Why Diversity in Clinical Trials Matters for Lupus Patients Like You

Clinical trials are key to discovering better lupus treatments — understanding what works, what doesn’t, and how to make care safer and more effective. But here’s the catch: if these trials don’t include people from all backgrounds, the results might not reflect the needs of the people most affected by lupus.

Lupus is a complicated autoimmune disease that doesn’t look the same for everyone. It impacts people differently based on their gender, race, ethnicity, and even where they live.

New treatments are desperately needed to improve the quality of life for people living with lupus, but without diverse participation in clinical trials, researchers may miss how treatments work — or don’t work — for everyone.

“Diversity is super important in clinical trials,” says Philip Mease, MD, a Seattle-based rheumatologist and principal investigator in several clinical trials. “It makes sure the results apply to everyone, no matter their race, gender, age, or background. This helps make treatments safe and effective for all kinds of people. The more diverse the trial participants, the more information there is to see if and how well the study medication works on different populations.”

Who Is Missing from Clinical Trials?

One of the biggest challenges in lupus research is that clinical trials often exclude the communities most affected by the disease.

For instance, Black people represent 43 percent of systemic lupus erythematosus (SLE) cases but only make up 14 percent of clinical trial participants. That’s a major gap.

“Lupus disproportionately affects people of color,” explains Swamy Venuturupalli, MD, FACR, a rheumatologist and founder of Attune Health. “African Americans, Native Americans, and Latinos are among the hardest-hit groups, and they also face challenges with traditional therapies.”

The stakes are especially high: lupus is one of the leading causes of death for Black and Hispanic women between the ages of 15 and 24. Including diverse participants in clinical trials is essential to ensure treatments are tested for — and tailored to — the people most affected by the disease. “By offering cutting-edge therapies through clinical trials, we can address these disparities,” Dr. Venuturupalli adds.

“When we look at lupus specifically, it’s predominantly women of color,” says Irene Blanco, MD, a rheumatologist at Northwestern Medical Group, noting that these patients tend to skew younger, may have the potential to become pregnant, and may have different levels of health literacy. Unfortunately, biases can lead to assumptions that they won’t participate because they don’t understand or won’t adhere to treatments — without really understanding why patients are not adherent to their medicines.

“Because of these biases, you’re not including the patients who are most likely going to need these medicines,” says Dr. Blanco. “And so you’re not going to know, for example, their perspective on the medicines, how easy this is going to be to take for them. You’re not getting the full, robust spectrum of data needed to develop treatments that work for everyone.”

Making Participation Easier for All

Improving diversity isn’t just about recruiting more people — it’s about creating an environment where patients feel supported and valued.

• Addressing barriers: Researchers and clinicians must actively reduce barriers to participation, such as logistical challenges, cultural differences, and misconceptions about clinical trials. “We as providers need to be more aware — not just of medications or treatments — but more aware of where our patients are living, what they’re going through, and try our best to advocate for better circumstances for all of those patients,” says Sharon Dowell, MD, Associate Professor of Internal Medicine at Howard University.

• Tailored communication: Building trust with patients starts with culturally sensitive communication. “When I start speaking to a patient in Spanish, you can see their whole demeanor shift. They feel at ease,” says Dr. Blanco. This kind of connection helps patients feel seen, heard, and respected, encouraging participation in historically underrepresented communities.

How Does Diversity Make a Difference?

Diverse clinical trials can improve safety, accessibility, and trust in medicine.

Better Treatment Results

“When these therapies are coming out into the community, these are the people who are going to need them most,” says Ashira Blazer, MD, Assistant Professor in the University of Maryland Division of Rheumatology and co-director of the Lupus Center at the University of Maryland School of Medicine. Including people from different backgrounds in clinical trials ensures doctors know how well treatments work for everyone.

Safer Medications

Different groups may experience different side effects from the same treatment. Including diverse participants helps researchers identify and address these risks.

“Some therapies work better for certain ethnicities over others,” notes Dr. Venuturupalli. “There’s no way for us to know if a particular therapy might work in a person of color unless it’s tried in people of color through a clinical trial process, which is a safe, regulated way to try a new therapy.”

Real-World Data

Trials that include diverse populations reflect the realities of lupus patients. When we look at the landscape of who commonly is included in a clinical trial, we see they often do not represent the patients who are most affected by the disease,” says Dr. Blanco.

Building Trust

“When people see trials that include participants who look like them, they’re more likely to trust the results,” says Dr. Blanco. “It’s all about creating a space where patients feel seen, heard, and respected.”

How You Can Help Improve Diversity

As a lupus patient, you have the power to help improve diversity in clinical trials. Here’s how:

• Talk to your doctor: Ask if clinical trials might be right for you and what’s involved.
• Learn more: Research trials in your area and see if any align with your needs.
• Encourage others: Share information with friends, family, and your community to spread awareness.

If you’re considering joining a trial, talk with your doctor about what’s involved. Remember, participating in a trial doesn’t mean you’re committing to anything long-term — it’s all about finding what works best for you and your lupus journey.

“Think about clinical trials as a choice — when you think about all of the treatment options that are presented to you when you are at the doctor’s office,” says Saira Sheikh, MD, Director of the University of North Carolina Rheumatology Lupus Clinic. “Think about a clinical trial as another option by which you may be able to advance your health.”

The bottom line: Diversity in clinical trials isn’t just a nice-to-have — it’s essential. By including people from all backgrounds, we can develop better treatments that reflect the real-world needs of the lupus community. Together, we can help ensure that every patient, no matter their background, has access to the care they deserve.

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This article was made possible with support from Bristol Myers Squibb.