The clinical trial industry has been slow to respond to the prevailing lack of racial and ethnic Diversity in Clinical Trial participants, and this longstanding challenge of under representation in clinical research has only been underscored by the outcomes of the pandemic. Trial participation fell among people of color in 2020, with Hispanic representation dropping a full seven points from 18% to 11%. During this same period, racial and ethnic minorities were much more likely to die from COVID-19 than white population groups.
These trends are unacceptable, not just from a scientific standpoint but from a moral and ethical one. Sponsors are recognizing the urgent need for transformative change to improve diversity, equity, and inclusion in clinical trials. This increasing awareness, accompanied by the call for mitigating actions, has contributed to the rise of decentralized clinical trials (DCTs), which offer an important avenue for expanding access to underserved populations. Read on to explore how DCTs are evolving the industry status quo on inclusion.
Underrepresentation of diversity in clinical trials begins with a long history of mistreatment at the highest levels of research and healthcare. Studies such as the U.S. Public Health Service Syphilis Study at Tuskegee posed major ethical issues that continue to fuel medical mistrust. To this day, people of color may perceive trials as “experiments” that harm, not help, them.
However, historical precedent doesn’t fully address the foundation of underrepresentation. Research suggests that while racial and ethnic minorities are just as willing as whites to participate in health research, they far are less likely to be invited to do so.
Further research published in the journal Cancer supports this assumption. After interviewing stakeholders at five U.S. cancer centers, researchers concluded: “Not only did some respondents view racial and ethnic minorities as less promising participants, some respondents reported withholding trial opportunities from minorities based on these perceptions.”
To combat these blatant discriminations, the industry and healthcare providers must undertake more concerted efforts to engage minorities. Areas of opportunity to which these efforts could be directed are legion. Numerous studies show that inequities persist across many disease states and therapeutic modalities:
Black, American Indian or Alaska Native, and Hispanic or Latino adults were underrepresented in vaccine clinical trials, compared with the broader U.S. population, according to a study in the Journal of the American Medical Association that examined 230 U.S.-based trials of all phases.
According to the Journal of Oncology Practice, African Americans represent 13.3% of the general U.S. population but comprise only 5% of patients enrolled in clinical trials that support U.S. Food and Drug Administration approval of new drugs. Additionally, “[c]ancer is the leading cause of death for Asian Americans, yet this population comprises 3% of cancer clinical trial participants. Hispanics are also similarly underrepresented in clinical trials.”
“African Americans are at higher risk of multiple myeloma (MM) yet are underrepresented in clinical trials and reap fewer benefits from novel therapies of the disease,” according to a study in Blood Cancer Discovery. Researchers noted: “Due to underlying genetic and biological differences between African Americans and whites with MM, it is possible that clinical trials may not adequately characterize either the safety or efficacy of approved drugs in these patients.”
“Black patients constitute less than 4% of all patients enrolled across multiple trials that supported the approval of immune checkpoint inhibitors for the treatment of lung cancer,” with similar trends in renal carcinoma and other tumor types, according to research published by the American Society of Clinical Oncology.
To instigate real progress, the industry must first recognize that diversity in clinical trials is a matter of health equity. Giving everyone a seat at the table is imperative to developing treatments that meet patients’ needs.
Research in the Journal of Oncology Practice underscores this necessity, noting that “[d]elivering personalized medicines that account for biologic factors, such as genetics, gender, race, and ethnicity, is fundamental to the goal of precision medicine; however, without including adequate representative patient populations, this goal is not achievable.”
People of color must be represented at all stages of therapeutic development, particularly for diseases that affect them disproportionately. For example, African American patients are generally at higher risk for heart diseases, stroke, cancer, asthma, influenza and pneumonia, diabetes, and HIV/AIDS than their white counterparts, according to the Office of Minority Health. However, clinical research participant pools do not often reflect the prevalence of disease states in the actual population as they should.
The FDA has been addressing this issue since the 1980s, and its recent mandates on diversity are pressuring sponsors to demonstrate real efforts, not just intentions. The New England Journal of Medicine has followed suit, requiring researchers to provide diversity statements along with their article submissions.
