Postbac Finds Underrepresentation in Clinical Trials
American Indian and Alaska Natives (AI/AN) make up only about 1 percent of participants in NIH clinical research studies, according to an analysis completed by NINDS’s Deionna Vigil.
“The number establishes a comprehensive profile of AI/AN enrollment so we can figure out how to make research accessible to Native communities in the U.S.,” said Vigil, a postbaccalaureate researcher at NINDS.
She got the idea to conduct the study 2 years ago when she was a participant in the institute’s Summer Internship Program. She learned of the program from friends while at a conference sponsored by the Society for Advancement of Chicanos/Hispanics and Native Americans in Science.
She interned under Dr. Barbara Karp, who was then chair of the NIH combined neuroscience institutional review board. The IRB provides ethical and regulatory oversight of research that involves human subjects and ensures compliance with regulations, including assuring appropriate representation of minorities in NIH studies.
That summer, Vigil sat in on meetings and reviewed protocols. She noticed that each protocol had a summary featuring demographic information. Typically, she’d find only 1 or 2 AI/AN participants in a study.
“I wasn’t sure if that was a theme NIH-wide or if it was just in the protocols our one IRB saw,” she explained. “I was interested in looking at why those numbers looked that way and what could be done to address it.”
The next summer, she came back to NIH and initiated a project to determine how many AI/AN participants were enrolled in NIH clinical research studies. Once she had an exact number, she could then try to figure out why so few members of this group enroll and what could be done to increase their opportunity to participate.
Vigil asked the Office of Protocol Services for enrollment information from intramural clinical research studies data covering 2014 and 2017. The results confirmed what she suspected.
“Natives know they are underrepresented. When we read scientific papers, we see other racial groups represented, but where are we?” she said. “Because we’re not included in these studies, other people don’t know what diseases affect us and at what rate.”
She found that many AI/AN participants enroll in trials on their own initiative, especially studies that are not focused on AI/AN health needs or their communities. One reason for low enrollment in clinical research studies is because physicians who primarily treat AI/AN populations were not aware of study availability, she explained. Right now, there is no way to appropriately make them aware of the studies.
Vigil created a survey for NIH investigators who had enrolled AI/ANs in their protocols and asked whether they were aware of AI/AN enrollment and if they did anything special to enroll them. She also asked about their awareness of biospecimen and data collection and sharing issues specific to AI/AN populations.
Next, she will use her data to support creation of a liaison between intramural researchers at NIH and tribal nations, as currently exists for extramural investigators. Right now, there are no clear processes on how to identify or handle AI/AN-specific issues that may arise when an individual AI/AN enrolls in an intramural clinical trial.
“The goal is to ensure AI/AN ethical inclusion while making our protocols accessible to them,” Vigil concluded.