Cardiovascular Disease Clinical Trials Still Lack Diversity

Black Americans are still significantly underrepresented in cardiovascular disease clinical trials, and enrollment rates have not improved over time, according to a new paper published in the Journal of American Heart Association. 

Researchers from Beth Israel Deaconess Medical Center (BIDMC) reviewed federally funded cardiovascular disease trials run between 2000 and 2019 to determine whether various recruitment strategies impacted the number of Black participants enrolled.

The team examined each trial’s recruitment strategies, including active and passive recruitment, community-based recruitment, electronic medical record-based recruitment, and healthcare provider referrals.

They found that 62 out of 100 NIH-funded trials included protocols outlining recruitment efforts available. And among the 90 percent of trials that reported active recruitment strategies, five percent of trial protocols mentioned community members as part of the trial design process. 

Additionally, half of the studied trials enrolled fewer than 25 percent Black participants, and a quarter of the trials did not specify what percentages of enrollees identified as Black.

Trials that did not define recruitment strategies had an inadequate representation of Black participants. And while 21 percent of studies mentioned target goals for recruitment of underrepresented populations, just one met its trial goal for enrolling Black participants. 

The most notable study finding, according to researchers, was no substantial change in the recruitment of Black Americans or the number of trials defining recruitment between 2002 and 2017. 

“There’s a critical need to increase the enrollment of Black participants in clinical trials to ensure that the scientific literature guiding clinical practice better reflects the diversity of individuals in the United States,” wrote Stephen Juraschek, MD, PhD, a clinician researcher in the division of general medicine and primary care at BIDMC and assistant professor of medicine at Harvard Medical School.

“Investigators play a critical role during the study design phase by defining recruitment goals and formulating recruitment strategy to meet those goals,” Juraschek continued. 

The BIDMC research was the first to examine diverse research participant populations and critical gaps in the representation and recruitment of Black Americans in federally-funded cardiovascular disease trials. 

Overall, the team found a link between defining recruitment targets for underrepresented populations and higher enrollment of Black participants. But the majority of trials did not specify a Black enrollment target or did not meet such targets. 

Anagha Prasanna of Harvard Medical School voiced that more work must be done to standardize protocols to include recruitment strategies and recruitment goals for underrepresented groups both at the institutional and national level.