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Studies published in leading medical journals continue to underreport information on participants’ race, and non-White individuals continue to be underrepresented in clinical trials, a new study published in JAMA Network Open shows.
Mikhaila Alegria, BScN, and colleagues analyzed all randomized clinical trials published in JAMA, The Lancet, and The New England Journal of Medicine in 2015 and 2019. They found that in both years, valium sleepiness approximately half of the studies reported participants’ race, 15% reported their socioeconomic status, and 98% reported their sex.
Although the reporting of racial demographic characteristics has improved since 1999, when just over a quarter of studies reported it, there was no change in this percentage between 2015 and 2019, “despite increasing attention to the importance of racial equity in medicine,” write Alegria, from the Hospital for Sick Children in Toronto, Ontario, Canada, and colleagues.
Among the studies that did report racial demographics, White individuals represented a median of 84% of the participants in 2015 and 77% in 2019, according to Alegria and colleauges. Female participants accounted for a median of 44% of participants in 2015 and 46% in 2019.
“Race, socioeconomic status (SES) and sex are fundamental determinants of health,” the authors write. The underreporting of race and the underrepresentation of minorities in clinical trials, they note, need to be addressed by medical journals, “given the recent acknowledgements of systemic racism in clinical medicine and research.”
Medical researchers must do their part to reduce these gaps, the researchers emphasize. “The impacts of systemic racism in medicine are being acknowledged. It is imperative that we now address this important problem and improve the way we represent, report, and include race, SES, and sex in medical research.”
Why We Need Racial Data
“It’s important [to have information on participants’ race] because, as we move forward in research, we’re seeing the implications of minority groups and outcomes in certain contexts,” said senior author Asad Siddiqui, MD, a pediatric anesthesiologist at the Hospital for Sick Children in Toronto and an assistant professor at the University of Toronto.
“This has been highlighted in the COVID-19 pandemic, where we see certain minority groups being impacted to a greater degree. The importance lies in recognizing that race is an important intersectional factor, along with socioeconomic status and sex, that can have implications beyond what we may initially expect when we design clinical trials or studies,” Siddiqui told Medscape Medical News.
In addition, he said, it is important for clinicians to know how representative a study is of his or her patient population when evaluating trial results.
Understanding the Data
Both the representation of minorities in clinical trials and the reporting of it must be improved, Aletha Maybank, MD, chief health equity officer of the American Medical Association, told Medscape Medical News in a written response to questions.
“When we call for the inclusion of race and ethnicity data, we are not implying that there will be differences in safety, efficacy or effectiveness by race or ethnicity on a biological level,” she said. “While we strive to improve the reporting of race and ethnicity data and expand the inclusion and representation of minoritized groups in clinical trials, we must avoid race-based conclusions that reinforce false notions of racial essentialism. This is because racism ― not race ― is the primary driver of inequities in care delivery and outcomes.
“Put simply, what we look like often determines how we’re treated. We need data on race to understand how racism is shaping opportunities and outcomes in health care.”
Maybank referred to a Health Affairs blog post by Rhea Boyd, MD, MPH, and colleagues to explain how racial demographics should be reported in clinical studies. “Their analysis is a direct rebuke of the practice ― common in many health studies, including top-tier journals ― of offering assertions that unmeasured genetic or biological factors account for racial differences in health outcomes. The task is, instead, to use data on race and ethnicity as a way of understanding how racism and other structures of discrimination lead to health inequities.”
Maybank praised the JAMA Network Open article for drawing attention to the underrepresentation of minorities in clinical trials. “We are pleased to see this type of analysis to demonstrate the inequitable distribution of opportunity as it relates to clinical trials by race. The authors demonstrate that even when racial characteristics of trial participants are reported, there are still notable inequities. We need to challenge why people are still excluded from clinical trials and what is operating that allows for this exclusion.”
Siddiqui said that race should not necessarily be a factor in study design. “It depends on the study that’s being conducted, the question being asked, and the variables involved,” he said. “It may be possible to gain insights that aren’t apparent from the original research question. That’s why it’s so important for transparency in reporting race.”
A number of studies have found that outcomes among Black people are poorer than among White persons for COVID-19, diabetes, and other conditions, he noted. “More evidence is coming out about race-based differences in outcomes for certain diseases, which underlines the importance of reporting this [racial] information.”
The authors and commentators have disclosed no relevant financial relationships.
JAMA Netw Open. Published online May 26, 2021. Full text
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