Clinical Researcher—August 2024 (Volume 38, Issue 4)

RECRUITMENT & RETENTION

Faith Holmes, MD; Kristen Snipes, CCRA

 

 

 

Diversity in clinical research has become a hot topic in recent years, with heightened attention leading to dramatic changes in the regulatory framework. The U.S. Food and Drug Administration Omnibus Reform Act of 2022 (FDORA) is one of the most notable.{1} This landmark legislation has broadened the scope of diversity considerations in clinical trials.

FDORA mandated diversity action plans for clinical trials, requiring sponsors to establish and justify diverse patient enrollment goals and outline strategies to achieve them. This regulatory shift underscores the industry’s growing recognition of diversity’s critical role in ensuring the efficacy and safety of medical treatments across the whole population.

Now, just over a year since FDORA’s implementation, the industry’s perspective on diversity has undoubtedly evolved. However, despite this increased awareness and regulatory push, many long-standing challenges persist. The same barriers that have historically hindered diverse participation in clinical research continue to pose significant obstacles.

These persistent barriers are reflected in clinical trial participation statistics. Approximately 10.6% of participants are Black/African American compared to representing 12.6% of the U.S. adult population. Hispanic/Latino representation in clinical trials is approximately 11.6% compared to 16.7% of the population. Conversely, White participants are overrepresented, making up 77.9% of trials and 74.1% of the population.{2} Although numerous factors contribute to these statistics, the most crucial one is arguably the ongoing lack of minority accessibility to research.

While this piece focuses primarily on racial and ethnic diversity, it’s important to note that the regulations and diverse practices discussed in general also encompass sex, gender identity, age, socioeconomic status, disability, and other demographic factors.

What Factors Limit Clinical Research Access for Racial and Ethnic Minorities?

Understanding and addressing disparities in research access is crucial for improving clinical trial participation among racial and ethnic minorities. Two major hurdles stand out: 1) lack of trust and knowledge of clinical research and 2) barriers related to distance and time commitments.

The Trust and Knowledge Gap

Forty-one percent of Americans know nothing about clinical research, and 91% have never been invited to participate in a study.{3} Even among those aware of trials and invited to participate, very few consent to join. Many patients, especially those in traditionally underrepresented groups, fear being treated as “guinea pigs,” doubting that researchers prioritize their well-being.

This distrust is rooted in significant historical examples of minority exploitation, including the Tuskegee Syphilis Study (1932–1972),{4} the Guatemala Syphilis Experiment (1946–1948),{5} and the San Antonio Contraceptive Study (1969).{6} Beyond these historical traumas, many minority patients have concerns about receiving care from providers outside their communities. This apprehension can stem from several factors:

• Cultural insensitivity: Healthcare providers from different cultural or ethnic backgrounds may lack understanding of the specific needs, values, and practices of minority communities, leading to poor communication and inadequate care.
• Implicit biases: Unconscious biases among healthcare providers can result in discriminatory practices, affecting the quality of care received by minority patients.
• Social and cultural stigma: Presenting with certain health conditions or seeking help outside the community may carry stigma, deterring individuals from engaging with unfamiliar providers.

Physical Barriers

The geographic distribution of clinical trials presents another significant obstacle. Seventy percent of all clinical trials worldwide occur at just 5% of research sites, and most trials primarily draw patients from within 40 miles of their sites.{7,8} While this distance might seem manageable to some, it can be insurmountable for others. Lack of insurance, transportation issues, and financial constraints can make even relatively short distances a significant hurdle.

Time is also a major factor, including not only travel but also time spent at the site. If visits are long and/or frequent, participating while juggling other responsibilities and commitments may be difficult.

The combination of mistrust, lack of knowledge, and physical barriers limits research involvement among minority populations. This not only increases costs and prolongs timelines, it also compromises the validity of clinical data, as they fail to represent the diverse population that will ultimately use the treatments.

How Can We Increase Minority Access to Research Participation?

Innovative trial design is key to improving research accessibility, specifically through the concept of optimized trials, defined as virtual clinical trials designed to create ideal conditions for both patients and sponsors. Patients have simple, effective, and comfortable access to research as a care option, while sponsors can quickly and easily enroll and retain eligible, engaged patients.

This approach to trial design prioritizes patient experience and accessibility, which in turn can significantly increase access to research participation for traditionally underrepresented communities. By reimagining how clinical trials are conducted, optimized trials have the potential to break down many of the barriers that have historically limited minority participation in research.

Patient Trust

All patients, but especially those from racial and ethnic minority communities, ideally will develop trust and rapport with their regular medical providers. In a perfect scenario, they feel at ease and are familiar with interacting with these professionals and their teams in accessible, well-known settings.

Optimized trials boost patient understanding of and confidence in clinical research by enabling participation through trusted healthcare providers, referred to as “Healthcare-First sites.” These locations include hospitals, doctors’ offices, pharmacies, and other facilities where patients regularly receive care, and which can also function as research sites. Ideally, Healthcare-First sites receive support in their research efforts through infrastructure, training, technology, and expert insights.

