Coughlin Catherine G, Zoltick Emilie S, Stanford Fatima Cody, Ong Mei-Sing
Division of Emergency Medicine, Boston Children's Hospital, Boston, Massachusetts, USA.
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Obesity (Silver Spring). 2025 Mar;33(3):560-566. doi: 10.1002/oby.24228. Epub 2025 Feb 4.
The objective of this study was to examine the representation of historically marginalized racial and ethnic groups in pediatric obesity clinical trials.
We performed a cross-sectional analysis of clinical trials in pediatric obesity (participants aged ≤18 years) that were registered in ClinicalTrials.gov, were completed from January 2013 to August 2023, and were conducted in the United States. We quantified disparities in trial enrollment by calculating the enrollment-prevalence disparity (EPD) for each racial and ethnic group.
A total of 260 trials met eligibility criteria, of which 128 trials (49.2%) reported race and/or ethnicity data. Enrollment of White, Hispanic, and Black children roughly reflects disease burden in these populations. However, relative to disease burden, Asian (EPD, -3.7%; IQR, -3.7% to 1.8%; p < 0.0001), American Indian and Alaska Native (EPD, -2.1%; IQR, -2.1% to -2.1%; p < 0.0001), and Native Hawaiian or other Pacific Islander (EPD, -0.6%; IQR, -0.6% to -0.6%; p < 0.0001) children were significantly underrepresented in these trials.
With the exception of Black and Hispanic children, historically marginalized racial groups were underrepresented in pediatric obesity trials, signifying a need to improve diversity of participants in these trials. Additionally, there are substantial gaps in the documentation of race and ethnicity information. Concerted efforts are needed to ensure adequate reporting of race and ethnicity information in clinical trials.
本研究的目的是调查历史上处于边缘地位的种族和族裔群体在儿科肥胖临床试验中的代表性。
我们对在ClinicalTrials.gov上注册、于2013年1月至2023年8月完成且在美国进行的儿科肥胖（参与者年龄≤18岁）临床试验进行了横断面分析。我们通过计算每个种族和族裔群体的入组患病率差异（EPD）来量化试验入组中的差异。
共有260项试验符合纳入标准，其中128项试验（49.2%）报告了种族和/或族裔数据。白人、西班牙裔和黑人儿童的入组情况大致反映了这些人群中的疾病负担。然而，相对于疾病负担，亚洲儿童（EPD，-3.7%；IQR，-3.7%至1.8%；p<0.0001）、美洲印第安人和阿拉斯加原住民儿童（EPD，-2.1%；IQR，-2.1%至-2.1%；p<0.0001）以及夏威夷原住民或其他太平洋岛民儿童（EPD，-0.6%；IQR，-0.6%至-0.6%；p<0.0001）在这些试验中的代表性明显不足。
除了黑人和西班牙裔儿童外，历史上处于边缘地位的种族群体在儿科肥胖试验中的代表性不足，这表明需要提高这些试验中参与者的多样性。此外，种族和族裔信息的记录存在很大差距。需要共同努力以确保临床试验中种族和族裔信息的充分报告。
