BIDMC’s study is the first of its kind to look at investigators’ planning documents for various research participant populations, and it found significant disparities in the representation and recruitment of Black Americans in federally sponsored cardiovascular disease trials.
Researchers from Beth Israel Deaconess Medical Centre (BIDMC) reviewed federally funded cardiovascular disease trials from 2000 to 2019 in a newspaper published in the Journal of the American Heart Association to see if different recruitment strategies affected the number of Black participants enrolled.
Efforts To Recruit Black Adults Into Cardiovascular Disease Clinical Trials Are Futile
The facts revealed by the research have surprised many experts as the clinical trials are not that favorable for blacks irrespective of their age and other parameters.
Cardiovascular illness affects black adults disproportionately; however, they are overlooked in cardiovascular disease clinical research studies in the United States.
Researchers from Beth Israel Deaconess Medical Centre (BIDMC) reviewed federally funded cardiovascular disease trials from 2000 to 2019 in a new paper published in the Journal of the American Heart Association to see if different recruitment strategies affected the number of Black participants enrolled
According to the National Institutes of Health (NIH), investigations should establish targets for recruiting underrepresented clinical trial participants.
While the researchers discovered a connection between identifying recruitment targets for underrepresented populations and increased Black participant enrolment, the majority of trials either did not specify a Black enrolment target or did not fulfill it.
Finally, the researchers discovered that Black people remain to be underrepresented in cardiovascular disease trials and that enrolment rates have not improved over time.
Few other studies also have examined whether modern recruitment strategies, such as electronic medical record-based recruitment, are useful tools for enrolling Black individuals, and no overview of the usage of these methods in cardiovascular clinical trials has been performed to date.
In cardiovascular disease studies, black individuals are still severely underrepresented, and enrolment rates have not improved over time.
“Increasing the enrolment of Black participants in clinical trials is critical to ensure that the scientific literature guiding clinical practice better reflects the diversity of individuals in the United States,” said corresponding author Stephen Juraschek, MD, Ph.D., a clinician-researcher (HMS).
Juraschek and colleagues including first author Anagha Prasanna of HMS analyzed 100 federally-funded cardiovascular interventional clinical trials to see if specifying a minority recruitment target or using specific recruitment strategies were associated with a higher proportion of Black enrollees.
The researchers discovered that of the 100 NIH-funded trials that fulfilled their criteria, 62 had recruiting protocols (precise, step-by-step experimental methodologies defined during the design of a trial prior to its implementation) available.
Only about half of the studies reported enrolling fewer than 25% Black participants, and nearly a quarter of the trials did not specify what percentage of enrollees identified as Black.
Cardiovascular disease accounts for about 25% of all deaths among Black adults, but only about half of the studies reported enrolling fewer than 25% Black participants.
Only one study reached its aim for enrolling Black participants, despite the fact that 21% of studies expressly indicated target goals for recruitment of historically underrepresented communities.
Perhaps most troubling, Juraschek and colleagues discovered no significant changes in the recruitment of Black people between 2002 and2017, nor in the number of studies with enrolment targets.
Selection is a key aspect of a trial’s success, and it’s best done during the design and protocol development phases to ensure a varied and representative participant pool.
More work has to be done at the institutional and national levels to define standards that include recruitment strategies and targets for underrepresented groups. Discrimination should not be tolerated.