Social Media And A Site-Less Model Led This Trial To Pandemic-Era Success

A conversation with Geneoscopy Chief Science and Medical Officer Erica Barnell, MD, Ph.D.

For most trials slated in 2020, and even in some later pandemic years, enrollment delays were inevitable. The restriction of in-person activities or, if they were allowed, the imposition of social distancing guidelines, negatively affected patients’ ability to participate in or interest in enrolling in clinical trials.

Yet, Geneoscopy forged ahead with its Phase 3 trial (CRC-PREVENT) for ColoSense, an RNA-based noninvasive screening test for colorectal cancer. Unlike other trials, this one thrived in the era of pandemic restrictions. 

Here, the company’s Chief Science and Medical Officer Erica Barnell, MD, Ph.D. discusses two main tactics that contributed to its success — a complete dependence on social media recruiting and a site-less trial design. 

The study identified nearly 9,000 participants for the Phase 3 trial (CRC-PREVENT) for ColoSense using social media marketing. What led you to include social media in your recruitment efforts?

Our clinical trial launched during the COVID-19 pandemic when many endoscopy sites were closed and unable to participate. This challenge required us to adopt creative recruitment strategies, with social media marketing becoming the cornerstone of our approach. Through these efforts, we reached over 270,000 potential participants, leading to the enrollment of more than 14,000 subjects within 12 months. Ultimately, approximately 9,000 participants completed both the ColoSense test and a colonoscopy, making them eligible for primary endpoint assessment (ColoSense sensitivity and specificity).

What portion of your recruitment efforts was done on social media?

Our entire recruitment process — 100% — was conducted via social media. We did not establish any physical sites for the CRC-PREVENT clinical trial. Participants were recruited from over 5,400 ZIP codes, and colonoscopies were performed at more than 3,800 different endoscopy centers.

Which social media platforms did you use, and why?

We utilized a variety of social media platforms to engage diverse patient populations. Facebook was a leading resource in our recruitment efforts, and we also leveraged Google and several other platforms. Some platforms were selected for their older demographic, helping us reach a population that has a higher incidence of colorectal cancer. Others allowed us to connect with diverse and representative populations, including those from rural areas and individuals facing significant health disparities. Unlike traditional clinical trials, which rely on on-site volume for recruitment, our social media-driven approach enabled participants to complete their ColoSense test and colonoscopy regardless of location. This strategy facilitated high engagement with the subjects we aim to serve commercially as part of our intended use population.

How did you determine the most suitable design and messaging of the social media outreach to target your audience?

We experimented with various approaches to engage potential participants. Some individuals were motivated by a family history of colorectal cancer or advanced adenomas, while others were drawn to the opportunity to get paid for submitting a stool sample. Our most effective advertisements emphasized the importance of screening for gut health while addressing concerns about the process. This included clear guidance on completing stool sample collection and assistance with colonoscopy scheduling. Ultimately, we found that people want to take care of their health, and providing support, reassurance, and personalized engagement played a key role in successfully enrolling and testing participants.

How did you adapt the marketing materials for the different platforms?

Developing marketing materials was a collaborative process to ensure engagement and accuracy while reflecting the clinical trial experience. We worked closely with our medical team, an external CRO and the IRB to ensure compliance across all materials. Each platform required tailored messaging and visuals to resonate with its specific audience while maintaining consistency in trial information and expectations.

The trial incorporated decentralized elements as opposed to all in-person, in-office activities. To decide which elements to conduct remotely, who did you consult — providers, patients, previous successful trials, and their study builders, etc.?

There was no established roadmap for conducting a fully decentralized clinical trial. We were the first company to complete a PMA for a Class III medical device using a 100% decentralized approach, making the process a combination of strategic planning and trial and error. Rather than relying on a single source, we explored multiple approaches and implemented the most effective ones. Flexibility was key — we weren’t afraid to pivot when needed. Along the way, we gained valuable insights that have become integral to Geneoscopy’s operations and the commercial launch of ColoSense. This includes ensuring seamless navigation to colonoscopy for patients with a positive result, reinforcing our commitment to comprehensive patient care.

What decentralized elements were included in the trial design?

The trial incorporated several decentralized elements to streamline recruitment, testing, and data collection. A call center managed all recruitment, education, and scheduling for healthcare interactions. Collection kits were shipped directly to participants from a remote manufacturing facility, and completed kits were sent to a centralized testing site at Geneoscopy for analysis. On the back end, colonoscopy results were sent to a CRO contracted by Geneoscopy, with all records securely maintained in a centralized electronic database.

Which elements did you decide to keep in-person?

