In April, the FDA published draft guidance for sponsors on how to create a “Race and Ethnicity Diversity Plan” that will help to ensure they enroll proportionate numbers of participants from underrepresented racial and ethnic populations in their clinical trials.1 The agency asked for industry feedback on the document by June 13.
The FDA reported that Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and other Pacific Islanders, and other persons of color are often underrepresented in medical research, even in studies of diseases that may be more prevalent among their population. For example, COVID-19 infects Black and Hispanic people at 3.5 times the rate of the general public.
The reasons for this reduced participation are multi-faceted and include lack of access to healthcare, difficulty reaching clinical research sites, and an inherent mistrust of the healthcare system based on historical abuses, such as the USPHS Syphilis Study at Tuskegee, the Diabetes Project with the Havasupai Tribe, and the treatment of Henrietta Lacks.
But it is vitally important that clinical trial populations are truly representative of the general population to make sure that any new products approved by the FDA are safe and effective for everyone who might want to use them. For example, the FDA referenced variations in skin pigmentation, which exist across diverse populations, and can impact the performance of pulse oximeters (which measure oxygen saturation levels in the blood) and some devices that detect skin cancer.
Jumo Health submitted a formal response to the FDA2, applauding the Agency’s comprehensive efforts to improve the enrollment of racial and ethnic populations in clinical trials through study design, education, and continuous process improvement with real world data.
We also fully support the Agency’s efforts to define – indeed redefine – diversity beyond race and ethnicity to include other underrepresented populations defined by:
- gender identity
- socioeconomic status
- pregnancy status
- lactation status
It is critical to ensure that the clinical data collected and analyzed can provide complete and accurate conclusions that represent the entire U.S. population.
In our response, we commended the Agency for underscoring the importance of disease education “for all patients who are expected to use the medical product if approved.” But we also suggested that the FDA consider expanding this goal beyond disease education to ensure that resources are also available for potential clinical trial participants which explain:
- the informed consent/assent forms
- study protocol
- study objectives
- study requirements
These resources should be in a form that is understandable to someone of their age and culture. Providing accessible educational resources is a vital step in enrolling, and most importantly, retaining, participants in a study.
We must overcome the fact that 9 out of 10 adults are health illiterate3,4 and more than 50% cannot read above the 8th grade level.5 The industry is struggling to enroll and retain enough patients; 85% of all clinical trials fail to retain enough patients6 with 93% of all identified patients dropping out after informed consent.
At Jumo Health, we are addressing these challenges head on by developing highly visual, culturally sensitive educational resources in formats that are tailored to match the age and experience of our audience. This approach is imperative to ensure that our audience not only comprehends the information but knows what actions they need to take. We employ a wide range of media, including comic books, animation, virtual reality experiences and documentary-style videos to explain diseases, describe the clinical trial process, and tell patient stories. All our materials are developed by medical doctors, based on evidence-based, published research, and created in partnership with advocacy groups and community organizations.
We have developed education materials for patients and caregivers in more than 100 therapeutic areas, for all the different age groups, and in 92 languages and 76 countries. In fact, we have received institutional review board and ethics committee approval for hundreds of digital and print pieces, describing more than 200 conditions.
We have achieved this level of success by taking a highly inclusive approach, overseen by our internal and external Diversity, Equity, and Inclusion Committees. We collaborate with more than 180 advocacy groups and community organizations globally to ensure that we always represent authentic patient experiences. We also employ Community Engagement Teams, which are local action boards convened to review project materials and provide input on the design, voice and tone used. Those teams later introduce the finished materials to their local communities.
We wholeheartedly support the FDA’s efforts to ensure that sponsors have a Race and Ethnicity Diversity Plan in place from the early stages of their drug, biologic, and medical device development programs. This well considered approach will help to ensure that clinical trial participants are truly reflective of the general population and that medical products which are submitted to the FDA for review will be more safe and effective for all future users.
- FDA Draft Guidance: Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials
- Jumo Health’s response to the draft guidance
- Cutilli CC, Bennett IM. Understanding the health literacy of America: results of the National Assessment of Adult Literacy. Orthop Nurs. 2009 Jan-Feb;28(1):27-32
- Baedorf Kassis, S., S. A. White, L. Myers, C. Trudeau, and B. Bierer. 2019. Advancing health literacy in clinical research: Clear Communications for Every Participant. NAM Perspectives. Commentary, National Academy of Medicine, Washington, DC.
- U.S. DHHS: America’s Health Literacy: Why We Need Accessible Health Information