IBD trials underrepresent racial and ethnic minority groups
Click Here to Manage Email Alerts
LAS VEGAS — Inflammatory bowel disease clinical trials underrepresent racial and ethnic minority groups, according to a presentation at the ACG Annual Scientific Meeting.
“Enrollment rates in IBD clinical trials are low for all patient groups. The underrepresentation of racial and ethnic minority groups in IBD clinical trials revealed by our analysis are highly relevant to the rapidly changing demographics in the United States,” Jellyana Peraza, MD, of the department of medicine at the Albert Einstein College of Medicine at Montefiore Medical Center, said during the presentation.
“Future studies should focus on understanding and addressing contributing factors and ensure broad access to trials for underrepresented populations,” Peraza said.
IBD trials lack in diversity
Peraza and colleagues identified 132 clinical trials with patients with ulcerative colitis or Crohn’s disease, performed from 2000 to 2020 and registered at ClinicalTrials.gov. Of these, 78 reported on the patients’ race or ethnicity. There were 56 international trials and 22 were performed in only the United States, Peraza noted.
Enrollment fraction was defined as the number of clinical trial enrollees divided by the average U.S. prevalence of IBD obtained from the 1999 and 2015 National Health Interview Survey.
Correlations between race, ethnicity and enrollment in clinical trials were determined with logistic regression analysis.
In the United States, Peraza said the IBD research participation in the clinical trials varied between race and ethnic groups and over time. The enrollment fraction was lower in Black patients (OR = 0.82; 95% CI, 0.7-0.97; P = .02) and Native American patients (OR = 0.36; 95% CI, 0.18-0.72; P = .004) compared with white patients. However, enrollment fraction was significantly higher in Asian patients.
Among Hispanic patients compared with non-Hispanic patients, investigators noted a trend toward a lower enrollment fraction (OR = 0.81; 95% CI, 0.65-1.01; P = .06).
During the Q&A session after the presentation, Peraza noted a solution to the issue of underrepresentation of minorities is to assess different levels, such as institutional levels and patient levels. She said health care provider and industry bias may be barriers causing underrepresentation.
“If we can attack different levels, the participation of underrepresented populations would definitely increase,” Peraza said.
Solutions for underrepresented minorities
In a commentary published in Gastroenterology, Nathaniel A. Cohen, MD, from the Medicine Inflammatory Bowel Disease Center, University of Chicago, and colleagues identified 641 publications that included 24,315 patients in IBD trials. There were 32 trials that included race demographics and 10 included ethnicity demographics. Of these trials, only 12 mentioned the percentage of white participants and 20 reported increased breakdown of race demographics, including a combination of white, black, Asian, Native Hawaiian or Pacific Islander, Native American, Hispanic and other.
“We have described a significant racial disparity and a very low proportion of racial minorities in phase 2 and 3 clinical trials of therapies for IBD and limited reporting of ethnicity data,” Cohen and colleagues wrote. “These disparities are likely due to multiple factors, and we propose that
greater effort be made at multiple levels for the appropriate participation of all racial and ethnic groups in clinical trials.”
The researchers proposed solutions to increase racial and ethnic representation in IBD
clinical trials, including:
- Studies should be designed with sufficient power to assess efficacy and safety in underrepresented groups.
- Recruitment strategies should be developed to enroll underrepresented groups and address hesitancy in trials.
- There should be standardized requirements for reporting of race and ethnicity data across clinical trials. Also, a description of methods used to figure out race/ethnicity should be included.
- Minoritized groups should be included in a priori subset interpretation of clinical trial data.
- There should be clear communication and follow-up of therapies in underrepresented groups in post-marketing studies.
- There should be studies investigating and reporting disparities of care in IBD and racial inequalities in health outcomes.
Editor’s Note: On Nov. 2, 2021, we updated the article to include additional research recently published.
Collapse
Peraza J, et al. Abstract: S701. Presented at: ACG Annual Scientific Meeting; Oct. 22-27, 2021; Las Vegas (hybrid meeting).
Cohen NA, et al. Gastroenterology. 2021;doi:10.1053/j.gastro.2021.09.035.
Click Here to Manage Email Alerts