Rare Community Profiles is a Patient Worthy article series of long-form interviews featuring various stakeholders in the rare disease community, such as patients, their families, advocates, scientists, and more.
#RAREis: Advancing Clinical Trial and Patient Equity with the Foundation for Sarcoidosis Research’s Mary McGowan
While clinical trials can be valuable tools in understanding diseases and identifying potentially life-changing treatments, participation in these trials is often fraught with barriers. Access to care, inclusion of diverse voices, geographical challenges, and financial concerns such as travel costs can all play a role in excluding individuals from getting involved in clinical studies.
“Achieving equitable access to clinical trials is a pressing concern, especially for those with rare diseases such as sarcoidosis,”says Mary McGowan, the CEO of the Foundation for Sarcoidosis Research (FSR). Sarcoidosis is already a disease with disparities:
“African-Americans, and African-American women in particular, have the highest prevalence of sarcoidosis and the worst outcomes. The Black community is 2x more likely to have sarcoidosis than white Americans, has 9x more hospitalizations, has more pulmonary and extrapulmonary disease involvement, has a 12x higher mortality rate, and tends to die younger from this disease. Yet these individuals are missing from clinical studies, leaving the sarcoidosis community with significant unmet needs. The Foundation for Sarcoidosis Research is on the frontline of advocating for sarcoidosis patients and leading the charge to ensure more equitable participation in trials. We consider our work as urgent with increasing importance as sarcoidosis is on the rise.”
By sharing her experiences through Amgen’s #RAREis program, a campaign designed to elevate the voices, faces, and experiences of the rare disease community, McGowan and her team at FSR are raising awareness, dismantling barriers, and advocating for policy changes that promote inclusivity in clinical trial enrollment and beyond. Today, McGowan discusses with Patient Worthy the challenges in sarcoidosis management, the inequities in this community, and why she’s proud to be part of #RAREis.
About Mary McGowan
Mary McGowan’s personal journey has fueled her commitment to patient advocacy. At age five, McGowan’s doctors were preparing her for a tonsillectomy when they came across a surprising finding: a large oral tumor that physicians worried was cancerous. Further testing showed that the rare tumor was actually benign.
Still, McGowan spent a month at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins as she underwent treatment. It was here that she was, as she explains:
“Exposed to serious illness and disabilities. A mental health counselor described it as living in a war zone: all the children fighting for their lives. This had a profound impact on me. I knew, from that early age, that I wanted to give back to others based on this experience and speak up for patients and children in need.”
After receiving her BA in Psychology from Trinity Washington University and her MA in Human Resources Development from The George Washington University, McGowan turned her sights towards the American Academy of Pediatrics; she spent 20 years performing outreach and working to transform the pediatric medical space.
In the fifteen years since, McGowan has continued her nonprofit patient advocacy as the Executive Director of the Allergy and Asthma Network, CEO of WomenHeart, Executive Director of the Myositis Association (her first entrance into rare disease), and, since 2020, the CEO of the Foundation for Sarcoidosis Research.
Foundation for Sarcoidosis Research
The Foundation for Sarcoidosis Research explains that it is:
“The leading international organization dedicated to finding a cure for sarcoidosis and improving care for sarcoidosis patients through research, education, and support. Since its establishment in 2000, FSR has fostered over $6 million in sarcoidosis-specific research efforts.”
FSR offers numerable resources and educational materials for physicians, patients, and caregivers alike, including information on sarcoidosis, physicians’ treatment protocols, wellness and self-care tips, a provider directory, the FSR Sarc Fighter podcast, peer-led Community Groups, and the FSR Sarcoidosis Support Group. McGowan stresses the importance of opportunities to bring the community together:
“People with sarcoidosis face challenges like a lack of awareness, misinformation within the medical community, and issues with receiving an accurate and early diagnosis. Sarcoidosis, like other rare diseases, is all about exclusion: you go through a number of tests for other diagnoses until they reach sarcoidosis. I also speak with patients who discuss how sarcoidosis, as an invisible disease, makes them feel pain, fatigue, and other symptoms even though they look outwardly healthy, making it harder to have family and friends not only understand what they’re going through, but believe that they’re going through it. As you can imagine, this makes the mental health aspect of managing sarcoidosis really challenging. People feel isolated and alone. I believe that it’s important for advocacy groups to create avenues for people to connect with others, which is what we aim to do with our support groups.”
