Session to Address Health Disparities and Other Challenges to Clinical Trial Design

The session Meet the Panel: How Can We Rescue Clinical Trials? on Monday, Nov. 18, from 10:30–11:30 ET in Room 145AB at the Walter E. Washington Convention Center, will address a broad range of topics about clinical trials, including challenges and areas of improvement. One of the important shortcomings that will be addressed is health disparities in clinical studies, in particular challenges with engagement and enrollment, especially for underrepresented individuals living with lupus.

Speakers include: Saira Sheikh, MD, the Linda Coley Sewell Distinguished Professor of Medicine in the Division of Rheumatology, Allergy and Immunology at the University of North Carolina at Chapel Hill (UNC), and Director of Clinical Trials at UNC’s Thurston Arthritis Research Center; Glen Hazlewood, MD, PhD, FRCPC, Associate Professor of Medicine, University of Calgary, Canada; Karen Costenbader, MD, MPH, the Michael Weinblatt, MD Distinguished Chair of Rheumatology and Director of the Lupus Program at Brigham and Women’s Hospital, and Professor of Medicine at Harvard Medical School; and Janet Pope, MD, FRCPC, MPH, Professor of Medicine in the Division of Rheumatology at the University of Western Ontario, Schulich School of Medicine, Canada.

The session will be available on-demand to all registered ACR Convergence 2024 participants after the meeting through Oct. 10, 2025, by logging into the meeting website.

“This is an exciting time for drug development in rheumatologic and immune-based diseases, such as systemic lupus erythematosus (SLE), with so many novel therapeutic options and mechanisms on the horizon that are being evaluated in clinical trials,” Dr. Sheikh said. “However, enrollment of participants into clinical trials remains a challenge, particularly ensuring adequate representation of diverse groups, mainly racial and ethnic minoritized populations.”

Studies have shown that in lupus trials, the main reason why people from historically marginalized communities haven’t participated is that no one asked them, noted Dr. Pope. This remains a significant challenge for these populations, which may be largely affected by a particular disease but aren’t included in the associated clinical trials.

Another important issue that will be discussed is conducting well-designed clinical trials that improve access and opportunities for patients. This involves assessing how to improve diversity, equity, and inclusion (DEI) in clinical trials. Investigators must ask how they can look at DEI to ensure that the population being researched will have access to any resulting treatments, Dr. Pope said.

Unnecessary exclusion criteria can prevent certain people from being included or approached to participate in clinical trials and hinders enrollment. According to Dr. Pope, having too many exclusion criteria, especially for a drug that has been approved for another disease, doesn’t always protect the patient’s safety and can make it harder to enroll patients and prevent researchers and trainees from doing research.

“I think, then, that we have to demand that the sponsors change some of the ways that we have inclusion and exclusion criteria,” Dr. Pope said. “We can help consult with them as the people doing the trials, but I think that a mindset has to change. What worked in 1995, and even in 2015, might not work in 2025.”

The session is also designed to highlight the role of patients as active partners in clinical research.

“On a personal and professional level, I am excited about effectively incorporating the patient voice and patient experience into clinical trials and working together to bring knowledge and opportunities for clinical trial participation to our patients who need them the most,” Dr. Sheikh said. “I also think it’s vital to create a culture where we can incorporate conversations about clinical trials into the day-to-day care of our patients, and address patient-specific and provider-specific barriers to enrolling diverse populations into clinical trials.”

Dr. Sheikh said she wants the audience to feel empowered by the session.

“I hope the audience will walk away knowing and feeling that we all have a role to play in ensuring that the patients we care for have access and opportunity to participate in clinical trials, should they choose to do so,” she said.