Erica K. Barnell, MD, Ph.D. Chief Science Officer at Geneoscopy. In this interview, she speaks about 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.
Origins:
In large prospective studies, standard patient recruiting procedures can be time-consuming, costly, and introduce selection bias against patients with low health literacy or limited access to healthcare. Women, minorities, and those with low income have been underrepresented in previous clinical trials, a problem that has been compounded by the COVID-19 epidemic. We describe an innovative recruitment technique that aids in the reduction of healthcare inequities in this paper. This research will be used to support an FDA pre-market approval application for a multi-factor RNA-FIT assay for the identification of colorectal neoplasia in average-risk people aged 45 to 75.
Methodologies:
After the RNA-FIT test system entered design-lock, a decentralized clinical trial (CRC-PREVENT) was launched via a digital campaign (https://www.colonscreeningstudy.com/; NCT04739722). Patients were routed to an online screener after engaging with materials that were posted on numerous social media sites. Participants were considered eligible for participation if they met the CRC-PREVENT inclusion/exclusion criteria and were willing to participate in all aspects of the clinical trial, including giving a stool sample prior to an optical colonoscopy.
Findings:
51,588 people have engaged with digital marketing and completed pre-screener surveys to determine eligibility after three months of active enrollment. A total of 35,280 people were deemed eligible based on survey responses, and 13,294 of them indicated an interest in participating in the CRC-PREVENT clinical trial. Females made up 48 percent of those surveyed, and 34 percent were above the age of 60. In terms of race, interested people were 17 percent Black or African American, 2.7 percent Asian, and 1.3 percent Native Hawaiian, Pacific Islander, American Indian, or Alaskan Native. When it came to ethnicity, 8.4 percent said they were Hispanic or Latinx. Individuals with socioeconomic healthcare disparities were also able to benefit from the decentralized approach: 27% had income under $29,999 and 14% were on Medicaid. Individuals were drawn from all 48 states in the continental United States, with about 3% of those who specified their residential place hailing from rural areas.
Outcomes:
Despite the constraints of COVID-19, the use of a decentralized recruitment technique allowed for a high rate of enrollment. All measures reflected substantially more diverse groups than those seen in typical clinical trials in terms of race, ethnicity, socioeconomic position, and geography. Decentralized enrollment reduced selection bias, resulting in data that is more representative of the intended audience. NCT04739722 is the number for the clinical trial.