By Inez Ruiz-White, Ph.D., Otsuka Pharmaceutical Development & Commercialization, Inc.
Between 2000 and 2020, nearly 80 percent of clinical trial participants were white.1 Additionally, approximately one in five new drugs had differences in exposure or response across racial or ethnic groups, or both.2 To fully understand the safety and efficacy of therapeutic products, the goal should be to explore them in a population representative of the population to receive the therapy in the real world, including diverse racial and ethnic participants.
Underrepresentation of diverse racial and ethnic groups is not a new issue, nor is it limited to clinical trials. For example, a new report from the Satcher Health Leadership Institute at Morehouse School of Medicine (SHLI) provides tangible evidence demonstrating how decades of systemic mental health inequities have yielded significantly worse outcomes for racial and ethnic minorities and marginalized and under-resourced populations. The report, supported by Otsuka America Pharmaceutical, Inc. (Otsuka), showed that nearly 6 million Americans are not accounted for in national reporting estimates regarding mental healthcare. This deficit has crippling implications on policies, funding, access to care, and resources.
To address disparities that have long existed across the healthcare spectrum, there must be an innate understanding of the cultural barriers that persist and the opportunities that will help overcome them. As our industry works toward identifying the best path forward, five guiding principles have the potential to create lasting effects regarding expanding racial and ethnic diversity in clinical trials.
1. Understand The Importance Of Cultural Competency
The cultural competency and diversity of clinical investigators is an important consideration when examining the reasons for low participation in clinical trials among minority populations. For example, language barriers may prevent patients from learning about, understanding, and participating in clinical trials. This is especially true for those who have increased difficulty with health literacy, such as older adults, immigrants, minorities, and individuals with low incomes.
Relatability is also important. One study found that the majority of non-Hispanic Black adults thought it was either very important (31.7%) or somewhat or slightly important (29.4%) to have a healthcare provider who shared or understood their culture.3 This should be top of mind when thinking about the reasons for the current lack of diversity among individuals who participate in clinical trials.
Knowing that cultural differences may affect a person’s health decisions, training individuals on cultural differences and to understand cultural aspects of health and illness can prove invaluable.
Otsuka participated in a global survey study with Tufts Center for Study of Drug Development to study staff diversity of investigative sites. The findings showed that worldwide, regardless of geographic location, the diversity of patients enrolled in clinical trials is highly correlated with site personnel diversity.4 In addition, non-white staff reported lower exposure to clinical trials compared to white staff and white staff are recruited for clinical trials at a higher rate compared to non-white staff.5
2. Cultivate Trust Through Transparency
For underrepresented groups, a lack of comfort and trust with the clinical trial process remains a challenge. The Tuskegee Study is a widely recognized and often cited contributor for the mistrust with the Black community; however, unethical medical research has been longstanding within minority groups and is the principal contributor for current mistrust.6,7
It is important to clearly communicate possible risks. Participation in a clinical trial usually involves taking a drug whose efficacy and safety profile is still unknown. The treatment may not work, could cause serious side effects, or could be a placebo. Providing clear information and ample opportunities for individuals to ask questions may help alleviate uneasiness and enable those considering participation to feel more empowered throughout the process. Providing background on the extensive research and testing done previously is also important.
The health and safety of all participants is the number one priority in every clinical trial, and that guiding principle must be made clear every step along the way.
3. Be Inclusive Of Varying Languages And Literacy Levels
According to research from the U.S. Department of Education, only 12 percent of English-speaking adults in the United States have proficient health literacy skills.8 Another study found that participants who self-identify race as African American/Black, self-identify ethnicity as Hispanic, or who have lower income levels or lower education levels were all associated with decreased clinical trial awareness.9
To accommodate all health literacy levels, all materials should be written at a level that can be understood by the vast majority of participants. In addition, it is critical to have translators and bilingual staff at every step of the way throughout the clinical trial journey.
