D0177 - Utilizing a Decentralized Clinical Study Approach for Expedited and Diverse Recruitment for Clinical Validation of a Novel Non-invasive Multitargeted Stool-based RNA Test

Tuesday, October 25, 2022

10:00 AM – 12:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

Haytham Gareer, MD, PhD, MBA

Geneoscopy, Inc.
St. Louis, MO

Elizabeth Wurtzler, ¹, Erica Barnell, PhD², Andrew Barnell, MBA¹, Yiming Kang, ³, Haytham Gareer, MD, PhD, MBA²
¹Geneoscopy, St. Louis, PA; ²Geneoscopy, Inc., St. Louis, MO; ³Geneoscopy, St. Louis, MO

Introduction: Traditional clinical trials that utilize fixed sites often fail to recruit participants that are representative of the intended use population. Participants, particularly those from minority groups, cite geographical constraints, mistrust, miscommunication, and discrimination as barriers to successful recruitment. A decentralized clinical trial enrollment strategy offers reduced cost, reduced time requirements, and circumvents barriers associated with the recent pandemic outbreak.

Methods: After the mt-sRNA test system entered design-lock, a decentralized clinical trial (CRC-PREVENT) was launched through a digital campaign (https://www.colonscreeningstudy.com/; NCT04739722). 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 eligible for enrollment if they met CRC-PREVENT inclusion and exclusion criteria and were willing to complete all clinical trial components, including providing a stool sample before an optical colonoscopy.

Results: After 12 months of active enrollment, 276,400 individuals engaged with digital advertisements and completed pre-screener surveys to determine eligibility for the clinical trial. In total, 14,264 individuals consented to participate in the CRC-PREVENT clinical trial. Of these individuals, 58% were female (42% were male), and 65% were over 50. Regarding race and ethnicity, eligible individuals directly represented the intended use population: 16% were Black or African American, 0.2% were Native Hawaiian, Pacific Islander, American Indian, or Alaskan Native, and 7% were Hispanic or Latinx. Regarding socioeconomic status, the decentralized approach permitted access to individuals with healthcare inequities: 25% of participants had income under $29,999, 5% of participants were from rural areas (defined as a city center < 10,000 people), and 36.7% of participants were on public insurance. Individuals were derived from 7,644 unique zip codes across all 48 continental United States.

Discussion: A decentralized recruitment strategy permits highly successful enrollment in the face of screening burdens heightened by COVID-19 pandemic. This approach also offered a significantly more diverse population and could mitigate selection bias and attrition bias associated with the cohorts observed in traditional clinical studies.

Age	N	%
< 44	8	0.1%
45-50	4886	34.3%
51-60	5491	38.5%
61-70	3220	22.6%
>70	595	4.2%
Total	14200

Gender	N	%
Female	8259	57.9%
Male	5939	41.6%
Other	27	0.2%
Prefer not to answer	39	0.3%
Total	14264

Race	N	%
American Indian or Alaskan Native	122	0.1%
Asian	458	3.2%
Black or African American	2243	15.8%
Native Hawaiian or Other Pacific Islander	33	0.2%
Other	514	3.6%
Prefer not to answer	96	0.7%
White	10731	75.6%
Total	14197

Ethnicity	N	%
Hispanic or Latino	976	6.9%
Not Hispanic or Latino	12713	89.5%
Prefer not to answer	508	3.6%
Total	14197

Insurance type	N	%
No insurance	162	1.1%
Private insurance	8516	60.0%
Public insurance (Medicaid)	1880	13.2%
Public insurance (Medicare Advantage)	1199	8.4%
Public insurance (Medicare)	2135	15.0%
Self-insured	305	2.1%
Total	14197

Income	N	%
$100,000-$149,999	1958	13.8%
$150,000-$199,999	966	6.8%
$200,000 or more	996	7.0%
$30,000-$49,999	1833	12.9%
$50,000-$74,999	1855	13.1%
$75,000-$99,999	1634	11.5%
Prefer not to answer	1354	9.5%
Under $29,999	3605	25.4%
Total	14201

Table: Enrollment distribution per demographics, insurance type and income

Disclosures:

Elizabeth Wurtzler: Geneoscopy Inc – Employee, Intellectual Property/Patents, Stock Options, Stock-privately held company.

Erica Barnell: Geneoscopy – Advisory Committee/Board Member, Employee, Intellectual Property/Patents, Owner/Ownership Interest, Stock Options, Stock-privately held company.

Andrew Barnell: Geneoscopy – Employee, Owner/Ownership Interest, Stock Options.

Yiming Kang: Geneoscopy, Inc – Employee.

Haytham Gareer: Geneoscopy – Employee, Stock Options.

Elizabeth Wurtzler, ¹, Erica Barnell, PhD², Andrew Barnell, MBA¹, Yiming Kang, ³, Haytham Gareer, MD, PhD, MBA². D0177 - Utilizing a Decentralized Clinical Study Approach for Expedited and Diverse Recruitment for Clinical Validation of a Novel Non-invasive Multitargeted Stool-based RNA Test, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.