How to leverage technology to drive diversity in clinical research

Mobile phlebotomists performed home blood draws for patients who signed up for the Freenome test. [Photo courtesy of Phleb-Finders]

This color-screen cancer screening study enrolled 35,000 patients in the continental United States

Chuanbo Xu, Freenome

Cancer does not discriminate.

It is the leading cause of death in the United States. Early detection is key to treating and even preventing cancers such as colon cancer (CRC).

Despite the recommendations for CRC testing for all over the age of 45, almost a third of people do not take the test. This non-screening is helping to make CRC the second deadliest cancer in the United States

For some, taking a colonoscopy is uncomfortable. For others, the intestinal preparation or stool experience may be uncomfortable or worrisome.

To improve adherence and reduce barriers of this type, the Freenome test is being developed in any medical office or health clinic with a standard blood test that is convenient, so heavy, and easy to administer. In order to ensure that our test is accessible to all, it was essential to conduct a comprehensive and comprehensive study that included all of them.

How did we reach patients of all 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? Comfort was the driver and the traditional model of clinical trials had to evolve.

We needed to know where the patients were. And for many it was online.

Virtual touring

When we designed PREEMPT CRC, our blood-based CRC screening test record analysis, it was essential to make it easier for anyone — in any ZIP code — to participate. This means thinking in all ways to reach diverse populations.

Virtual offerings were key. We have created a dedicated website with helpful information and the opportunity for patients to register on the website. With our medical researchers, we offered electronic consent to make it more convenient for patients to consent online. For patients with or without a hospital or other brick test site, we created mobile phlebotomy groups to perform blood draws in patients ’homes. Examination telephone calls and e-mail communications provided support and additional information to patients to navigate the examination process.

And it worked. The PREEMPT CRC enrolled more than 35,000 people in the age, gender, race, ethnicity, and insurance status of patients in both rural and urban areas across the continental United States. PREEMPT CRC is a real-world representative.

Overcoming challenges

As with any major operation involving many moving parts, we expected challenges. However, we did not anticipate a global pandemic. PREEMPT CRC was launched in May 2020 with the aim of providing patients with convenient opportunities and support for regular examination sites. As COVID-19 spread across the country, virtual opportunities became even more important.

In order to reach out to black and Hispanic patients, rural communities, or low-income communities that do not have access to health clinics, it was important to have communication and support on the ground. Patients were offered the opportunity to work with retail pharmacies such as the Colorectal Cancer Alliance (CCA), Latin Women’s Day, Intercultural Center for Health Research and Welfare, historic black universities and universities such as Morehouse Medical School, and CVS Health’s Clinical Trial Services. culturally competent materials and education to encourage enrollment.

Plan ahead and think differently for your next clinical trial

If you are planning a clinical trial for any therapeutic area, think outside the traditional model and incorporate patient education into your mindset to provide a variety of avenues for education, enrollment, and participation.

Virtual procurement, electronic consent, and mobile phlebotomy create opportunities for outpatient access to teaching hospitals. Community partners broaden their reach, provide confidence and credibility to educate patients in the process of clinical examination and their role. Finally, bring together culturally competent staff to help adapt communication to specific populations.

Hopefully in the coming months several clinical trials will become the norm rather than the exception. My experience with PREEMPT CRC shows that it is possible with a few key strategic steps.

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

Chuanbo Xu [Photo courtesy of Freenome]

Chuanbo is the director of clinical development at Xu Freenome. With 20 years of clinical experience, he has led teams from all disciplines to develop products that meet unmet medical needs.

The opinions expressed in this blog post are solely those of the author and are not necessarily reflected by MedicalDesignandOutsourcing.com or its staff.

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