4. Meet People Where They Are
Beyond asking primary care physicians or personnel within other common routes of referral to educate individuals about clinical trials, identifying local opportunities to educate can be beneficial. Places of worship, local colleges, and community centers provide a chance for ongoing authentic grassroots engagement. This not only helps build awareness but also trusting relationships between individuals considering participation and clinical trial recruitment teams.
For example, this past July, Equitable Breakthroughs in Medicine Development, a cross-collaborative, community-based effort, was announced to increase diversity in clinical trials and address systemic barriers to participation by communities of color. The initiative is focused on supporting local sites and patients in underrepresented communities to enhance clinical trial diversity in a sustainable way.
Another example is the Center for Information and Study on Clinical Research Participation’s (CISCRP) Aware for All program, which aims to educate and empower the public in making informed decisions about clinical research participation. This program has been hosted in 60 communities since 2003, with its outreach channels touching 2 to 4 million people so far, and approximately 60 percent of program attendees coming from underserved and minority communities.10 This grassroots community effort creates opportunities to bring information and education to where the people are.
Collaboration is undoubtedly critical in the effort to recruit more diverse racial and ethnic participants in clinical trials. When recruitment is approached from a holistic cultural lens, the potential for lasting impacts is much greater.
5. Strive To Be As Patient-centric As Possible
Patients are people first and healthcare must be delivered as human care. Meeting people where they are is critical and that means understanding that every person’s journey is unique.
Before joining a clinical trial, during informed consent, the research team describes the study to potential participants, including possible side effects and risks. It’s also another opportunity for open dialogue around factors that could hinder their decision to participate – such as time constraints, financial burdens, and transportation.
While all costs are usually covered for participation, and some trials provide financial compensation, any costs are spelled out in the informed consent before every trial. Offering travel and childcare services, as well as flexible hours for appointments – outside of regular business hours – may help alleviate some factors hindering participation.
Consider adopting advanced digital solutions to make technology more accessible to patients, generate better evidence to inform treatment plans, ensure patient safety and data integrity, and optimize trials to meet the needs of patients wherever they may be in their wellness journeys. Consider decentralized clinical trials, and/or leverage tools such as eConsent, eSource, eScanning clinical supplies, etc., that provide real-time insight to trial activities.
It is critical to explore innovative methods, such as fully remote trials, to increase the number and diversity of study populations by making it easier for a much wider range of participants to enroll and contribute their health data.
- Turner, B. E., Steinberg, J. R., Weeks, B. T., Rodriguez, F., & Cullen, M. R. (2022). Race/ethnicity reporting and representation in US clinical trials: A cohort study. The Lancet Regional Health - Americas, 100252.
- Racial/ethnic differences in drug disposition and response: Review of recently approved drugs - Ramamoorthy - 2015 - Clinical Pharmacology & Therapeutics - Wiley Online Library
- National Health Statistics Reports, Number 130, October 8, 2019 (cdc.gov)
- Impact Report Preview.png (2550×2267) (hubspotusercontent10.net)
- Patient and Public Involvement (PPI) Initiative (arma.ac.uk)
- Health Care Poor Underserved. 2010 August; 21(3): 879–897. doi:10.1353/hpu.0.0323
- Adil E. Shamoo (2022) Unethical medical treatment and research in US territories, Accountability in Research, DOI: 10.1080/08989621.2022.2030720
- National Action Plan to Improve Health Literacy
- Clinical trial awareness: Changes over time and sociodemographic disparities - PMC (nih.gov)
- AWARE for All - Center for Information & Study on Clinical Research Participation (ciscrp.org)
About The Author:
Inez Ruiz-White, Ph.D., is the R&D Lead of Diversity, Equity, and Inclusion at Otsuka Pharmaceutical. Ruiz-White leads efforts to enhance diversity in clinical trials and develop strategies that will cultivate a culture that exemplifies DE&I across all levels of the R&D organization.