The need to include underrepresented groups in clinical trials isn’t new. The medical community is well aware that racial and ethnic minorities, women, and people who don’t identify as cisgender get frequently excluded, leading to data that skews towards white and male. Unfortunately for trial sponsors, the data collected in these trials aren’t always generalizable.
Trial participation that includes racial and ethnic minorities will allow researchers to find equitable solutions to diseases—like cancer, diabetes, and heart disease—that create disproportionate burdens in communities of color. Read more about the importance of equity in clinical research.
Despite representing 13.5% and 18.1% of the United States population, African Americans and Hispanic/Latinos make up only 5% and less than 1% of clinical trial participants, respectively. In oncology trials, in particular, these numbers aren’t much better: a recent study published in an American Society of Clinical Oncology (ASCO) Educational Book found that in a cohort of 5,157 clinical trial participants, only 38% were women, 15% were Asian American, 4% were Hispanic or Latino, and 4% were Black or African American. Nearly 70% of participants, though, were White or of European descent.
Different Races, Different Health Concerns
For clinical research to be truly inclusive, sponsors and research teams must make concerted efforts to include racial and ethnic minorities in study populations. Initiatives at the federal level, via the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Center for Medicare and Medicaid Services (CMS), have led to minor, nonsignificant improvements in minority inclusion in clinical research.
People are people, but some races and ethnicities are more likely to experience certain health conditions than others; for example, African Americans are twice as likely to die from heart disease than White Americans and are 50% more likely to have high blood pressure. Hispanic or Latino are more likely to be affected by obesity, diabetes, asthma, and chronic obstructive liver disease. Additionally some ethnic groups may respond better to certain therapies, while others see no benefit. Without studying the effects of new treatments in a representative population, we introduce risk into the both the clinical development lifecycle—and also into the market once new treatments are approved.Read our experts’ insights about diversity in clinical trials.
Barriers to Minority Participation
Luckily for clinical researchers, numerous barriers to minority participation in clinical trials have been identified. For racial imbalances, one 2019 study identified mistrust, a lack of comfort with the clinical trial process, a lack of information about clinical trials, constraints on time and resources, and a lack of awareness of specific clinical trials as barriers. Low income, investigator bias, and limited health and research literacy have also been identified as barriers to participation.
Previous presumptions that were made about clinical research are resurfacing today when it comes to the COVID-19 vaccine. Hesitancy is often confused with refusal, and many of these same barriers limit access to the vaccine in Black communities, which are not being sufficiently addressed.
Scott Schliebner, Senior Vice President of Therapeutic Expertise, and Head, Center for Rare Diseases says that “We need to tackle any barriers head-on. Whether it’s creating awareness, reducing patient burden, building trust, educating patients, getting research into patient community care, or using technology to minimize geographic barriers, we need to be compassionate to what the patients’ challenges are and find ways to meet them where they are. Wherever that may be.”
The Association of Clinical Research Professionals identified three specific strategies to promote diversity among trial participants. The first—and perhaps most important—goal is addressing potential mistrust by participants. African Americans, in particular, have documented reasons to distrust the medical system: the Tuskegee Syphilis Study is a landmark in unethical research, and no concrete consensus exists on how negatively the study has affected African American research participation in the long-term. The general history of exploitation of African Americans in the United States has also sown distrust, with one interview study indicating that African American participants had significant concerns regarding physician honesty in terms of the study risks and the full details of what research participation would require.
Physician bias may also play into these concerns, elevating false perceptions and prejudices above the necessity of equity in medical research. The results of a study published in Social Science & Medicine found that some physicians—and therefore, some researchers—may have biases about which patients will comply with difficult therapeutic regimens based on race.
The research community must also address both financial and physical access to clinical trials. Low-income participants—who may also be facing extrinsic factors that impact health outcomes—may be more willing to participate if sponsors address upfront the potential for compensation and how healthcare needs and potential insurance issues will be addressed after the trial concludes. By considering how competing demands, like childcare and inflexible work schedules, might impact participant availability, sponsors can create programs that offer childcare services or transportation to and from the study site to mitigate those issues.
Culturally competent communication strategies also stand to increase minority recruitment and participation. Cultural competence is critically important when trying to reach minority groups; using these strategies to engage communities and reach potential participants—individuals who may mistrust or misunderstand the clinical research process—can increase interest and, ultimately, enrollment. Importantly, these strategies also allow research teams to reach communities where they are, rather than assuming what type of communication and content will work. Such initiatives may also reduce, eliminate, or reframe unconscious biases on the part of the research team.
Outcomes of Diversity
Achieving racial equity in clinical trial research would represent a significant shift not only in the medical community but in society at large. Trial participation that includes racial and ethnic minorities will allow researchers to find equitable solutions to diseases—like cancer, diabetes, and heart disease—that create disproportionate burdens in communities of color. Reducing or eliminating these burdens will allow these communities to thrive.
In November 2020, the FDA released industry guidance for increasing diversity among clinical trial participants. Broadening eligibility criteria, adopting inclusive enrollment practices, and rethinking the methodological approach to include a broader patient population are just a few of the many suggestions the FDA put forth in the hopes of bringing more representative research to the table. Studies that prioritize diverse research will also, they add, contribute to the discovery of important safety information and individual drug risk-benefit profiles within the particular populations who will be using the drug after approval.
Evidence-based research powers the healthcare industry for good reason: evidence-based practice leads to the best outcomes for the highest number of patients. So much of this evidence stems from clinical research studies on interventions, drugs, and medical devices; prioritizing equitable inclusion of races, genders, and ethnicities on the clinical trial level is one of the best ways to ensure that diversity is present at all levels of care.
PRA’s Francisca Burtenshaw, FCIPD, FRSA, Senior Director of Human Resources (HR) says, “HR professionals are adopting more innovative approaches, thinking out of the box and being creative on how we can address such so big issues like equality, diversity, and inclusion with Talent Acquisition and Retention strategies that can support the entry, development, and career progression of women and ethnic minorities.” Because it’s so difficult to change the world with short-term solutions, Francisca believes it’s best to “look outward and learn from best practice with an innovative and long-term approach, investing in continuous education and in future generations so they can become agents of change as the future of work seems to be quite different right now.”
The current drug development research paradigm is flawed in that it fails to include a diverse and representative patient population. A new approach that begins with a patient-centric mindset, coupled with the use of mobile technology and connected health platforms, will enable research to become less reliant on site-based visits and bring equal access to new investigational therapies for all patients, regardless of geography, ethnicity, sex, or gender.
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