FSR suggests ways to boost Black representation in clinical trials
Survey-based recommendations were discussed at May 24 Congressional Briefing
Patient and physician education, trust-building, and support mechanisms are needed to reduce barriers to clinical trial participation for Black people with sarcoidosis, according to a paper by the Foundation for Sarcoidosis Research (FRS).
The white paper was titled “Ignore No More Campaign on Clinical Trials Diversity: Advancing Clinical Trial Equity for Black Patients with Sarcoidosis.”
The recommendations, developed by both patients and specialists, were based on a nationwide survey of Black sarcoidosis patients in the U.S. and were discussed at a May 24 Congressional Briefing held by the foundation.
During the in-person briefing — involving Black patients, FRS members, and a member of congress — the foundation also proposed a public policy change to tackle some of these concerns.
“We, as a society, must do a better job inviting and supporting Black American participation in clinical trials,” Mary McGowan, FSR’s CEO, said in a foundation press release. “Representation in clinical trials matters and is key to closing the gap to improve clinical outcomes for Black Americans impacted by sarcoidosis, and, indeed, all those impacted chronic illnesses.”
Highest prevalence of sarcoidosis found in Black American women
“FSR sees the release of this white paper and the Congressional Briefing as a bold first step in addressing the disparities in access to clinical trials leading to better patient outcomes,” the release stated.
In sarcoidosis, small clumps of inflammatory cells called granulomas form in different tissues and organs, affecting their function. While sarcoidosis can affect people of any race, ethnicity, or sex, Black Americans are 2.5 times more likely to have sarcoidosis than white Americans.
In addition, Black American women have the highest sarcoidosis prevalence across all groups and are twice as likely to be diagnosed than their male counterparts, who themselves experience the second highest prevalence.
However, Black Americans represent 9% of participants in clinical trials of rare diseases such as sarcoidosis compared with 70% for white participants, according to the U.S. Food and Drug Administration.
Because of all these disparities, the FSR launched the Ignore No More: African American Women & Sarcoidosis Campaign in 2021 to raise awareness of sarcoidosis among Black women and improve diagnosis, treatment, and outcomes.
In 2022, the foundation started the Ignore No More: ACTe Now! (Advancing Clinical Trial for Equity in Sarcoidosis) campaign to improve trial participation for Black patients.
As part of the campaign, the FSR conducted a nationwide, anonymous survey to understand the challenges Black and African American adults with sarcoidosis face regarding their disease, as well as their perspectives on clinical trials.
The foundation organized a Key Opinion Leaders thought workshop of physicians, researchers, and stakeholders and a patient focus group to examine the survey findings and identify recommendations to improve trial access and care of Black patients.
Among the more than 600 respondents, of whom 86% identified as female, nearly half received disability benefits or were unemployed, and 29.5% relied on transportation assistance to medical appointments.
We, as a society, must do a better job inviting and supporting Black American participation in clinical trials. Representation in clinical trials matters and is key to closing the gap to improve clinical outcomes for Black Americans impacted by sarcoidosis, and, indeed, all those impacted chronic illnesses.
Patients report great need for practical support
Regarding disease burden, 70% of patients reported having multi-organ involvement and most of them said the disease negatively affected their physical and emotional well-being, leisure activities, employment, and relationships. The need for more practical support in coping with sarcoidosis was indicated by 77%.
Most respondents also indicated that a physician’s level of disease-specific information/knowledge (90.5%), years of experience (89.7%), and transparency (84.5%) were important factors for building a trust relationship between patient and physician. These factors outweighed culture, race, and other social factors.
While patients reported that potential development of new treatments and early access to these therapies regardless of insurance were the two top benefits of trial participation, many were hesitant to be involved and only 16.7% were enrolled in clinical trials.
A lack of information about sarcoidosis trials was the main reported reason for participation hesitancy, with 61% of respondents reporting never being invited to participate in a trial. About 6% reported being asked to participate but chose not to.
The number two reason was mistrust in research based on history of discrimination, which was followed by concerns about taking time off work to participate, repercussions if employers find out about their diagnosis, and barriers associated with travel, cost, and side effects.
These findings “indicate the presumed strength of the relationship between race and discrimination may be less influential on clinical trial participation than other factors, which illuminate a viable path to engaging Black patients in clinical trials,” the foundation wrote in the paper.
Based on these insights, the two working groups proposed strategies to increase trial participation, including telehealth, expanded clinic hours, and partnering with community physicians. They also highlighted “the need for more substantial support mechanisms to reduce barriers associated with time, travel and financial burden.”
Providing tailored support to Black patients was recommended, including creating online forums and support groups led by Black patients or professionals. The creation of Black-only focus groups would be beneficial for tailored discussions on issues affecting Black patients, such as assumptions, medication costs, and healthcare access.
Educating patients, physicians about the importance of clinical trial participation
Suggestions also included creating a clinical trial alumni community and providing a trial navigator for one-on-one support, with strategies to improve care access and trustworthiness, including partnering with Black health organizations and using social media.
Developing an educational toolkit on trial enrollment and participation for patients and providers was recommended to address the need for more education on trials. This included listing patient rights, cost-benefit analysis, examples of research impact, and disease education.
Additional ideas included increasing physician education, disease awareness, and approaches to sharing trial opportunities, as well as creating pathways for Black and African American students to become healthcare professionals.
Regarding next steps, physicians should be educated on building trust with patients of color, addressing biases, and empowering patients through communication. Targeted materials should be created for Black patients to explain clinical trials.
It was also recommended that a commission of health organizations, businesses, and health institutions be built to advocate for clinical trial diversity and provide financial support for those interested in participating.
“We invite legislators to join FSR and our community partners to take big strides to improve the lives of the most vulnerable and impacted by severe chronic illness,” McGowan said.