

ABSTRACT

Background: Prevailing methods for patient recruitment in large prospective studies can be time consuming, expensive, and introduce selection bias against patients with low health literacy or reduced access to healthcare. Previous clinical trials have reported low recruitment of women, minorities, and individuals who face socioeconomic barriers;a concern which has been exacerbated by the COVID-19 pandemic. Here we describe a novel recruitment strategy that helps to address healthcare disparities. This study will support a pre-market approval application to the FDA for a multi-factor RNA-FIT assay for detection of colorectal neoplasia in average-risk individuals between the ages of 45-75. Methods: A decentralized clinical trial (CRC-PREVENT) was launched through a digital campaign (https//www.colonscreeningstudy.com/;NCT04739722) after the RNA-FIT test system entered design-lock. Online advertisements were published on multiple social media sites and engagement with materials directed patients to an online screener. Participants who completed the screener were considered eligible for enrollment if they met CRC-PREVENT inclusion/ exclusion criteria and were willing to complete all components of the clinical trial, including providing a stool sample prior to an optical colonoscopy. Results: After 3 months of active enrollment, 51,588 individuals have engaged with digital advertisements and completed pre-screener surveys to determine eligibility. In total, 35,280 individuals were deemed eligible based on survey response, and 13,294 eligible individuals also expressed interest in the CRC-PREVENT clinical trial. Of these individuals, 48% were female and 34% were over the age of 60 years old. Regarding race, interested individuals directly represented the intended use population 17% were Black or African American, 2.7% were Asian, and 1.3% were Native Hawaiian, Pacific Islander, American Indian, or Alaskan Native. With respect to ethnicity, 8.4% identified as Hispanic or Latinx. The decentralized approach also permitted access to individuals with socioeconomic healthcare inequities 27% had income under $29,999 and 14% were on Medicaid. Individuals were derived from all 48 continental United States, and of those who reported their residential location, approximately 3% were from rural areas. Conclusions: Use of a decentralized recruitment strategy permitted highly successful enrollment in the face of challenges associated with COVID-19. With respect to race, ethnicity, socioeconomic status, and geography, all metrics represented significantly more diverse populations than observed in traditional clinical studies. Decentralized enrollment mitigated selection bias, and will result in data more reflective of the intended use population.