How to use technology to stimulate diversity in clinical trials

Mobile phlebotomists performed blood collection at home for patients included in the Freenome trial. [Photo courtesy of Phleb-Finders]

This colorectal cancer screening study included 35,000 patients in the continental United States

Chuanbo Xu, Freenome

Cancer does not discriminate.

This is the second leading cause of death in the United States. Early detection is key to the treatment and even prevention of cancers such as colorectal cancer (CRC).

Despite the recommendation that everyone over the age of 45 be screened for CRC, nearly a third of people are not screened. This lack of screening is helping to make CRC the second deadliest cancer in the United States

For some, taking a few days off for a colonoscopy is inconvenient. For others, bowel or stool preparation can be uncomfortable or irritating.

To improve adherence and reduce these types of barriers, Freenome is developing a test that is convenient, less cumbersome, and easy to administer with standard blood sampling at any doctor’s office or health clinic. In order to ensure that our test reaches everyone, it was crucial to conduct a broad, representative study that included everyone.

How did we reach patients of a wide variety of ages, races, ethnicities and genders? How did we ensure that people in small towns and / or those without insurance or access to health clinics could participate? Convenience was the engine, and the traditional clinical trial model had to evolve.

We had to meet the patients where they were. And for many, it was online.

Transition to virtuality

When designing the PREEMPT CRC, our blood-based CRC screening test registration was crucial to make everyone’s participation easier – with any zip code. This means considering all avenues to reach multiple populations.

Virtual offers were key. We have created a special website with useful information and the opportunity for patients to register right there on the website. With our research doctors, we proposed electronic consent to make it more convenient for patients to give consent online. For those patients who did not feel comfortable in a hospital or near a hospital or other study site, we set up mobile phlebotomy teams to perform blood collection at patients’ homes. Phone calls and email communication from the study team provided patients with additional support and navigation information during the study.

And it happened. PREEMPT CRC has enrolled more than 35,000 people of all ages, genders, races, ethnicities, and insurance status in both rural and urban areas in each state in the continental United States. PREEMPT CRC is representative of the real world.

Overcoming challenges

Like any major operation with many moving parts, we expected challenges. However, we did not expect a global pandemic. PREEMPT CRC was launched in May 2020 with the aim of offering user-friendly options and maintaining traditional research sites. With the spread of COVID-19 across the country, virtual options have become even more important.

In order to reach black and Hispanic patients in addition to underserved communities such as those in rural communities or those without access to health clinics, it was important to have communication and support in place. Working with partners such as the Colorectal Cancer Alliance (CCA), Dia de la Mujer Latina, the Intercultural Center for Health Research and Wellness, historic black colleges and universities such as the Morehouse School of Medicine and retail pharmacies such as CVS Health’s Clinical Trial Services provides patients with culturally competent materials and education needed to stimulate enrollment.

Plan ahead and think differently about your next clinical trial

If you are planning a clinical trial for any therapeutic area, think outside the traditional model and enter into the thinking of patients to offer many opportunities for education, enrollment and participation.

Virtual recruitment, e-consent and mobile phlebotomy create opportunities to reach out-of-town patients with training hospitals. Community partners expand, offer trust and credibility to educate patients about the clinical trial process and their role. Finally, attracting culturally competent staff to help adapt communication to specific groups of the population.

Hopefully, a variety of clinical trials will become the norm, not the exception, in the coming months. My experience with PREEMPT CRC shows that with some key strategic steps it is possible.

Portrait of Chuanbo Xu, Senior Director of Clinical Development at Freenome

Chuanbo Xu [Photo courtesy of Freenome]

Chuanbo Xu is Senior Director of Clinical Development at Freenome. With 20 years of clinical experience, he leads teams in various disciplines in the development of products that meet unmet medical needs.

The views expressed in this blog post are those of the author only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

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