CHICAGO — Clinical trials are so White. Only a small percentage of eligible patients participate in clinical trials in the first place, and very few come from racial and ethnic minority groups.
For example, according to the US Food and Drug Administration, in trials that resulted in drug approvals from 2017–2020, only 2 to 5% of participants were Black patients.
When clinical trials lack diverse patient populations, those who are left out have fewer opportunities to get new therapies. Moreover, the scope of the research is limited by smaller phenotypic and genotypic samples, and the trial results are applicable only to more homogeneous patient groups.
There has been a push to include more underrepresented patients in clinical trials. One group reported its success in doing so here at the American Society of Clinical Oncology (ASCO) 2023 annual meeting.
Researchers from the Alliance for Clinical Trials in Oncology explained how a multifaceted approach resulted in a 75% relative improvement in trial enrollment from 2014–2022, a period that included a pandemic-induced hiatus in clinical trials in general.
Dr Electra Paskett
Alliance member Electra D. Paskett, PhD, from the College of Public Health at the Ohio State University in Columbus, presented accrual data from 117 trials led by the Alliance from 2014–2022.
During this period, accrual of racial and ethnic minority patients increased from 13.6% to 25.3% for cancer treatment trials and from 13% to 21.5% for cancer control trials.
Overall, the recruitment program resulted in an absolute increase from 13.5 % to 23.6% of underrepresented populations, which translated into a relative 74.8% improvement.
“We’re focusing now on monitoring accrual of women, rural populations, younger AYAs [adolescents and young adults] and older patients, and we’ll see what strategies we need to implement,” Packett told Medscape.
The Alliance has implemented a real-time accrual dashboard on its website that allows individual sites to review accrual by trial and overall for all of the identified underrepresented populations, she noted.
Program to Increase Underrepresented Patient Accrual
The impetus for the program to increase enrollment of underrepresented patients came from the goal set by Monica M. Bertagnolli, MD, group chair of the Alliance from 2011–2022 and currently the director of the US National Cancer Institute.
“Our leader, Dr Bertagnolli, set out a group-wide goal for accrual of underrepresented minorities to our trials of 20%, and that gave us permission to implement a whole host of new strategies,” said Paskett in an interview with Medscape Medical News.
“These strategies follow the Accrual of Clinical Trials framework, which essentially says that the interaction between the patient and the provider for going on a clinical trial is not just an interaction between the patient and provider but recognizes, for example, that the provider has co-workers and they have norms and beliefs and attitudes, and the patient comes from a family with their own values. And then there are system-level barriers, and there are community barriers that all relate to this interaction about going on a trial,” Packett said.
The study was presented as a poster at the meeting. During the poster discussion session, co-moderator Victoria S. Blinder, MD, from Memorial Sloan Kettering Cancer Center in New York City, asked Paskett, “If you had a certain amount of money and you really wanted to use that resource to focus on one area, where would you put that resource?”
“I’m going to violate the rules of your question,” Paskett replied.
“You cannot change this problem by focusing on one thing, and that’s what we showed in our Alliance poster, and what I’ve said is based on over 30 years of work in this area,” she said.
She cited what she considered as the two most important components for improving accrual of underrepresented populations: a commitment by leadership to a recruitment goal, and the development of protocols with specific accrual goals for minority populations.
Still, those are only two components of a comprehensive program that includes the aforementioned accrual goal set by Bertagnolli, as well as the following:
Funding of minority junior investigators and research that focuses on issues of concern to underrepresented populations
Establishment of work groups that focus on specific populations with the Alliance health disparities committee
Translation of informational materials for patients
Opening studies at National Cancer Institute Community Oncology Research Program–designated minority underserved sites
Real-time monitoring of accrual demographics by the Alliance and at the trial site
Closing protocol enrollment to majority populations
Increasing the study sample sizes to enroll additional minority participants and to allow for subgroup analyses
The study was funded by the National Institutes of Health. Packett and Blinder reported no relevant financial relationships.
American Society of Clinical Oncology (ASCO) 2023: Abstract 6509. Presented June 3, 2023.
Neil Osterweil, an award-winning medical journalist, is a long-standing and frequent contributor to Medscape.
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