Ensuring Equal Clinical Trial Access Across Vulnerable Communities

Role of Clinical Trials

The value of clinical trials in healthcare and the pharmaceutical regulatory landscape is unparalleled. Understanding the importance of diversity in clinical trials begins by understanding the role trials play in the healthcare ecosystem.

Clinical trials test the safety and efficacy of treatment options for patients and establish new standards of care. Ultimately, clinical trials drive pharmaceutical innovation and advancements.

The United States Food and Drug Administration’s (FDA) clinical trial diversity fact sheet emphasizes that clinical trial diversity is a significant factor in achieving health equity, as it provides a more comprehensive understanding of a medical product's impact on all socio-demographic groups.

Clinical trial diversity is critical for product success across the intended patient population. Ideally, the pool of trial participants for a particular drug or therapy should be representative of the demographics of the patient population. Studies that only recruit a small subset of patients may be ineffective in a larger pool of individuals.

The National Institute on Minority Health and Health Disparities (NIMHD), part of the National Institutes of Health (NIH), notes that multiple factors can impact disease probability and treatment response, including the following:

• Age
• Biological sex
• Pregnancy status
• Life experiences
• Comorbidities
• Behavioral patterns
• Environmental health
• Genetics
• Location

While this is not an exhaustive list of factors impacting clinical trials, the NIMHD notes that, historically, clinical trials have failed to consider the characteristics of the disease population, recruiting predominantly White male participants regardless of their proportion of the disease population.

For example, an article published in Nature Reviews notes that, in 2020, approximately 76% of clinical trial participants were White. Additionally, data from a 2022 Phesi analysis indicated that about 40% of cancer clinical trials in the US did not include a single black patient, even though they make up the most significant portion of cancer mortality.

According to the NIMDH, “This shortcoming has created gaps in our understanding of diseases and conditions, preventive factors, and treatment effectiveness across populations. These gaps in knowledge can impede the quality of health care decision making, ability to counsel people on ways to reduce their risk, optimal treatment responses, and even the development of more effective medications or interventions.”

Although clinical trial diversity is critical to successful product applications, patient safety, and healthcare outcomes, it remains an issue for researchers and healthcare professionals, with few trials accurately accounting for the vulnerable communities typically excluded.

Improving Clinical Trial Diversity

Although the current landscape is not perfectly diverse, multiple strategies can be implemented to improve clinical trial diversity.

“With a focus on diversity and inclusion in clinical trials combined with our community reach and relationships, [CVS Health] can help improve access across all communities we serve,” Clapsis noted. 

Clinical trial diversity starts with patient recruitment; however, most major medical institutions that conduct large-scale clinical studies are located in cities, which means that patients in rural communities cannot access or must travel for clinical trial involvement.

“Long-standing structural issues and low patient enrollment and engagement are negatively impacting clinical trial viability and outcomes,” Clapis continued, focusing on patient recruitment issues.

Access to clinical trials can be significantly hindered by geographic location and the cost of traveling to a larger research institution.

A 2020 JAMA Network Open study found that unequal distribution of trial sites relative to population may impede patients’ participation in clinical studies and contribute to the low representation of minorities in specific trials.

More than half of patients don’t have access to clinical trials at their local treatment centers, according to the Fred Hutchinson Cancer Research Center. Notably, the average patient in the US must travel more than 25 miles to a research center.

Clapis notes that finding diverse participants who qualify for a study and are willing to go to a clinic to participate is one factor that hinders widespread clinical trial diversity. Additionally, medical center scale, clinic capacity, and patient access and retention remain challenging.

Community-Based Screening Programs

One way to improve clinical trial diversity is to incorporate community-based screening programs during participant recruitment.

In 2021, CVS Health expanded its community-based screening program to help people without regular access to healthcare understand their risk for chronic conditions and connect to free or low-cost services through Project Health.

Project Health has delivered over $134 million in free healthcare screenings to approximately 1.7 million people in racially diverse communities with large uninsured populations.

Decentralized Clinical Trials

In addition to community-based screenings, decentralized clinical trials have gained popularity since the COVID-19 pandemic. Decentralized clinical research allows patients to participate in trials from connected health centers and clinics in their community, reducing the burden of travel for trial participation.

For example, CVS Health and Medable collaborated to expand clinical trial access and engagement for patients at select MinuteClinic locations.

According to Clapsis, the collaboration combines Medable’s software platform with CVS Health’s community reach and experienced MinuteClinic providers to deliver trials that improve patient access, engagement, and retention to advance research effectiveness.

“[CVS Health] views our collaboration with Medable as a great opportunity for two innovative companies with compatible solutions to drive innovation and results in this space effectively and at scale,” he expanded.

Technology Integration

New technological advancements and digital health tools have also played a pivotal role in clinical trial diversity.

For example, CVS Health used a digital model and screening to engage over 300,000 volunteer participants who met the study inclusion criteria for a COVID-19 vaccine trial, helping connect patients to clinical trials across varying geographic locations. Additionally, incorporating telehealth into treatment protocols can also minimize the need for travel during follow-ups.

“Virtual technology in healthcare has risen to prominence during the COVID-19 pandemic,” Clapsis said. “By integrating telehealth and other virtual options into CVS Health’s Clinical Trial Services, our goal is to bring the opportunity to participate in a clinical trial, as appropriate, to the communities in ways that work best for them.”

Clapsis also highlighted the new human-centric CVS Health model, which provides flexible options to meet the needs of every person the company engages with and enrolls in a trial.

Beyond using digital health models to engage volunteers, researchers and clinical trial leaders can leverage technology, such as artificial intelligence and machine learning, in the preclinical, clinical, and post-market study phases to manage and analyze diverse datasets.

Policy Changes

In addition to strategies within individual trials, industry-wide policy changes advocating for clinical trial diversity may facilitate the recruitment of diverse participants.

Major organizations, including PhRMA and the FDA, released and updated policies to improve diversity in clinical trials. In November 2020, the FDA published final guidance encouraging clinical trial diversity from trial design to execution. At the same time, PhRMA announced the release of industry-wide principles on clinical trial diversity.

Overall, clinical trial diversity can be achieved through multiple avenues. Helping vulnerable communities access clinical trials can advance scientific discovery and optimize care for a broader range of patients.

“CVS Health can leverage advanced analytics, national reach, and local community connections to drive awareness and engagement. This leads to faster and more comprehensive trial recruitment, especially in hard-to-reach populations,” he concluded.