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Even though the 2018 US Census Bureau population estimates report that non-Hispanic white Americans represent 60.7% of the US population, non-Hispanic whites of European ancestry comprise more than 90% of the population in clinical trials.
This imbalance in clinical research inclusion leads to limitations in applying clinical data, therapeutic indexes, drug safety, and toxicity. Unsuccessful cancer therapies, as well as limitations in screenings owing to genetic variability, are other consequences.
Moreover, taking into account the financial consequences, LaVeist et al estimated that if the racial and ethnic health disparities gap had been closed during the 2003 to 2006 period, health care costs in the United States would have been decreased by $1.2 trillion.
The objective of this study was to determine the racial and ethnic minority representation in randomized clinical trials (RCTs) in the United States. Our original query on June 15, 2019, yielded 569,685 RCT publications, from which 254,535 (44.67%) were originating from the United States. A smaller proportion of 59,577 (23.41%) had NIH support, whereas the rest of the 194,958 (76.59%) were non–NIH-funded studies. The total percentage of minority inclusion from all RCTs published in the United States during the last 25 years was 3.95% (n=10,057); of those, 45.63% (n=4590) were from non–NIH-supported studies, and 54.36% (n=5467) were NIH-supported studies.
The NIH-funded studies had a 4-fold increase in minority inclusion (an increment from 2.78% to 11.10%), compared with non–NIH-funded RCT studies, in which the total increase was 2.2-fold (from 1.23% to 2.78%) during the same period (Table).
TableComparison of Ethnic/Racial Make-Up of Manuscripts Involving Minorities in 1993 and 2018
Regarding specific minorities from all data, we found that the highest increase in inclusion was in African Americans: from 0.97% to 2.23%. The Hispanic/Latino representation rose in second place, from 0.18% to 1.24%, and Asian Americans rose from 0.14% to 1.04%. Inclusiveness of minorities in the United States for NIH-funded studies outpaced those without NIH funding (Figure).
These results support our hypothesis that although the NIH Revitalization Act of 1993 has helped stimulate the inclusion of traditionally under-represented populations in NIH-funded studies compared with those without NIH support; racial and ethnic minorities are still vastly under-represented in biomedical research.
Our analysis shows that despite the NIH and its affiliated agencies’ best efforts to reduce the under-representation of minorities in RCTs, the current research environment is skewed toward studying the non-Hispanic white European population.
As a result, health care disparities are aggravated within under-represented populations. Although the NIH guidelines have contributed to an increase in minority inclusion, continued efforts should be met to decrease the gap of health disparities, as, in the end, those who benefit from the development of new therapeutic interventions and treatments depend largely on who is studied.
The more things change, the more they stay the same.