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In a novel study design, MHRI researchers found that biases in screening may account for disparities in clinical trial enrollment and recommend ways to improve participation diversity and accessibility.
In Washington, D.C., 46.3% of people are Black and 10.7% are Hispanic—just 39.4% of the population are white. Across the U.S., Black adults are more than twice as likely as white peers to die of heart disease.
Yet Black and Hispanic patients are significantly underrepresented in cardiovascular clinical trials.
MedStar Health Research Institute scientists turned a sharp view to our patient data in pursuit of improvement. We designed a first-of-its-kind research study that revealed barriers early in the clinical trial screening process. This revelation will help us improve clinical trial equity here and at health systems across the U.S.
Understanding disparities in cardiovascular clinical trials.
Our first step was to analyze data from 4,298 patients who had cardiovascular procedures. Of these patients, 42.5% were white, 46.1% were Black, and 3.9% were Hispanic. We screened 684 patients for clinical trials and enrolled 363 of them.
The data clearly showed that cardiovascular clinical trial enrollment is not reflective of our patient population:
- More Caucasians were screened (66.4%) and enrolled (63.1%).
- Just 29.7% of Black patients were screened, and 33.9% were enrolled.
- Among Hispanic patients, 1.3% were screened, and 1.4% were enrolled.
Screening log data.
Next, we analyzed screening logs from these cardiovascular clinical trials, including data on patient race, ethnicity, study type, and why a patient did not qualify.
We were pleased to learn that medical criteria were the leading cause for disqualification for enrollment among racial groups—79.4% of Caucasian and 73.8% of Black patients. It is possible, for example, for a specific condition to affect the effectiveness of a medication or device.
However, we found racial disparities in clinical coordinators’ opinions about whether patients would follow clinical trial instructions and complete follow-up visits. There were 17.7% more Black patients excluded for this reason as compared with 8.3% of Caucasians.
This evidence of unconscious bias among research teams illuminates opportunities to help make clinical trials more equitable.
How can disparities in trials be reduced?
This research has identified an opportunity to educate providers about potential unconscious biases in screening that could lead to disparities. We have presented our data to the U.S. Food and Drug Administration with the following recommendations for overcoming barriers to trial enrollment:
- Create implicit bias training for providers, researchers, and clinical trial screeners and coordinators
- Reach out to the community to raise awareness about clinical trials
- Provide patient resources such as transportation, education, and patient advocates
- Ensure informed consent forms and follow-up information are available in a variety of languages
Our data also emphasize the need to design clinical trials to include diversity, with less restrictive criteria, so that more patients can participate.
We are implementing these recommendations at MedStar Health and tracking their impact on helping more patients access trials. Once our methods are standardized, we plan to expand them to specialties beyond cardiology and share them with systems across the U.S.
As a leading research institution, we aim to eliminate disparities and improve research equity. It is not just good science but also a commitment to our community.