Reporting of Participant Race and Ethnicity in Published US Pediatric Clinical Trials From 2011 to 2020

Abstract

of participants who are members of racial and ethnic minority groups in clinical trials enhances inclusivity in the scientific process and generalizability of results.OBJECTIVE To assess participant race and ethnicity in pediatric clinical trials published from 2011 to 2020. DESIGN, SETTING, AND PARTICIPANTSThis cross-sectional study examined articles reporting pediatric clinical trials conducted in the US published in 5 leading general pediatric and 5 leading general medical journals from January 1, 2011, to December 31, 2020. MAIN OUTCOMES AND MEASURESReporting of participant race and ethnicity and comparison of enrolled participants vs US census populations of pediatric racial and ethnic groups in published clinical trials. RESULTSThe study included 612 articles reporting pediatric clinical trials during the study period, with 565 618 total participants (median per trial, 200 participants [IQR, 90-571 participants]). Of the 612 articles, 486 (79.4%) reported participant race and 338 (55.2%) reported participant ethnicity. From 2011 to 2020, relative rates of reporting of participant race increased by 7.9% per year (95% CI, 0.2%-16.3% per year) and reporting of ethnicity increased by 11.4% per year (95% CI, 4.8%-18.4% per year). Among articles reporting race and ethnicity, the method of assignment was not reported in 261 of 511 articles (51.1%) and 207 of 359 articles (57.7%), respectively. Black/African American children were enrolled proportionally more than the US population of Black/African American children (odds ratio [OR], 1.88; 95% CI, 1.87-1.89). Hispanic/Latino children were enrolled commensurately with the US population of Hispanic/Latino children (OR, 1.02; 95% CI, 1.01-1.03). American Indian/Alaska Native (OR, 0.82; 95% CI, 0.79-0.85), Asian (OR, 0.56; 95% CI, 0.55-0.57), and Native Hawaiian/Pacific Islander (OR, 0.66; 95% CI, 0.61-0.72) children were enrolled significantly less compared with the respective US populations of these groups. White children were enrolled less than expected (OR, 0.84; 95% CI, 0.84-0.85) but represented 188 156 (46.0%) of participants in trials reporting race or ethnicity. CONCLUSIONS AND RELEVANCEThis cross-sectional study revealed that the proportion of published pediatric clinical trials that reported participant race and ethnicity increased from 2011 to 2020, but participant race and ethnicity were still underreported. Disparities existed in pediatric clinical trial enrollment of American Indian/Alaska Native, Asian, and Native Hawaiian/Pacific Islander children. The greater representation of Black/African American children compared with the US population suggests inclusive research practices that could be extended to other historically disenfranchised racial and ethnic groups.

Identifying and addressing disparities in the evaluation and treatment of children with growth hormone deficiency

“…Female infants compared to males had higher rate of post-cardiac surgery mortality ( 14 ). Even in pediatric clinical trials, representation of Black children has increased in the last decade, although still underrepresented, however disparities still exist in the enrollment of American Indian/Alaska Native, Asian, and Native Hawaiian/Pacific Islander children ( 15 ).…”

Underrepresentation of Asians in pediatric health services research

“…To increase the diversity and inclusion of pediatric health services research, we can learn from previous studies which have been effective at recruiting Asian patients(2,4,6,7). First, we must move away from a lens of Asian American exceptionalism and the “Model Minority.” These constructs serve to bias perceptions that Asian Americans are not impacted by health disparities and do not experience a spectrum of risk similar to other communities of color.…”

“…To increase the diversity and inclusion of pediatric health services research, we can learn from previous studies which have been effective at recruiting Asian patients (2,4,6,7). First, we must move away from a lens of Asian American exceptionalism and the "Model Minority. "…”

“…Data‐driven and public pressures have resulted in better representation over the past decade for some racial groups, including Black and African American youth(2). However, Asian and Pacific Islander youth continue to be significantly and consistently the most underrepresented in health services research and high‐impact medical research studies, despite being the fastest‐growing racial or ethnic group in the US(2,3). According to census reports, the population of Asian Americans grew 81% this past decade and their population is projected to pass 35 million by 2060(3).…”

Indigenous peoples and inclusion in clinical and genomic research: Understanding the history and navigating contemporary engagement

“…In the United States, Indigenous childhood and adolescent cancer survival is worse than non-Hispanic white children and adolescents and the disparities are greatest for cancers amenable to medical intervention [20] . Further, disparities exist for American Indian/Alaskan Native children [21] in pediatric clinical trials and relevant genomic research participation. This hampers subsequent research in outcomes and therapy development that most effectively reach Indigenous Peoples.…”