An Insider's Look Into Clinical Trials at BRI

Before medicines become widely available, they have to be rigorously tested — first in the lab, then in people through clinical trials.

“That’s how we got every medicine in the cabinet. Tylenol, aspirin, antihistamines all had to go through rigorous trials to make sure they were safe and effective,” says Sandra Lord, MD, clinical director of BRI’s Center for Interventional Immunology (CII) and director of BRI’s Clinical Research Center.

Sandra Lord, MD

Clinical trials are key to realizing BRI’s vision of a healthy immune system for everyone. Scientists in our CII lead and run clinical trials aiming to predict, prevent, reverse and cure immune system diseases. Through our Clinical Research Program (CRP), BRI also conducts clinical research across a wide spectrum of diseases including digestive diseases, heart disease, neurologic conditions, and cancer in partnership with Virginia Mason Medical Center (VMMC). This work includes testing new medicines, devices and clinical procedures.

“Clinical trials are crucial to getting new innovative treatments and life-saving medicines to people who need them,” Dr. Lord says. “For example, BRI was a site for Pfizer’s COVID-19 vaccine trial and many BRI and VMMC employees were volunteers for that study. That’s the kind of thing you look back on in 40 years and tell your grandkids about.”

Building and Leading Immunology Trials Through the CII

Dr. Lord started out as a primary care physician and never planned to work in research. Then she learned about an opening on BRI’s diabetes clinical research team. Having lived with type 1 diabetes (T1D) for most of her life, she jumped at the opportunity to help predict, prevent, reverse and cure T1D.

An early project she worked on was teplizumab — an immune therapy aimed at delaying or even preventing T1D. BRI conducted some of the research that laid the groundwork for this drug.

“The final results brought tears to my eyes: The medicine could delay T1D for a median of two years,” Dr. Lord says. “That’s a day we’ll never forget because it showed for the first time that everything we’ve been working toward is possible, that we can change the course of autoimmune diseases before they start.”

BRI’s Diabetes Research Program has grown into the CII and now runs clinical trials for other autoimmune diseases. Here are two noteworthy trials underway.

Exploring Viruses and Immune System Diseases

BRI’s Carmen Mikacenic, MD, and Matt Altman, MD, MPhil, are exploring whether immune system disorders such as rheumatoid arthritis (RA), asthma or allergies affect how the immune system responds to viruses like the common cold or COVID-19. They are studying blood, saliva and nasal samples from adults with RA, children with asthma and allergies, and people with no immune system diseases. Their goal is to better understand if and how viruses impact RA, asthma and allergies and find ways to improve care for these conditions.

Can IBD Medicines Slow T1D?

Several medicines can slow the immune system’s attack on the gut in people with inflammatory bowel disease (IBD). The CII team is looking at whether those same medicines might also help with T1D by slowing attacks on the pancreas. This trial is testing a medicine called vedolizumab and a combination of vedolizumab and another medicine, etanercept, to see if it can slow the progress of T1D.

Clinical Trials

A clinical trial tests an intervention, such as a new drug, a new device, or a behavior change, over a period of time. It often will have a comparison group that does not receive the intervention.

Biorepositories

BRI’s biorepositories are robust libraries of blood and tissue samples from people with and without immune system diseases. We study these samples in the lab to better understand how and why diseases happen and to find new treatments and prevention.

Clinical Studies

A clinical study is a broad term for research that aims to better understand human health and disease. It may be interventional (where a drug, device or behavioral change is tested) or observational (where information is collected, analyzed and described, but no intervention is given).

Trials in Partnership with VMMC

While the CII runs trials building on BRI’s lab discoveries and focusing on immune system diseases, the Clinical Research Program (CRP) and VMMC carry out trials of new therapies for many different diseases.
“We run these trials from A to Z, generating crucial data and giving VMMC patients options. Conducting trials can also lead to early access to cutting-edge technologies,” says Cecilia Morgan, PhD, CRP director.

Two significant trials that the CRP and VMMC have participated in recently include:

Device to Treat Brain Tumors

Treating brain tumors can be especially difficult because doctors need to use enough radiation to take out cancer cells but not so much that it significantly damages healthy brain tissue. A new device called GammaTile aims to deliver more targeted radiation treatment to people who have cancerous brain tumors. After surgically removing the tumor, doctors install this tiny device where the brain tumor was so it can deliver radiation to a very specific area. The GammaTile proved highly effective at targeting cancer cells and causing less harm to healthy brain tissue. Through participation in clinical trials, the Virginia Mason Medical Center was among the first institutions nationwide and first in Washington state to be able to offer this treatment.

Screening and Treatment to Prevent Anal Cancer

People with anal cancer often don’t experience symptoms until the cancer is in the later stages and more difficult to treat. This study examined whether early screenings and preventive treatment could improve anal cancer outcomes for people with HIV, who have a higher risk of developing this cancer. This trial offered routine anal cancer screenings for people with HIV. If they found a precancerous change in the tissue, they targeted the area with an electrical pulse to see if it could stop cancer from developing.

“The treatment resoundingly lowered the incidences of anal cancer — so much so that they actually stopped the study early so they could provide it to people in the non-treatment group,” Dr. Morgan says. “Making this screening and treatment standard of care for groups at higher risk will save lives.”

Learn more and get involved with BRI’s clinical research.