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. 2023 Aug 1;6(8):e2331316.
doi: 10.1001/jamanetworkopen.2023.31316.

Reporting and Representation of Participant Race and Ethnicity in National Institutes of Health-Funded Pediatric Clinical Trials

Lois K Lee  1   2   3   4 , Claire Narang  5 , Chris A Rees  6 , Ravi R Thiagarajan  2   3   7 , Patrice Melvin  3   4 , Valerie Ward  3   4   8   9 , Florence T Bourgeois  1   2   5
Affiliations

Reporting and Representation of Participant Race and Ethnicity in National Institutes of Health-Funded Pediatric Clinical Trials

Lois K Lee et al. JAMA Netw Open. .

Abstract

Importance: Enrolling racially and ethnically diverse pediatric research participants is critical to ensuring equitable access to health advances and generalizability of research findings.

Objectives: To examine the reporting of race and ethnicity for National Institutes of Health (NIH)-funded pediatric clinical trials and to assess the representation of pediatric participants from different racial and ethnic groups compared with distributions in the US population.

Design, setting, and participants: This cross-sectional study included NIH-funded pediatric (ages 0-17 years) trials with grant funding completed between January 1, 2017, and December 31, 2019, and trial results reported as of June 30, 2022.

Exposures: National Institutes of Health policies and guidance statements on the reporting of race and ethnicity of participants in NIH-funded clinical trials.

Main outcomes and measures: The main outcome was reporting of participant race and ethnicity for NIH-funded pediatric clinical trials in publications and ClinicalTrials.gov.

Results: There were 363 NIH-funded pediatric trials included in the analysis. Reporting of race and ethnicity data was similar in publications and ClinicalTrials.gov, with 90.3% (167 of 185) of publications and 93.9% (77 of 82) of ClinicalTrial.gov reports providing data on race and/or ethnicity. Among the 160 publications reporting race, there were 43 different race classifications, with only 3 publications (1.9%) using the NIH-required categories. By contrast, in ClinicalTrials.gov, 61 reports (79.2%) provided participant race and ethnicity using the NIH-specified categories (P < .001). There was racially and ethnically diverse enrollment of pediatric participants, with overrepresentation of racial and ethnic minority groups compared with the US population.

Conclusions and relevance: This cross-sectional study of NIH-funded pediatric clinical trials found high rates of reporting of participant race and ethnicity, with diverse representation of trial participants. These findings suggest that the NIH is meeting its directive of ensuring diverse participant enrollment in the research it supports.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Thiagarajan reported receiving grants from the US Department of Defense and speaker’s honoraria from the Society of Critical Care Medicine and the Extracorporeal Life Support Organization outside the submitted work. Dr Ward reported receiving personal fees from and being a health equity advisor for the Children and Youth with Special Health Care Needs Research Network (CYSHCNet) and receiving personal fees for being a member of the National Project Advisory Committee from the Institute for Patient- and Family-Centered Care and Cincinnati Children's Hospital Medical Center funded by the Lucile Packard Foundation for Children’s Health outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. Study Flow Diagram
Flow diagram for selection of National Institutes of Health (NIH)–funded pediatric clinical trials with publications or results reported in ClinicalTrials.gov.
See this image and copyright information in PMC

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