Black Patients Still Underrepresented In Clinical Trials Despite FDA Action Plan

In 2015, the U.S. Food and Drug Administration launched a five-year action plan, aiming to improve diversity in clinical trials for newly approved drugs.

According to HealthDay, Angela K. Green, M.D., from the Memorial Sloan Kettering Cancer Center in New York City, and colleagues analyzed Snapshots data to examine whether the initiative had led to an improvement in the inclusion of Black patients in clinical trials.

The report published in the March issue of Health Affairs determined Black patients remained inadequately represented in clinical trials for drugs.

Research shows that Black Americans, who make up roughly 14 percent of the U.S. population, account for only 3.1 percent of participants in clinical trials for cancer drugs — meaning Black enrollees are represented at only 22 percent of the expected level.

There are many barriers to the participation of racially and ethnically underrepresented patients in clinical trials include: (1) mistrust, (2) fear, (3) lack of comfort with the clinical trial process, (4) lack of information about clinical trials, (5) logistical constraints associated with participation such as time and out-of-pocket expenses, and (6) the impacts of social determinants of health. In addition, there is a shortage of suitably qualified investigators and a lack of infrastructure & resources needed to perform clinical trials in underrepresented communities and populations, according to The National Health Council.

Efforts to increase diversity must begin long before a trial gets underway, that is, with the design of the study itself, according to research leaders.

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