Turning the Tide in Lupus Treatment: Clinical Trials as Standard of Care

People living with lupus can have early access to innovative therapies alongside personalized support from a broader care team.

How? Through participation in clinical trials. 

Historically, clinical trial participation for lupus was discussed only after standard treatments failed the patient. Now, Lupus Therapeutics, the clinical affiliate of the Lupus Research Alliance, is working to make clinical trial participation routine.

Saira Sheikh, MD, Chair of the Lupus Clinical Investigators Network (LuCIN), overseen by  Lupus Therapeutics, and the Linda Coley Sewell Distinguished Professor of Medicine at the University of North Carolina (UNC) at Chapel Hill, is a nationally recognized physician, researcher, and educator. She is trained and triple board certified in Internal Medicine, Rheumatology & Allergy and Immunology. Dr. Sheikh is a strong advocate for making clinical trial discussions a normal part of day-to-day patient care—expanding access to innovation, improving patient representation, and empowering both patients and healthcare providers.

Hear her perspective on how clinical trials can reshape lupus treatment for people today and guide the development of better treatments for the entire lupus community tomorrow.

You are a strong advocate for making lupus clinical trials a normal part of patients’ day-to-day care. What does this mean, and why is it significant for lupus patients, healthcare providers, and researchers?

This means that in everyday clinic visits, clinical trial opportunities are discussed with patients, evaluated, and offered like other treatment options. Participation in studies is not seen as unusual or last-resort, but rather as a standard, accessible component of comprehensive lupus management.

It is important to recognize that the majority of patients learn about clinical trials from their healthcare provider. I work to integrate research discussions into the clinical encounter so that patients have the opportunity to participate in a clinical trial, should they be interested and eligible.

When clinical trials are embedded in routine care, participation becomes accessible, familiar, and patient-centered. This can really transform lupus care—broadening therapeutic options, improving outcomes, and accelerating the discoveries patients urgently need.

For patients, this means access to innovative therapies years before they are commercially available; more personalized care and a deeper understanding of their disease; greater empowerment and engagement; and more opportunities to participate in research.

For providers, it enhances the treatment option repertoire; improves disease understanding and monitoring; and offers closer collaboration with research teams and the patients they care for.

For lupus researchers, it speeds recruitment; offers more representative study populations; improves data quality; and accelerates the development of new therapies.

What are the biggest barriers to making lupus clinical trials part of daily care a reality, from both the patient and provider points of view?

Understanding patient and provider barriers may help explain why participation in clinical trials remains low despite strong interest in new treatments.

In my experience, these include patients’ lack of awareness of trial availability or their relevance beyond severe disease; considerations regarding trust, and concerns about safety, side effects, or placebo use; everyday challenges like fatigue, flares, work, travel, and childcare; stringent, often unrealistic study inclusion/exclusion criteria; limited outreach reflecting diverse languages and cultures; and distance from major centers that offer clinical trial opportunities.

From the provider perspective, time constraints, limited knowledge of available trials, and concerns about complicating care or burdening patients can hinder discussions about clinical trials. Many clinics also lack the infrastructure, like research coordinators and streamlined workflows, to integrate trials into routine visits.

In order for clinical research to become an equitable, accessible part of high-quality lupus care, we need to reduce logistical and trust barriers for patients and build supportive, streamlined systems for providers.

What strategies and tools are being applied to break down those barriers? How is Lupus Therapeutics/LuCIN helping?

LuCIN, overseen by Lupus Therapeutics, is the premier network of over 60 top lupus clinical trial centers across North America. LuCIN centralizes lupus expertise and infrastructure under one umbrella, simplifying access and coordination for patients and providers. This dedicated network helps ensure high-quality, standardized trials and reduces fragmentation between “care” and “research.” Having many sites distributed geographically also increases the likelihood that patients can more easily access trial centers.

The services offered by Lupus Therapeutics aim to reduce the administrative burden on sites and accelerate trial startup. Lupus Therapeutics and LuCIN have several working groups and initiatives that are focused on provider and patient education—improving clinical trial awareness, reducing mistrust, and expanding access, especially among historically underrepresented groups.

Peer-to-peer and community-based outreach help overcome misconceptions, build trust, and make trials more accessible and normal. In addition, Lupus Therapeutics and LuCIN foster collaboration among investigators and provide mentoring and training to new investigators. Finally, by integrating patient voices across the research continuum, study designs become more patient-centered, reducing unnecessary burden and improving reach and relevance.

At UNC, our experience has shown that making clinical trials part of day-to-day lupus care is both achievable and deeply beneficial for patients. The key has been weaving research into the fabric of our regular clinic workflow so that trials feel like a natural extension of the care we provide—not something separate or intimidating.

One of the most effective strategies has been normalizing trial conversations. I routinely review clinical trial options during visits, just as I discuss medications or monitoring plans. Patients quickly learn that clinical trials are simply another option, and this helps reduce stigma, fear, and implicit bias. Over time, patients start to ask us about studies, which suggests that we are shifting the culture. We hold regular interactive workshops and educational activities that foster this culture among our faculty and fellows (trainees).

Another essential piece has been embedding research staff directly into the clinic. Our research coordinators screen charts in advance, join us in the clinic, and can meet patients immediately when there is potential interest. This seamless handoff takes the pressure off clinicians, prevents missed opportunities, and reassures patients. Regular check-ins between the clinical and research teams keep us aligned, and transparent, patient-centered conversations make patients feel respected and informed.

Overall, integrating trials into daily care at UNC has shown us that patients are far more open to research when we meet them where they are, reduce logistical burdens, and treat clinical trial participation as an integral part of high-quality lupus care.

What are the considerations for both the patient and provider with an individual being treated with an investigational medicine versus an approved therapy?

When I talk with patients about investigational treatments versus approved therapies, I think about a few key considerations. Approved medications give us a clear sense of expected benefits and risks, and while every patient is unique, we know for the most part what to expect. Investigational medicines may provide promising options when current treatments fall short, but there is a level of uncertainty because we are still learning about their safety and effectiveness.

Some patients appreciate the closer monitoring that clinical trials offer, and the chance to contribute to research, while others find the logistics challenging. From the provider’s perspective, we must ensure therapy suitability, safe monitoring, continuity of care, and post‑trial planning.

Ultimately, the decision has to be individualized based on what’s best for each person. My role is to help patients understand the trade-offs clearly so we can choose the option that aligns with their goals, values, and day-to-day realities at that point in time.

How can people living with lupus learn more about how clinical trials may benefit them?

Understanding their options empowers patients to make informed decisions and consider clinical trials as part of their overall care. Patients can start by asking their provider about open studies, exploring reputable websites like ClinicalTrials.gov or the clinical trials matching tool on the Lupus Therapeutics website, and being strong advocates for themselves. To find a provider, you can visit theLupus Therapeutics Healthcare Provider Directory.

Our LuCIN network plays a key role by linking patients to experienced lupus centers and trials across North America. Talking with research coordinators, patient support groups, or engaging in community programs can help clarify what participation involves, the potential benefits, and any risks.

It is absolutely essential that our patients are active partners in their care, and it is a goal that I strive for every day.

By embedding clinical trials into standard of care, we redefine what’s possible—turning routine treatment into an opportunity for discovery, innovation, and better outcomes for people living with lupus. To learn about clinical trials that might be a potential fit for you, visit here.