Division of Emergency Medicine, Boston Children's Hospital, Boston, Massachusetts.
Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.
JAMA Netw Open. 2023 Aug 1;6(8):e2331316. doi: 10.1001/jamanetworkopen.2023.31316.
Enrolling racially and ethnically diverse pediatric research participants is critical to ensuring equitable access to health advances and generalizability of research findings.
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.
National Institutes of Health policies and guidance statements on the reporting of race and ethnicity of participants in NIH-funded clinical trials.
The main outcome was reporting of participant race and ethnicity for NIH-funded pediatric clinical trials in publications and ClinicalTrials.gov.
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.
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.
招募不同种族和民族的儿科研究参与者对于确保公平获得健康进步和研究结果的普遍性至关重要。
检查美国国立卫生研究院（NIH）资助的儿科临床试验中种族和民族的报告情况，并评估与美国人口分布相比，不同种族和民族的儿科参与者的代表性。
设计、地点和参与者：这项横断面研究包括 NIH 资助的儿科（0-17 岁）试验，这些试验的资助资金在 2017 年 1 月 1 日至 2019 年 12 月 31 日之间完成，试验结果截至 2022 年 6 月 30 日报告。
美国国立卫生研究院关于在 NIH 资助的临床试验中报告参与者种族和民族的政策和指导声明。
主要结果是在出版物和 ClinicalTrials.gov 中报告 NIH 资助的儿科临床试验中参与者的种族和民族。
分析中包括 363 项 NIH 资助的儿科试验。出版物和 ClinicalTrials.gov 中报告种族和民族数据的情况相似，其中 90.3%（167/185）的出版物和 93.9%（77/82）的 ClinicalTrial.gov 报告提供了种族和/或民族的数据。在报告种族的 160 篇出版物中，有 43 种不同的种族分类，只有 3 篇出版物（1.9%）使用了 NIH 要求的类别。相比之下，在 ClinicalTrials.gov 中，61 份报告（79.2%）使用 NIH 指定的类别提供了参与者的种族和民族（P<.001）。儿科参与者的种族和民族构成多样化，与美国人口相比，少数种族和族裔群体的代表性过高。
这项对 NIH 资助的儿科临床试验的横断面研究发现，报告参与者种族和民族的比例很高，试验参与者的代表性也很广泛。这些发现表明，NIH 正在履行其确保在其支持的研究中招募多样化参与者的指令。
