One year ago, President Biden reinstated the Cancer Moonshot to reduce the nation’s cancer burden and shed light on inequities in cancer care, calling on both the public and private sectors to help meet this challenge. One area where industry can take initiative is ensuring research and clinical trials capture a diverse patient population. A recent analysis shows how far we still need to go.
Most clinical trials in the U.S. enroll a patient population that is not reflective of our nation’s diversity. For example, in more than 100 clinical trials for preventive measures and treatments, women, Asian, and Black participants were underrepresented. Another recent study showed that Black Americans comprised only 3% of oncology clinical trial participants between 2013-2022.
This is unconscionable and dangerous; clinical trials must reflect the diverse populations who will benefit from treatment. Otherwise, we won’t know whether new treatments and screening tools impact different demographic groups in the same way. Few would argue with this premise, yet the biotech and pharmaceutical industries have failed to meet this objective.
This problem is exacerbated because many diseases studied in these trials disproportionately impact minorities. Black Americans, for example, make up a little over 13% of the population but have a 40% higher chance of dying from colorectal cancer (CRC) than the rest of the population.
In 2019, Guardant Health launched the ECLIPSE clinical trial, a large-scale study to evaluate the performance of Guardant’s Shield blood test to detect early signs of CRC in average-risk adults. Unlike most clinical trials in the U.S., our trial was designed to reflect our country’s diverse population. Despite the barriers presented by COVID-19, ECLIPSE successfully enrolled over 20,000 individuals from 34 states between the ages of 45-84, and achieved 13% enrollment among Black Americans, 15% among Hispanics and 7% among Asian Americans. This is largely in line with U.S. demographics and above average for clinical trial enrollment. So how did we do that?
Achieving Diversity in Clinical Trials: Charting a More Equitable Path for Research
By Dr. AmirAli Talasaz, co-Founder & co-CEO of Guardant Health
Three themes were at the core of Guardant Health’s success:
- Partner with communities to raise awareness
- Address cultural and language barriers
- Overcome resource barriers and meet patients where they are
Partner with communities to raise awareness: First, to better understand the challenges and build awareness of participation in research, sponsors must partner with community and patient advocacy groups. With ECLIPSE, we employed a grassroots strategy, working with community physicians, attending health fairs, and turning to advocacy groups to maintain momentum in trial recruitment and CRC screening.
Address cultural and language barriers: Second, we must prioritize a culturally sensitive approach when developing materials. For ECLIPSE, training materials for study site staff emphasized the importance of diverse enrollment, and clinical trial recruitment materials were collaboratively designed to ensure they resonated with local communities. Translation services were also made available to increase representation among diverse communities that have lower CRC screening rates.
Overcome resource barriers and meet patients where they are: Finally, sponsors must design studies to recruit a racially and geographically representative population. In ECLIPSE, Guardant Health partnered with rideshare companies and leveraged mobile phlebotomy to make the trial accessible. Crucially, the trial included a wide range of study sites, including community hospitals, private practices, endoscopy clinics, and academic medical centers. ECLIPSE was conducted in rural and urban locations and of the 200 sites enrolled, over 90% were based in communities rather than concentrated in academic medical centers.
Strategies like these are required to overcome the access barriers that underserved communities face. Unquestionably, the task doesn’t end with diverse enrollment. Once a new technology like blood-based CRC screening is available, implementation studies are equally important to foster real-world application and equitable access to new evidence-based care.
Guardant Health has established partnerships with research institutions to understand the opportunities and barriers to the adoption of blood-based screening, especially in communities where CRC screening rates are low. A study with the University of Chicago will focus on implementing the blood-based CRC screening test in Federally Qualified Health Centers where patients are traditionally underserved. Another partnership with The Ohio State University will study uptake and adherence in rural Appalachia by sending a phlebotomist to collect blood samples for CRC screening alongside a mobile mammography van.
ECLIPSE was a learning opportunity to increase diverse enrollment and Guardant continues to build upon and expand these strategies in our next screening study already underway.
Achieving diversity in clinical studies is crucial to improving overall health equity, which has rightly been a priority of the Biden Administration and Congress. Yet doing so also requires a commitment by study sponsors to invest in strategies that prioritize diverse enrollment in all clinical trials. While not easy, it’s far from impossible, and all of us share this responsibility.
Dr. AmirAli Talasaz is the co-Founder and co-CEO of Guardant Health Inc., a precision oncology company based in Palo Alto, Calif.
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