By: Scott Gray – Co-Founder and CEO – Clincierge
The medical community and cultural opinion agree: clinical trials need diversity. It’s our job to serve affected populations, but we cannot do that if we don’t have an appropriate representation of these populations in our research. Minorities are often more at risk for disease yet are egregiously underrepresented in clinical trials. In 2020, 53 new drugs were approved by the FDA, but 75% of clinical trial participants were white, and just 11% were Hispanic, 8% were Black, and 6% were Asian(1) – a significant underrepresentation of Black and Hispanic populations. Understanding why and how minority populations are underrepresented can lead us to define actionable steps that organizations of all sizes can take to help solve the problem.
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Understanding the Lack of Diversity in Clinical Trials
Historically, the vast majority of clinical trial participants have been white males – the demographic that could afford time off from work and away from family, as well as pay out-of-pocket for travel to and from research sites. White patients in the U.S. typically have more resources, language skills, and research tools to find clinical trials that could benefit them and more support should they choose to participate.
Minority populations, on the other hand, are both less likely to be referred to a clinical trial and less likely to participate once aware of trial options as a result of barriers like finding childcare or making a long commute. Even with reimbursement for food and travel, the other costs of participation are difficult to overcome. Consider that patients are 27% less likely to participate in clinical trials if they make less than $50,000 per year and the median income for Black households was $40,000 in 2017, while non-Hispanic white Americans reported making $68,000.(2)
Besides monetary reasons, other barriers to participation have decreased diversity in clinical trials. Not only are minority populations more likely to have a disease requiring medical attention, they are more likely to have multiple medical conditions. Stringent pre-qualifications for participation often preclude patients from having other pre-existing conditions.
Additionally, underserved populations tend to have a higher level of mistrust for the healthcare community. Famously, researchers in the Tuskegee Syphilis study withheld treatment from Black men without consent in order to study the course of the disease, resulting in lasting mistrust of the medical system. More recent studies show that Black patients are less likely than white patients to receive medical care for the same symptoms.(3)
The discrimination and mistrust of the system apply to other populations; thousands of Native American women were sterilized without their consent between 1973 and 1976.(4) To overcome these barriers, the burden of responsibility is on pharmaceutical companies and CROs to purposefully recruit, provide support, and build trust with minority populations. Only when we intentionally address each challenge will clinical trial diversity expand to reach appropriate levels.
Manageable Steps for Improving Minority Recruitment and Participation
Perhaps the most straightforward action we can take is addressing the financial challenges prospective participants face. Informing underserved populations about compensation and travel stipends that are available can garner participation. And, investing in increasing those funds can also improve recruitment by addressing the income and resource gap. Additionally, providing prepaid travel arrangements and rapid reimbursements for out-of-pocket expenses takes the burden off of patients and caregivers unable to take on upfront costs of participation. Partnering with a patient logistics management company that provides personalized patient services – including financial assistance – catered to individual needs will achieve these goals.
In the U.S., recruitment representatives should also discuss existing resources such as the Ensuring Access Act, which deducts the first $2,000 a patient receives for clinical trial participation from federal benefit eligibility determinations. If a potential participant doesn’t feel like the other benefits that they count on are threatened, it will be easier for them to join a study.
Thought should also be given to the design of trials to make participation less burdensome for participants. Increasing site locations in minority neighborhoods and holding recruitment events during the weekend and evening hours are simple ways to make trials more accessible. Consulting patient advocacy groups, patients, caregivers, and physicians for input regarding any trial steps that require adjustment to improve the patient experience, can also help improve trial design to attract and retain diverse populations.
Purposeful education and intentional communication are also vital to generating interest in target communities. Companies can begin by engaging community influencers to help communicate the importance of trial participation and the specific financial benefits participants receive, and to reassure prospective participants that the company is taking steps to make participation less burdensome. It is essential to then provide direct support to participants beginning with recruitment and continuing throughout the clinical trial length. This continuity provides reassurance and builds trust. To enact this education, consider dedicating resources to community outreach including engaging community leaders in target populations to serve as knowledge ambassadors.
Education doesn’t end with target populations, however. Pharmaceutical companies and CROs should communicate the importance of diversity and the clinical need for its pursuit. These companies should train their staff in cultural safety and awareness. Implicit bias is unavoidable, but companies can adopt several policies and standards to mitigate its harmful impacts. Consider mandating training in areas such as understanding the patient perspective, health literacy and language barriers, education on health system bias, and using the correct terminology. Starting at the root of the problem with recruitment can be far more effective long term than addressing individual symptoms.
After recruiting a diverse participant population, partnering with a patient logistics management company can provide the ongoing support to participants that is required to overcome barriers that arise throughout the clinical trial and improve retention of diverse populations in trials.
Challenges of Achieving Diversity in Rare Disease Trials
Many of the steps discussed for minority community outreach don’t have the same effect in the rare disease space. Reaching out to an entire community isn’t necessary when just one or two patients may be target participants. Instead, recruiting individual participants to create a diverse cohort becomes essential to achieve a representative sample.
