Mobile phlebotomists conducted at-home blood draws for patients enrolled in Freenome’s trial. [Photo courtesy of Phleb-Finders]
Convenience was the driver, and the traditional clinical trial model had to evolve when it came to a colorectal cancer screening study. The clinical study had 35,000 patients across the U.S.
Chuanbo Xu, Freenome
Cancer doesn’t discriminate.
It’s the second-leading cause of death in the U.S. Early detection is key in treating — and even preventing — cancers like colorectal cancer (CRC).
Despite recommendations that everyone over 45 be screened for CRC, nearly a third of people don’t get screened. This lack of screening helps make CRC the second-deadliest cancer in the U.S.
For some, taking a few days off work for a colonoscopy is inconvenient. For others, the bowel preparation or stool experience can be uncomfortable or unnerving.
To improve adherence and reduce these kinds of barriers, Freenome is developing a test that’s convenient, less cumbersome and easy to administer with a standard blood draw at any doctor’s office or health clinic. With the goal of ensuring our test reaches everyone, it was critical to conduct a broad, representative study that includes everyone.
How did we reach patients of a wide variety of ages, races, ethnicities and genders? How did we ensure people in small towns and/or those without insurance or access to health clinics could participate? Convenience was the driver, and the traditional clinical trial model had to evolve.
We needed to meet patients where they were. And for many, it was online.
Going virtual
When we designed PREEMPT CRC, our registrational study for a blood-based CRC screening test, it was critical that we make it easy for anyone — in any ZIP code — to participate. This means thinking through all avenues to reach multiple populations.
Virtual offerings were key. We created a dedicated website with helpful information and the ability for patients to register right there on the website. With our physician investigators, we offered electronic consenting to make it more convenient for patients to consent online. For those patients who were not comfortable with or close to a hospital or other brick-and-mortar study site, we set up mobile phlebotomy teams to conduct blood draws at patients’ homes. Phone calls and email communication from the study staff provided patients with additional support and information to navigate the study process.
And it worked. PREEMPT CRC enrolled more than 35,000 people across patient ages, genders, races, ethnicities and insurance status in both rural and urban areas in every state in the continental U.S. PREEMPT CRC is representative of the real world.
Overcoming challenges
Like any major operation with a lot of moving parts, we expected challenges. However, we did not anticipate a global pandemic. PREEMPT CRC launched in May 2020 with the goal to offer convenient options for patients and support traditional study sites. As COVID-19 spread across the country, virtual options became even more important.
To reach Black and Hispanic patients in addition to underserved communities like those in rural communities or those without access to health clinics, it was important to have communication and support on the ground. Working with partners like the Colorectal Cancer Alliance (CCA), Dia de la Mujer Latina, Intercultural Center for Health Research and Wellness, historically black colleges and universities like Morehouse School of Medicine, and retail pharmacies like CVS Health’s Clinical Trial Services provided patients with the culturally competent materials and education needed to drive enrollment.
Plan ahead and think differently for your next clinical trial
If you’re planning a clinical study for any therapeutic area, think outside the traditional model and get in the mindset of patients to offer multiple avenues for education, enrollment and participation.
Virtual recruitment, electronic consent and mobile phlebotomy create options to reach patients outside of urban areas with teaching hospitals. Community partners extend reach, offer trust and credibility to educate patients on the clinical study process and their role. Finally, enlisting culturally competent staff to help tailor communication to specific populations.
Let’s hope diverse clinical studies will become the norm rather than the exception in the coming months. My experience with PREEMPT CRC shows that with some key strategic steps, it’s possible.
Chuanbo Xu [Photo courtesy of Freenome]
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.
