Stronger Together: How Lupus Warriors Are Shaping the Future

The Lupus Therapeutics (LT) PALS Program: Empowering Lupus Patients Through Peer Advocacy and Clinical Trial Inclusion

Lupus is a chronic autoimmune disease that disproportionately affects racial and ethnically minoritized populations, particularly Black and Hispanic women. Despite this, clinical trials for lupus treatments have not been representative of diverse populations. Addressing this disparity is crucial to ensure more equitable access to cutting-edge treatments and to improve health outcomes for all patients.

One innovative solution is the LT PALS (Patient Advocates for Lupus Studies) Program, a peer education initiative designed to increase awareness, knowledge, and participation in lupus clinical trials. Led by Dr. Saira Sheikh and Dr. Sam Lim alongside the dedicated team at Lupus Therapeutics and a group of devoted investigators, designed in partnership with individuals living with lupus, the PALS program highlights the power of lived experiences in overcoming barriers to participation and fostering trust in medical research.

Racial Disparities in Lupus Clinical Trials

Dr. Saira Sheikh, MD, the Linda Coley Sewell Distinguished Professor of Medicine at the University of North Carolina at Chapel Hill, Director of Clinical Trials at the UNC Thurston Arthritis Research Center, and Chair of the Lupus Clinical Investigators Network (LuCIN), underscores a deep disparity in lupus clinical trials:

• 43 percent of lupus patients in the U.S. are Black, yet constitute only 14 percent of clinical trial participants 
• White patients, who make up 33 percent of lupus cases, constitute 51 percent of clinical trial participants

These numbers illustrate a significant representation gap, which can lead to less adequately informed treatment recommendations for the populations most affected by lupus.

Barriers to Clinical Trial Participation

Through discussions with lupus patients, the project team identified numerous barriers that prevent equitable participation in clinical trials:

1. Lack of Awareness and Access

Many patients do not know what a clinical trial is or that they might qualify for one. Dr. Sheikh recalls hearing from patients, “I had never heard of a clinical trial before. No one had ever mentioned it to me.”

2. Mistrust and Fear

Due to historical injustices in medical research, many patients—especially in Black and Hispanic communities—approach clinical trials with skepticism.

3. Logistical Challenges

Patients often face transportation issues, loss of wages, childcare considerations,  financial constraints, or scheduling conflicts that prevent them from enrolling in trials. However, as PALS members explain, many, if not most, clinical trials cover transportation, gas, and other costs—an essential detail often unknown to potential participants.

4. Provider Bias and Time Constraints

Healthcare providers may not discuss clinical trials due to implicit biases or a lack of knowledge about available studies. Additionally, time constraints in appointments often mean research discussions are deprioritized.

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A Solution Built by Patients, for Patients

Recognizing that patients trust and relate more to peers who have shared experiences, the PALS program was developed by Lupus Therapeutics and the Lupus Research Alliance, and implemented through the LuCIN Network, to serve as an educational intervention. The initiative trains individuals with lupus who have participated in clinical trials to become peer educators (PALS) and provide trial-agnostic guidance to others considering research participation.

Key Features of the PALS Program

• Formal Educational Intervention: While PALS members encourage, the program is not a chat group, or a support group, but primarily an educational intervention.
• Peer-led training: Individuals with firsthand experience in clinical trials are trained to educate others.
• Diverse representation: nine out of 11 PALS were women of color, ensuring outreach to historically underrepresented groups.
• Virtual accessibility: The program included online training, peer discussions, and a dedicated digital platform.
• Collaborative leadership: The initiative was co-led by patients and researchers, ensuring that lived experiences shaped program development.

Measurable Success and Lasting Impact

The pilot phase of LT PALS was implemented at five clinical sites and included 136 participants:

• 64 participants engaged with a PAL (intervention group), while 72 served as controls
• 77 percent of participants remained engaged one year later, showing the long-term impact
• 47 percent of participants took steps toward trial participation, including:
  • 37 percent discussing clinical trials with their healthcare provider
  • 17 percent screening for a trial
  • 10 percent enrolling in a trial, with 62 percent of those enrollees identifying as Black

These results show the program’s effectiveness in increasing knowledge, confidence, and potential for participation in lupus clinical trials.

Enhancing Clinical Trial Accessibility

Dr. Sheikh emphasizes that the biggest takeaway from this program is the need to increase awareness, access and opportunity when it comes to clinical trials.

“If you don’t have knowledge and awareness about clinical trials, how are you going to access them?” she explains. “Many patients simply don’t know clinical trials exist, or that this could be an option for them.”

1. Addressing Everyday Barriers

Through this program, patients shared day-to-day challenges that influence trial participation, such as:

• Transportation issues → Solution: Educating patients that clinical trials cover transportation costs
• Childcare responsibilities → Solution: Advocating for trials that offer caregiver stipends
• Work conflicts → Solution: Promoting trials with flexible scheduling and compensation for missed wages

2. Bridging the Knowledge Gap

To ensure that PALs were well-prepared, they received formal training in clinical trial processes, oversight, and patient rights. This allowed them to answer common concerns, such as:

• Who regulates clinical trials? → Institutional Review Boards (IRBs) ensure ethical standards.
• Are clinical trials safe? → Strict oversight mechanisms in place to protect participants.

By providing both formal education and lived experience, PALS were uniquely positioned to build trust and dispel misconceptions.

3. Supporting Doctor-Patient Conversations

Since 77 percent of patients learn about clinical trials from their doctors, PALS also highlighted ways to improve provider-patient communication:

• Training healthcare providers on how to effectively introduce clinical trials.
• Encouraging patients to advocate for themselves by asking their doctor:
  
  

“Are there any clinical trials that might be right for me?”

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Dr. Sheikh emphasizes that patients and providers must work as partners:

“We want our patients to feel empowered to ask questions and be active partners in their care to advance health and healing”

A Community of Advocacy and Support

Beyond statistics, the human impact of the LT PALS program is what makes the endeavor truly transformative.

“It shows you how committed individuals living with lupus are to helping others,” Dr. Sheikh says, reflecting on the dedication of PALS members.

The initiative created a tight-knit community where lupus patients supported one another through shared experiences, cultural humility, and mutual empowerment.

Future Directions: Scaling LT PALS and Transforming Clinical Trials

Given its success in increasing diversity in lupus clinical trials, the LT PALS program serves as a model for patient-centered research.

• Expansion to other diseases: The peer advocacy model could be applied to other underrepresented patient groups.
• Increased virtual access: Digital platforms will extend the program’s reach.
• Collaboration with healthcare providers: Integrating clinical trials into routine medical visits.

Dr. Sheikh believes true transformation in clinical research requires innovative solutions: “For clinical trials to be truly equitable, we must rethink how we engage and empower patients—placing them at the heart and center of healthcare, research and all that we do.”

Conclusion

The Lupus Therapeutics PALS program is a groundbreaking initiative that empowers lupus patients through peer education and advocacy. By bridging the gap between patients and clinical trials, LT PALS is paving the way for more inclusive and effective research.

This program proves that when patients are engaged as partners, the entire healthcare system benefits—leading to better treatments, stronger communities, and a more just medical landscape.

If you are interested in learning more, the LT PALS study findings are available as an open-access resource, ensuring that this critical knowledge remains accessible to the lupus community and beyond.