With that comes the need for more dedicated resources. In trials like these, offering personalized support for patients and caregivers becomes one of the only ways to recruit and retain the patient population required for a study. With a geographically dispersed patient population, travel becomes unavoidable, and services like currency exchange and translation become necessary parts of the process. For example, in studies involving children, entire families may need to relocate to a different country for an extended time via medical aircraft. Income, language, or other barriers shouldn’t stop a patient from participating, so ensuring support and communication is a fundamental element of every step throughout the trial process – from recruitment to retention.
These complex cross-border situations are another area where patient logistics companies can most efficiently provide support. By partnering with one of these companies, trained coordinators provide one-on-one services including cross-border support, document procurement, cross-currency reimbursement, and translation and interpretation services to clients of all demographics, locations, and medical conditions.
The complications that come with extended travel and intensive medical needs increase the chance of patient attrition. With such a small pool of potential participants, retaining each patient is of critical importance. Considering the financial and timeline cost of losing a patient, providing services to support diverse populations is a good business investment – not to mention an ethical responsibility to address a medical need for a member of an underserved demographic.
Other Diversity-Increasing Benefits of Patient Coordinators
Besides providing specialized services for global studies and rare disease patients, patient coordinators from patient logistics management companies can also improve diversity through their trained approach and attention to patient services. Much of the work in recruiting and retaining diverse candidates is in building relationships with patients. Partnering with a company that provides trained patient coordinators effectively gives culturally relevant support and stabilizes a clinical trial.
Patient coordinators minimize the burden of participation by managing logistics and advocating for the patient throughout the clinical trial. Coordinators are assigned to each participant throughout the entire trial to provide personalized support for travel, financial prepayments or reimbursements, relocation services, and other logistical management.
Since this role is so vital, selecting the right patient services company for your study is a critical step in the process. You want to ensure that the company you choose provides highly personalized services to patients and has specialized coordinators that can match the needs of your targeted communities. For instance, selecting a partner that can match each participant with a coordinator in their location or time-zone and with the same culture and language can dramatically improve retention rates. This approach builds trust and allows patients and caregivers to focus on their health. Additionally, it enhances satisfaction with the entire clinical trial experience while reducing the logistical burden on clinical trial staff. A positive experience also opens the door for other members of the community to participate in the future.
The Lasting Impact of Purposeful Representation in Clinical Trials
Though achieving a representative sample in clinical trials is a daunting task – and we have a long way to go to get there – the results of success will be staggering. Black people are at higher risk than white people for developing heart disease, cancer, stroke, diabetes, asthma, and even mental health problems.
The American Cancer Society estimates more than 600,000 Americans will die from cancer this year, with Black Americans having the highest death rate and shortest survival of any racial or ethnic group.(5) Despite these staggering statistics, they are continually underrepresented in clinical trials to develop treatments for these conditions. For example, in clinical trials for the FDA-approved multiple myeloma drug ixazomib, only 1.8% of participants were Black. However, Black people are twice as likely as their white counterparts to contract this particular cancer; 1 in 5 people diagnosed are Black.(1)
Addressing this disparity improves scientific results by allowing researchers to understand how a new drug or therapy affects individuals of all demographics. Understanding if a drug affects a specific population differently is critical to moving medicine forward safely and equitably. Discovering these differences in the trial phase is far safer – ethically and financially – than realizing any adverse effects or lack of efficacy after a product has gone to market.
Our research will be more comprehensive and better positioned to serve populations across community lines when demographic or socioeconomic standing has no bearing on clinical trial participation and representation.
The Time to Act is Now
Standing up for diversity in clinical trials is both a business and ethical responsibility, as well as a commitment to those we serve. It is within our abilities as a medical community to invest in tools and resources to improve community outreach and eliminate barriers to participation. By prioritizing education and relationship-building, we can recruit and retain a more diverse population for clinical trials – moving medicine forward in an equitable way.
References
- Young S. Paving the Way for Diversity in Clinical Trials. WebMD. March 23, 2021. Accessed April 15, 2021. https://www.webmd.com/lung/news/20210323/paving-the-way-for- diversity-in-clinical-trials
- Burke CW. The Importance of Diversity in Clinical Trials (Because Right Now, It’s Lacking). BioSpace. October 10, 2018. Accessed April 15, 2021. https://www.biospace.com/article/ the-importance-of-diversity-in-clinical-trials-because-right-now-it-s-lacking-/
- Scharff DP, Mathews KJ, Jackson P, Hoffsuemmer J, Martin E, Edwards D. More than Tuskegee: understanding mistrust about research participation. J Health Care Poor Underserved. 2010;21(3):879-897. doi:10.1353/hpu.0.0323
- 1976: Government admits unauthorized sterilization of Indian Women. National Library of Medicine. Accessed April 15, 2021. https://www.nlm.nih.gov/nativevoices/timeline/543. Html
- Facts & Figures 2021 Reports Another Record-Breaking 1-Year Drop in Cancer Deaths. American Cancer Society. January 12, 2021. Accessed April 15, 2021. https://www.cancer. org/latest-news/facts-and-figures-2021.html
About the Author
Scott Gray is co-founder and CEO of Clincierge, a provider of patient logistics management for clinical trials. He is a recognized leader and innovator in the world of medical meetings, patient-centered clinical trial support, and healthcare logistics. Scott is dedicated to improving patient-centricity in clinical trials and general medical treatments.
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