As most patients rely on their healthcare provider for clinical trial information, Healthcare-First sites increase patient knowledge of research.{3} These sites allow patients to participate in trials with their own well-liked healthcare providers, who are more likely to understand their backgrounds and to be part of their communities. This in turn increases patients’ trust in clinical research.

Physical Barriers to Research Participation

Optimized trials’ use of Healthcare-First sites also helps overcome the physical barriers to research participation for underserved communities. Because these sites are where patients already go for care, they are easily accessible while considering insurance status, transportation access, and financial constraints.

However, there are still instances where trial opportunities aren’t accessible via a Healthcare-First site, patients do not have existing relationships with providers, or patients’ commitments or physical conditions make even brief site visits challenging. Optimized trials address these common barriers by integrating Healthcare-First sites with remote research solutions such as home visits, wearable devices, telehealth consultations, and other innovations. Taking a hybrid approach further emphasizes the patient’s experience and supports diverse participation in clinical trials.

Patient Identification

Optimized trials increase research diversity by aiding in diverse patient identification. While traditional clinical trial enrollment processes can be effective, they may not easily support patient identification based on demographics such as race, ethnicity, geography, or disease severity.

Conversely, optimized trials use Health Insurance Portability and Accountability Act–compliant electronic health record (EHR) data and artificial intelligence (AI)–powered analytics to target and engage with specific patient groups. The process typically starts with experts using AI technology to search an abundance of EHR data from hospitals, major health systems, and healthcare-based sites, identifying previously untapped patients. Then, careful review of each patient’s medical records makes it possible to identify only those who fit the trial criteria.

Embracing an Era of Optimized Trials

Research diversity is not only a matter of fairness; it’s fundamental to producing robust, inclusive, and impactful treatments that benefit all people. While there is still significant work to do in reducing the barriers that stand in the way of inclusive research, the industry can make substantial progress by implementing optimized trials.

Simply put, when clinical trials achieve greater diversity, they accelerate progress in medical research and treatment development. Optimized trials represent an effective way to achieve this ideal outcome, addressing long-standing issues of accessibility, trust, and representation in clinical research.

As we move forward, the widespread adoption of optimized trials could play a crucial role in democratizing access to cutting-edge medical research. By breaking down barriers and creating more inclusive research environments, we can ensure that the benefits of scientific advancement are accessible to all communities.

References

1. Consolidated Appropriations Act (H.R.2617). 2023. Committee on Appropriations, U.S. House of Representatives. https://www.congress.gov/bill/117th-congress/house-bill/2617/text
2. Flores LE, Frontera WR, Andrasik MP, del Rio C, Mondríguez-González A, Price SA, Krantz EM, Pergam SA, Silver JK. 2021. Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials. JAMA Network Open 4(2). https://doi.org/10.1001/jamanetworkopen.2020.37640
3. National Cancer Institute. Health Information National Trends Survey (HINTS) Brief 48: Public Perceptions of the Ethics of Biomedical Research: A Call for Transparency. https://hints.cancer.gov/docs/Briefs/HINTS_Brief_48.pdf
4. Centers for Disease Control and Prevention. 2022. The Untreated Syphilis Study at Tuskegee Timeline. https://www.cdc.gov/tuskegee/timeline.htm
5. Johns Hopkins Medicine. U.S. Government Study in 1940s Guatemala. https://www.hopkinsmedicine.org/guatemala-study
6. Lyerly AD. 2022. ‘Experimental pregnancy’ revisited. Theoretical Medicine and Bioethics 43(4):253–66. https://doi.org/10.1007/s11017-022-09578-z
7. Lew M. 2022. Community-Based Sites: Casting a Wider Net to Close the Data Diversity Gap in Clinical Trials. GHP News. https://www.ghp-news.com/community-based-sites-casting-a-wider-net-to-close-the-data-diversity-gap-in-clinical-trials/
8. Borno HT, Zhang L, Siegel A, Chang E, Ryan CJ. 2018. At What Cost to Clinical Trial Enrollment? A Retrospective Study of Patient Travel Burden in Cancer Clinical Trials. The Oncologist 23(10)):1242–49. https://doi.org/10.1634/theoncologist.2017-0628

Faith Holmes, MD, is Chief Medical Officer for Elligo Health Research®. She has more than 30 years of experience in direct patient care and 11 years of medical practice management, with a diverse background in Family Medicine and Hospice and Palliative Medicine spanning the continuum of the patient journey. She also has served as Principal Investigator for clinical trials at a local study site as well as for optimized virtual and hybrid study models.

Kristen Snipes, CCRA, is Executive Director, Project Delivery, for Elligo Health Research®. She leverages extensive experience in drug development and clinical management, with a strong background in project management, to bring innovative and resourceful approaches to delivering results in new environments.