Advancing Health Equity with Clinical Trial Diversity: Key Strategies

May 02, 2023 - Clinical trials are currently the gold standard for proving the efficacy and safety of new treatments for regulatory approval. Globally, clinical trial data supports medical decisions and drug development. Each year, hundreds of thousands of clinical trials are registered with ClinicalTrials.gov.  Unfortunately, not all clinical trials are created equal, as many fail to recruit or analyze a drug’s efficacy in a diverse patient population. Despite a lack of diversity, a broad range of clinical trial participants is a key strategy for advancing health equity.

Fundamentals of Health Equity

Across the United States, systems of oppression have perpetuated inequities in nearly all spaces. Healthcare is not immune to these impacts, as demonstrated by the persistent gaps in health equity across the US healthcare system.

According to a Kaiser Family Foundation (KFF) article, racism and discrimination are the most discussed components of health inequity; however, economic stability, location, education, food, community, social status, and other elements of the healthcare system may contribute to equity gaps.

The Agency for Healthcare Research and Quality emphasizes four key healthcare areas where inequity persists: maternal health, child and adolescent mental health, substance use disorders, and oral health. Across these categories, there are consistent gaps in care, leading to disproportionately worse patient outcomes in marginalized communities.

Clinical Research

While some inequities are perpetuated by discrimination and prejudice from healthcare professionals through direct patient contact, investigations have revealed that underrepresented patient populations in research have also impacted health outcomes.

Clinical research is the primary tool for regulating drugs, treatments, and medical products globally. With multiple phases and components, clinical trials must recruit participants to test a particular drug’s efficacy and safety profile. Ideally, a clinical trial would recruit a participant population that reflects the diverse population impacted by the disease.

A participant’s genetics or background may impact an intervention’s pharmacokinetics, efficacy, and safety profile. Beyond the physical interactions of the drug, a participant’s financial situation or lifestyle could alter their ability to adhere to specific treatment plans.

Having a varying group of clinical trial participants is critical for ensuring a robust understanding of the drug or treatment’s efficacy for all users and minimizing persistent health disparities.

Providers may look to clinical research to understand how different options compare based on the patient’s background and lifestyle when making therapeutic decisions. Detailed and diverse participant demographics can provide more information for clinicians hoping to personalize a patient’s treatment plan to their needs.

Clinical Trial Diversity

Unfortunately, clinical trial diversity globally — especially in the US — is sorely lacking. An article published in Nature Reviews revealed that 76% of clinical trial participants in 2020 were White worldwide. Meanwhile, only 11% were Asian, and 7% were Black.

Ethnic minority populations, including Black, Hispanic/Latino, Asian, American Indian, and mixed-ethnicity patients, accounted for less than 30% of clinical trial enrollment,

A Phesi analysis published in 2022 noted that 40% of US cancer clinical trials did not have a single Black patient, despite Black Patients having the lowest cancer survival rates.

Beyond a lack of diversity, there is also a lack of transparency regarding participant demographics. A cohort study published in the Lancet Regional Health noted that less than half, 43%, of clinical trials provided any data on race or ethnic group. Additionally, the probability of missing demographic data increased 58% for trials funded by industry or academic centers.

“Diversity and inclusion in clinical trials are essential. As we develop new therapies, we have to set a goal that the patients evaluated in clinical trials are those most burdened by the disease,” said Jennifer Jones-McMeans, PhD, divisional vice president of global clinical affairs at Abbott, in an interview with PharmaNewsIntelligence.

Real-World Impacts

The impact of clinical trial diversity — or lack thereof — goes beyond theoretical conversations regarding health equity. Studies published in 2022 identified multiple instances where a lack of diversity in participant populations resulted in adverse patient outcomes.

In July 2022, an article published in JAMA Internal Medicine identified racial differences in pulse oximeter readings and performance. The researchers noted that although Black patients had a lower median blood hemoglobin saturation, their pulse oximetry readings were 1% higher than White patients.

