Geanacopoulos Alexandra T, Wu Ann Chen, Bourgeois Florence T, Peltz Alon, Walsh Ryan, Han Amy, Ong Mei-Sing
Division of Emergency Medicine, Boston Children's Hospital, Boston, Mass.
Division of Child Health Research and Policy, Harvard Medical School & Harvard Pilgrim Health Care Institute, Boston, Mass.
J Allergy Clin Immunol Glob. 2024 Jul 26;3(4):100315. doi: 10.1016/j.jacig.2024.100315. eCollection 2024 Nov.
The existing data on enrollment trends of historically underserved racial and ethnic children in clinical trials are limited.
We sought to evaluate documentation and representation of race and ethnicity in pediatric asthma clinical trials in the United States.
This is a cross-sectional study of United States-based interventional trials studying pediatric asthma that were completed between 2008 and 2022 and registered on ClinicalTrials.gov. Enrollment disparities were assessed by using the measure enrollment prevalence difference (EPD) (defined as the median difference between the proportion of participants enrolled and asthma prevalence in the US population by race and ethnicity).
Of the 67 trials reviewed, 53 (79.2%) and 36 (53.7%) reported on race and ethnicity at ClinicalTrials.gov, respectively. Most participants were White (39.1%), Black (37.1%), or non-Hispanic (66.1%). Black, Hispanic, multiracial, and White children were enrolled in the expected proportions based on their contribution to asthma burden. However, American Indian or Alaska Native (AI/AN) (EPD = -1 [95% CI = -1 to -1]) and Asian children (EPD = -3 [95% CI = -3 to -3]) were underrepresented relative to disease burden in these respective groups. Fewer Black children were enrolled in drug or device trials (β = -0.80 [95% CI = -1.60 to -0.01]) than in other trials. Fewer Hispanic children were enrolled in early-phase than late-phase trials (β = -2.42 [95% CI = -3.66 to -1.19]).
Enrollment in pediatric asthma trials conducted in the United States was commensurate with the demographics of children affected by asthma for most racial and ethnic groups, but American Indian or Alaska Native and Asian children were underrepresented. Concerted efforts are needed to promote inclusion of these underserved groups in future trials.
关于历史上未得到充分服务的种族和族裔儿童参与临床试验的趋势，现有数据有限。
我们试图评估美国儿科哮喘临床试验中种族和族裔的记录情况及代表性。
这是一项对2008年至2022年期间在美国完成并在ClinicalTrials.gov上注册的儿科哮喘干预试验的横断面研究。通过使用入组患病率差异（EPD）指标（定义为按种族和族裔划分的试验参与者比例与美国人群哮喘患病率的中位数差异）评估入组差异。
在审查的67项试验中，分别有53项（79.2%）和36项（53.7%）在ClinicalTrials.gov上报告了种族和族裔情况。大多数参与者为白人（39.1%）、黑人（37.1%）或非西班牙裔（66.1%）。黑人、西班牙裔、多种族和白人儿童的入组比例与其在哮喘负担中的占比相符。然而，相对于各自群体中的疾病负担，美国印第安人或阿拉斯加原住民（AI/AN）（EPD = -1 [95% CI = -1至-1]）和亚洲儿童（EPD = -3 [95% CI = -3至-3]）的代表性不足。参与药物或器械试验的黑人儿童（β = -0.80 [95% CI = -1.60至-0.01]）少于其他试验。参与早期试验的西班牙裔儿童少于晚期试验（β = -2.42 [95% CI = -3.66至-1.19]）。
在美国进行的儿科哮喘试验中，大多数种族和族裔群体的入组情况与受哮喘影响儿童的人口统计学特征相符，但美国印第安人或阿拉斯加原住民以及亚洲儿童的代表性不足。需要共同努力，以促进这些未得到充分服务的群体参与未来的试验。
