Reversing the Trend: Making Clinical Trials More Diverse

GAP-Net site Kerwin Medical Center in Dallas and GAP President John Dwyer were featured in D Magazine talking about how the Bio-Hermes study is making it easier for diverse populations to participate in its new Alzheimer’s trial.

Dallas-based Kerwin Medical Center is emphasizing diversity as it enrolls patients in the Global Alzheimer’s Platform Foundation’s (GAP) Bio-Hermes study, which sets out to determine which biological marker test is most effective at foretelling the hallmark of Alzheimer’s. Unlike prior Alzheimer trials, the Bio-Hermes study seeks to improve racial diversity in trials by recruiting volunteers until 20% of the participants are Black or Hispanic.

Because of the hurdles to participating in and being aware of clinical trials, trial patients have historically been privileged and White. Nearly 14 percent of Americans are Black, yet they make up less than 5 percent of trial participants. Even though Latinos are 18 percent of the country, they represent just 1 percent of clinical trial patients

Dr. Diana R. Kerwin, the founder, and president of Kerwin Medical Center, says clinic trials have a long-standing history of neglecting African American and Hispanic populations. “If you’re going to test drugs, they need to work for everybody. White Europeans are only roughly 70% of the general population over 60 years old,” she says. “So when we conduct clinical trials, and they’re all white Europeans in the trial, we’re not getting a good picture on whether the drug works for everybody.”

Although there are medical technologies to determine whether someone has Alzheimer’s or not, it can be time-consuming with many visits to the doctor and a PET scan. But GAP President John Dwyer says he wants to expedite this process by developing a simple test to see signs of dementia. “We’re trying to get similar blood tests like those for heart disease or diabetes for Alzheimer’s, and this particular clinical trial that we’re undertaking is attempting to show where the new technologies are relative to the accepted, costly brain scans and show that they’re highly predictive and correlated and make it a lot easier to treat millions of people,” he said.

Blood plasma tests provide indications of where specific proteins are in the blood and their levels, which is correlated to whether or not you have the disease. Since African Americans show the presence of Alzheimer’s at lower levels of this blood marker, it makes it important to represent different populations in the study. Despite failures in the past to include minority populations in clinical studies, researchers showed it was possible with trials during the COVID-19 pandemic.

“People of color, particularly African Americans and Latinos, are more vulnerable to COVID and are dying at a higher rate than White European descent people were,” Dwyer says. “So when they did the trials for the vaccines, they made a very intentional, conscious amendment to make sure they had a lot of folks from those communities in their trials.”

To recruit volunteers from communities of color in their study, GAP will make access to trial participation easier for these groups by offering free transportation and paying stipends to participants. The organization has also recruited people of color and Spanish-speaking members on their research team to encourage participation and make the experience easier for underrepresented populations. Participants don’t need to be diagnosed with Alzheimer’s to join the study because the study focuses on tests that differentiate healthy people from unhealthy people.

“The important thing is that they seriously consider being part of the study and giving their precious time to us to make sure we get good results,” Dwyer says. “We need to make it easy for them. And they need to give us their time.”

Originally posted by D Magazine on July 7, 2021.