Data presented at an American Association for Cancer Research virtual conference in October revealing that Black patients were significantly more likely to be excluded from pancreatic clinical trials than white counterparts is unfortunately not the only instance of this occurring, says GlobalData. The data and analytics company notes that there is an ever-growing concern of ethnic disparity in clinical trials, as recently seen in COVID-19 research.
Alice Beckley, PhD, senior oncology and hematology analyst at GlobalData, explains: “Racial disparity exists way beyond oncology, and can be seen in many areas of healthcare management. For example, there was a disparity in COVID-19 research among the Black, Asian, and minority ethnic people. This contributed to devastating results: [Our] epidemiologists reported that patients with Black ethnicity had the highest death rate due to COVID-19, with 62 deaths per 100,000 Black population reported in the U.S. and 41 deaths per 100,000 Black population reported in the [United Kingdom]. Such examples highlight the need for improved clinical trial recruitment and the pressing issue of regurgitating historic eligibility criteria that have no clear scientific or clinical rationale.”
Race and ethnicity are taken into account in clinical trials because these aspects do contribute to interindividual differences to drug exposure and response. The risk-benefit ratio is, therefore, altered in specific populations. However, inadequate clinical trial representations of all populations can leave excluded patients vulnerable, as there will be a limited risk-benefit assessment in these subgroups.
Beckley continues: “As an example, according to the 2018 national vital statistics report, African Americans were 30% more likely to die from heart disease than non-Hispanic whites in cardiology. Although it has been generally reported that heart conditions disproportionately affect Black patients, due to a higher prevalence of risk factors in that group, it is yet to be appropriately recognized during clinical trial recruitment. The [U.S. Food and Drug Administration’s] global participation in clinical trials report found that African Americans only accounted for 2.5% of cardiology clinical trial participants.”
Improving diversity in clinical trials ensures that healthcare delivery and public health strategies are appropriately tailored to all populations, as well as maximize the generalizability of trial results and increase clinical knowledge on disease pathophysiology and the range of genetic profiling, Beckley concludes.
Edited by Gary Cramer