During the COVID-19 pandemic, pulse oximeter readings were used to determine patients' status and rank their need for more extensive treatment, including supplemental oxygen. Researchers theorize that this contributed to worse COVID-19 outcomes for Black patients.

Many believe the reading discrepancies could have been prevented if medical device developers and manufacturers conducted research studies with more diverse groups.

Just months later, a research letter published in JAMA Network Open identified a similar issue in temporal thermometers. Both instances provide insight into the real-world impacts of clinical trial diversity and its impact on minority health.

“When I go to the physician as an African-American woman, and I’m being treated for a specific disease, it would be good to know whether or not my population was included in the trial evaluation of the therapy,” McMeans stated. “If we don’t set diversity goals, we end up in situations where data shows us that patients of color still make up a tiny proportion of clinical trials for new therapies.”

Clinical Trial Strategies to Advance Health Equity

Researchers have identified a few challenges in clinical trial diversity that must be addressed to promote inclusivity in healthcare and advance health equity. One of the biggest challenges is access to clinical trials.

Unfortunately, clinical trial access can be hindered by location and expenses. People living far away from research centers must make the time and pay for travel expenses. Meanwhile, they are away from the comfort of their home.

One proposed tool for addressing access issues is decentralized clinical trial initiatives. This model, increasing in popularity, allows patients to get treated close to home, cutting down on travel and monitoring expenses. A decentralized clinical trial may include community sites or remote patient monitoring tools depending on the target illness and therapy.

Using these remote strategies removes barriers for patients and improves community engagement, research participation, and participant retention.

Beyond access, provider bias and mistrust may also be significant access barriers. Historical mistreatment of marginalized communities and institutional or personal bias from providers have fueled the research gaps.

With that in mind, clinical researchers must develop partnerships with community leaders and recruit a diverse workforce to foster trust in all communities.

“Clinical researchers must ensure that patients get access, and we do that in part with the investigators we include in a trial. If we do not include investigators who are personally a part of these communities and are reflected in these communities, then access is minimal,” McMeans explained.

For example, McMeans noted that when Abbott launched a clinical trial to evaluate its Esprit BTK Everolimus Eluting Resorbable Scaffold System, which treats blocked arteries below the knees, or critical limb ischemia (CLI), in individuals with advanced stages of peripheral artery disease (PAD), they recruited a diverse board of physicians, including Lyssa Ochoa, MD, board-certified vascular surgeon and founder of the San Antonio Vascular and Endovascular Clinic (SAVE Clinic).

Beyond fostering trust and providing access, education is critical to motivating diverse clinical trial participation. It is up to researchers to ensure the patients have access to all the accurate information on the trial or condition. Educational outreach can be achieved in many ways, including provider education, community events, and social media campaigns.

Abbott created a single source website that patients use to find information about procedures, available treatments, and specific clinical trials.

“The website goes into the disparities in clinical trials, why clinical trials are so important, and why people of color should be participating in clinical trials. It is very accessible to patients and their families,” McMeans highlighted. “We can give patients access, but if they don’t feel confident, or their family members don’t feel competent in the information that they’re getting, that’s going to be that’s going to be a barrier as well.”

Clinical trial diversity is a critical component of public health. Whether researchers submit a new drug to the FDA or providers use data for medical decision-making, data collection from a participant population that reflects the entire patient population is critical.

“It becomes troublesome if we’re just blindly developing therapies and not considering the whole, so we need to do the work to ensure our trials consider all patients. It won’t change overnight, but the awareness is helping shift this healthcare ecosystem as we know it,” she said.

“Clinical trial diversity is vital to create an equitable healthcare ecosystem,” McMeans concluded. “We already know populations are inordinately burdened with societal pressures due to race, economics, poor education, food access, lack of safety, and good health access. As we create new therapies, patients of these diverse backgrounds must be considered.”