Though Black patients are “well-represented” in nephrology trials in the USA, Asian patients are insufficiently represented in both US and international studies. That is the conclusion of a new study published in the Journal of the American Society of Nephrology (JASN). Its authors, led by Qandeel Soomro (NYU Langone Health, New York, USA), argue that under-representation risks “worsen[ing] disparities” in health outcomes between ethnic groups.
Making the claim that there has not been sufficient description previously of reporting and enrolment practices in randomised clinical trials (RCTs), particularly in regard to racial and ethnic minorities, Soomro et al set out to compile data from PubMed that would provide greater clarity. In their analysis, the authors retrieved data from “ten high-impact journals” for the period 2000–2021 from PubMed. Pilot trials and those with fewer than 50 participants were not included, while the outcomes of interest were designated as the proportion of trials reporting race and ethnicity as well as of number of participants enrolled “in each race and ethnicity category”.
In total, data from 380 trials were included from across the world. Soomro et al found that “just over half” reported race, while only 12% reported ethnicity. Though “most enrolled participants were White,” they note, “Black individuals accounted for ≤10% of participants except in dialysis trials where they accounted for 26% of subjects.” They also point out that Black patients’ enrolment rates were high “relative to disease population prevalence” in trials taking place in the USA that related to chronic kidney disease (CKD), dialysis and kidney transplantation.
There, they represented 19% for acute kidney injury (AKI) trials, 26% for CKD, 44% for glomerulonephritis, 40% for dialysis and 26% for transplantation trials. Hispanic patients, meanwhile, represented 13% of participants in US dialysis trials—though they make up 29% of the US dialysis population. The authors go on to describe global under-representation of Asian patients in nephrology trials, adding that there is “marked underrepresentation in US CKD, dialysis and transplants trials”.
Though they make the case that “Black and Hispanic patients are well-represented” in nephrology trials, Soomro and colleagues argue in reviewing the findings: “More complete recording of race and ethnicity in nephrology trials is needed […] Asian patients are poorly represented in kidney trials both globally and in the USA.”
Speaking on the study to Renal Interventions, Soomro stated: “Our systematic review highlights the crucial need for comprehensive reporting of the demographics of the study population and transparent enrolment processes. This is essential to translate the findings of the trial into clinical practice. All stakeholders must make concerted efforts to ensure reporting standards are met and the study population reflects the disease and population prevalence.”