Major sponsors, such as Pfizer and Amgen, are also responding to these shifts, making diversity a tangible priority and recognizing their business and ethical obligations to do so. And, PhRMA’s Equity Initiative is advocating for “necessary systemic and long-term change to meet the needs of Black and Brown America.”
As sponsors increasingly acknowledge the problem of underrepresentation in clinical research, how can they commit to being part of the solution? One avenue is to consider a decentralized clinical trial (DCT) as a means of bridging the gap between sponsors and historically underrepresented participants. DCTs bring studies directly to participants, removing many traditional barriers to inclusion and allowing sponsors and clinical research organizations to:
• Recruit, enroll, engage, and support participants where they are—lowering the burden of geographic or scheduling barriers and creating a safe, accessible environment.
• Generate and provide access to real-time data to ensure studies are hitting the mark with diverse participant pools.
• Allow for greater flexibility. For example, the need to more easily modify the study protocol based on input from trial participants.
ObvioHealth regularly works with clients to achieve diversity in clinical trials. In their recently conducted hypertension study, African American participants represented nearly 42% of the study population. And, in a recent ObvioHealth dermatology study, more than 60% of participants were Asian, reflecting the higher incidence of a specific skin condition within this population. These statistics prove that it is possible to recruit and retain minorities—if sponsors are committed to doing so.
ObvioHealth proposes some best practices for promoting diversity in studies:
To support the success of the study overall, it is important to design the study in an inclusive way and to set realistic targets for representation across racial and ethnic populations based on the disease state and treatment being studied. Eligibility criteria that limit participants with comorbid conditions are a major hurdle to increasing diversity, according to the FDA—and sponsors may need to revisit these criteria. Language and technology are other important factors; to state the obvious, a trial that is designed in English will immediately exclude non-English speakers; a design that requires a Wi-Fi connection for all reporting, versus one that allows for offline recording and upload, may exclude lower-income communities who don't have constant access to the Internet. Details like these need to be incorporated from the outset to maximize the potential for inclusion.
Work with an experienced digital recruitment team to reach prospective participants based on factors such as audience geography and affinities. Campaigns should be built on participant/patient insights into trial motivations and barriers and should feature inclusive messaging and imagery to help people feel that studies are relevant to them. Targeting a more diverse audience can impact overall study costs, but online recruitment for DCTs offsets this premium due to its cost efficiencies.
Building trust is essential to recruiting and engaging participants from underrepresented groups. For offline studies, identification of champions who can discuss the benefits of trial participation in their communities is key. Cancer researchers suggest meeting patients where they are: churches, “village elders,” celebrities, support groups, and social media. For both offline and online studies, it can also be important to ensure a diverse study team that reflects the population with whom they work. Research conducted by the Tufts Center for the Study of Drug Development demonstrates that “clinical trial diversity is closely linked with the diversity of site staff.” Of course, representation is not everything. Study teams and sponsors must also be willing to consider modifications to trial protocols when patient input suggests there may be important hurdles to inclusion. Fortunately, DCTs offer the real-time insight and feedback loops, as well as more flexible designs, that can facilitate any required changes.
Study participants need to feel supported throughout the trial to improve engagement and compliance—decentralized trials are no exception. ObvioHealth’s team checks in with participants via online chats, texts, and phone calls to answer questions, address concerns, and remind participants of upcoming study tasks.
DCTs are not universal solutions for improving diversity—for instance, lack of broadband Internet in some areas can limit participation in virtual trials. It is also important to note that participant diversity is multi-faceted: age, gender, socioeconomic status, physical and mental ability, geography (rural vs. urban) and more are all diversity categories. Intersectionality across these dimensions can affect how people perceive and participate in trials. However, DCTs are a proven method of meaningfully addressing issues that have historically hindered people of color, and other underrepresented groups, from participating in trials.
Increasing diversity, equity, and inclusion in clinical trials is both a moral imperative and a business differentiator. The most forward-thinking sponsors are already defining the future of engagement—and shifting the industry will require an overhaul of the status quo. Decentralized trials offer a promising avenue for real change, and sponsors striving to lead the industry in systemic transformation have an incredible opportunity to do so with virtual, and ethical, innovation.