One barrier to enrolling minorities in research involves resources. For some studies, such as pediatric oncology clinical trials, there might not be enough resources to enroll one or two patients at a single site.
The Children’s Oncology Group, which represents more than 200 institutions worldwide, has helped create solutions to this problem. The group enrolls thousands of children, adolescents, and young adults in a single trial at a variety of sites.1
“The significance of this program is that historically, if you look back before the program was established, the number of enrollment, individually, was very low,” says Nupur Mittal, MD, assistant professor of pediatrics at Rush University Medical Center (RUMC) in Chicago. “The population we see are a majority — 60 to 70% — African American,” Mittal says.
The University of Illinois at Chicago (UIC) and RUMC had pediatric oncology research programs, but there were fewer than 10 clinical trials open, she says.
“If the number of patients is less, then you can’t justify the resources and open that many trials,” Mittal says. “Not all the patients would get access to clinical trials for different disease types and conditions, relative to a cancer diagnosis.”
Create a Collaboration
The solution to improve access to clinical trials to more patients, including underrepresented minority patients, was to form a collaboration.
RUMC, UIC, and the John H. Stroger, Jr. Hospital of Cook County formed a collaboration. They relied on the National Cancer Institutes’ IRB of record. They developed inter-IRB agreements that allow the three institutions to expedite enrollment in pediatric oncology trials, Mittal explains.
“We share resources and infrastructure, and some portion of the program is funded by a foundation,” she adds. “It’s too much work to activate a trial for one or two patients; it takes a lot of resources. Now, because of the fact that there are three institutions and there could be 10 patients, it has increased the volume of patients on the trial, and it has put more resources at our disposal. We now have research staff and infrastructure to activate the trials.”
The tri-institutional Children’s Oncology Group program saw total studies open to enrollment increase by 100%. Enrollment of ethnic minorities rose by 533%. Enrollment of Hispanic patients increased by 925%.1
The goal is to improve access and outcomes for children with cancer, Mittal says.
From the IRB’s perspective, there is an arrangement in which the central IRB approves all clinical trials. Each institution’s IRB also approves the clinical trial before activation. The entire process is expedited because of the IRB agreements, Mittal explains.
“When a patient walks in and there is a clinical trial that is not active at Rush, we can get it activated within days because the agreements are already in place,” she says. “Forming that collaborative IRB was an important first step. Then, we share clinical research resources and nursing staff. In the pediatric world of medium-sized community hospitals, one of the overarching problems is resources, whether it’s physician time, IRB stuff, or all of those resources that go into successfully running of a clinical trial,” Mittal says.
The collaboration has led to physicians working together in enrolling patients in trials, a type of cooperation that is challenging in places that have not developed such a collaboration. Since forming the collaboration, the number of open trials increased from about 10 to 45, she adds.
The collaboration and inter-IRB agreement took about a year to form, Mittal says.
“This has not happened overnight,” she adds. “It’s really important that the physicians and clinical research staff work together to make sure patients are given access to any available clinical trial.”
- Mittal N. Davidson J. Martinez MF, et al. A tri-institutional approach to address disparities in Children’s Oncology Group clinical trial accrual for adolescents and young adults and underrepresented minorities. J Adolesc Young Adult Oncol 2019;8:227-235.