The trial did not involve in-person visits. In fact, many physicians performing the colonoscopies were unaware that their patients were enrolled in the clinical trial. This fully decentralized approach contributed to the trial’s success by reducing logistical barriers and significantly lowering the costs associated with setting up traditional testing sites.

Which elements were the easiest to execute, and which were the most challenging?

The easiest elements to execute were those that leveraged existing infrastructure, such as shipping collection kits directly to participants and processing samples at our centralized testing site. These processes were streamlined and required minimal intervention once established. The most challenging aspects involved patient engagement and compliance. Ensuring participants completed their stool sample collection and followed through with their colonoscopy required continuous communication and support. The decentralized nature of the trial also introduced complexities in coordinating with a diverse network of endoscopy centers and integrating data from multiple sources. However, by implementing a dedicated nurse call center and refining our outreach strategies, we overcame these challenges and successfully executed the trial.

How does the decentralized nature of the trial help you understand how patients might use ColoSense in a real-world setting?

We live in a world where convenience and instant gratification are expected — healthcare is no exception. Just as consumers anticipate next-day delivery from online retailers, patients want their screenings to be simple, noninvasive, and hassle-free. They want to come home to find the test kit waiting on their doorstep and have it picked up once completed, without extra effort on their part. By implementing this patient-centric approach during the clinical trial, we gained valuable insights into real-world usage and carried those learnings into the commercial launch of ColoSense. The reality is that traditional healthcare is shifting away from the doctor’s office as the primary point of care. Companies must be ready to adapt and meet patients where they are, ensuring accessibility and ease of use at every step of the process.

What were some lessons learned with this approach?

One of the biggest lessons learned was the importance of adaptability. Conducting a fully decentralized clinical trial required us to continuously refine our processes based on real-time feedback. We learned that clear communication and patient support were essential to maintaining engagement and ensuring compliance, especially when participants managed  test completion and colonoscopy scheduling on their own. Additionally, we saw firsthand how much patients value convenience. By eliminating traditional barriers — such as travel to testing sites or lengthy appointment wait times — we were able to improve accessibility and participation. This reinforced the need for healthcare solutions that fit seamlessly into patients’ lives rather than requiring them to navigate complex systems.

With the decentralized trial design and the social media recruitment efforts, did you assume or even witness some correlations between the two — such that potential participants who spend time socializing online would prefer participating in a trial remotely?

Yes, we observed a strong correlation between social media recruitment and the success of our decentralized trial model, particularly in reaching individuals who might not have engaged with traditional screening methods. Notably, 64% of enrolled subjects had never been screened with any modality (colonoscopy, FIT, or molecular test), and 70% did not have a colonoscopy scheduled at the time of enrollment, requiring navigation to complete the procedure. 

Despite these initial barriers, 80% of participants completed a ColoSense test and, of those, 80% were successfully navigated to colonoscopy as part of the study. In contrast, traditional site-based models typically recruit subjects already engaged with the healthcare system — often individuals who are more health-literate and have an existing colonoscopy appointment. This means conventional trials may not fully capture the population needing accessible alternative screening options. By leveraging social media and a decentralized design, our trial was likely more reflective of the patients we aim to serve — those who might otherwise avoid or delay screening due to inconvenience, lack of awareness, or discomfort with traditional modalities. Ultimately, we hope that ColoSense can be a solution for individuals who would not otherwise receive a colonoscopy, expanding access to lifesaving colorectal cancer screening.

Finally, what were some lessons learned with this trial?

Everything takes more time than expected. It’s crucial to start early, move deliberately, and address challenges as they arise. Even on days when progress feels slow, every step contributes to the bigger picture. From concept to FDA approval, the development of ColoSense took about 10 years. However, each day brought us closer to a decision from the agency. Now, being on the other side with an approved product, it’s incredibly rewarding to finally provide care to eligible patients.

About The Expert:

Geneoscopy co-founder, Dr. Erica Barnell graduated from Cornell University with a dual degree in biological sciences and applied economics & management. She completed her MD-Ph. D. at the Washington University School of Medicine in 2023 and obtained a Ph.D. in molecular genetics and genomics through the McDonnell Genome Institute. Dr. Barnell currently serves as Geneoscopy’s chief medical and science officer. She led clinical and regulatory efforts related to Geneoscopy’s lead product, ColoSense, which was just approved by the FDA for average-risk colorectal cancer screening in subjects 45 and older. Dr. Barnell has published 29 peer-reviewed manuscripts, four patents, and two book chapters within the precision medicine space. Dr. Barnell was named to the Forbes 30 Under 30 list in 2020.