Outside of connecting the patient community with each other, FSR also works to foster cooperation and knowledge exchange more broadly with the ultimate goal of advancing research and care on a global scale. Two years ago, FSR also launched the Global Sarcoidosis Clinic Alliance, a collaborative platform aimed at uniting medical institutions, clinicians, and patients worldwide. Today, the Global Sarcoidosis Clinic Alliance consists of 42 clinics, hospitals, individual providers, and more who are committed to finding a cure and providing evidence-based care. Says McGowan:
“The Global Sarcoidosis Clinic Alliance was a response to challenges and unmet needs we saw within the sarcoidosis community. We interviewed several doctors and their responses mirrored those we heard from patients: feelings of isolation, working in a silo, fighting for money and resources. Our goal was to bring them together to discuss best practices. This program includes peer case review sessions, a journal club specific to sarcoidosis, grand rounds specific to sarcoidosis, and a clinical education series. We also offer a mentorship program where clinics or hospitals that are further along in their mission can help newer members flourish. Collaboration is really the spirit upon which we work. We believe that this collaboration helps to raise all boats, if you will, in terms of moving sarcoidosis research forward, but also speaking up for rare diseases: not just individual, but collective.”
The Fight for Improved Equity
As the medical community continues to grapple with the complexities of rare diseases, the work of FSR serves as a beacon of hope, driving forward initiatives that hold the potential to uplift and transform the landscape of sarcoidosis research and patient care. One tenet of this mission is improving medical equity, especially within the clinical trial space. The FSR pursued this through its “Ignore No More” campaign—a five-month, first-of-its-kind African American Women & Sarcoidosis National Campaign (AAWS).
In the first portion of its campaign, the FSR developed a Women of Color Patient Advisory Committee, as well as launched a social media campaign designed to raise awareness of sarcoidosis as it impacts African-American women.
The second phase of the campaign, Advance Clinical Trials for Equity (ACTe Now!), included a national IRB-approved survey sent out to Black sarcoidosis community members nationwide which asked these individuals to share their experiences with sarcoidosis, as well as their knowledge and perspective on clinical trials. McGowan shares:
“We were hoping for 200 responses, but our community blew us away. Altogether, 406 individuals responded to the survey, providing us with robust data to inform our understanding of clinical decision-making. We used these insights to put together a Key Opinion Leaders Thought Workshop which led to recommendations on breaking down some of the barriers identified in the survey, such as issues with childcare, rural locations, not getting time off work, or not being given information on clinical trials. Only a very small percentage of the community we surveyed had been asked to participate in clinical trials and did not. Most individuals stated they had not been asked or given the opportunity, so that’s a critical point for us to recognize and focus on.”
Following the workshop, FSR aggregated a patient-focused group which reacted to the recommendations and added their own, leading to the development of a 60-page white paper that was launched at a congressional briefing on Capitol Hill. The paper was met with widespread bipartisan support. Some of the inclusions in the paper, McGowan shares, include:
“Changes to the FMLA, such as job security and paid time off, so that people who enroll in clinical trials would not lose their jobs, as well as a $5,000 tax credit for Americans who participate in clinical studies.”
#RAREis: An Opportunity for Increased Awareness
The campaign is now in Phase 3; the FSR is putting together a commission of partners to work with the organization on these national committees. So far, their partnerships span 26 groups and have led to the formation of a steering committee. Says McGowan:
“We will be working collaboratively to make significant national change. Our goal is to open the door and break down the barriers for underserved communities to enroll in clinical trials, which is critically important.”
As part of her awareness efforts, McGowan participated in Amgen’s #RAREis program. The #RAREis program not only highlights changemakers in the rare disease community, but provides valuable resources, education, and support to rare disease patients and families as they navigate the uncertain road ahead of them. McGowan shares:
“I am happy to participate in #RAREis because it helps to amplify the voices, faces, and stories of those living with rare diseases, as well as to provide resources that encourage and empower others. We feel very strongly at FSR about the patient story and providing opportunities to those who are interested in sharing their stories. Receiving the #RAREis Global Advocate Grant was an honor and provides us the opportunity to advance sarcoidosis research and insight into unmet needs and to collaborate on unmet needs for people with sarcoidosis.”
The #RAREis Global Advocate Grant provides $5,000 in grant funding to small, often underserved advocacy organizations supporting the rare disease community around the world. If anybody is looking to learn more about sarcoidosis, or to collaborate with the FSR on its mission, McGowan encourages them to please reach out and join in on their effort.
