Racial and ethnic representation of youth in type 1 diabetes interventional trials

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2024-09-29 DOI:10.1016/j.cct.2024.107703

Emilie S. Zoltick, Ann Chen Wu, Mei-Sing Ong

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引用次数: 0

Abstract

Background

Underrepresentation of racial and ethnic groups in clinical trials can limit generalizability of research findings and equitable access to treatment. This study evaluates racial and ethnic representation of youth in US-based interventional trials on childhood type 1 diabetes (T1D).

Methods

This cross-sectional study examined interventional trials of T1D conducted in the US and registered on ClinicalTrials.gov. Trials were included if completed as of June 6, 2023, began between years 2010 and 2022, and exclusively enrolled youth ≤19 years old. We assessed representation of racial and ethnic groups in T1D trials, estimated using the enrollment-prevalence difference (EPD).

Results

A total of 106 trials were eligible for inclusion. Of those eligible, 62 (58 %) trials reported participant race or ethnicity and were included in the analyses. Significant disparities in enrollment were observed for American Indian/Alaska Native, Asian/Pacific Islander, Black, and Hispanic youth compared to their respective contribution to disease burden among youth in the US. Disparities in trial enrollment were greatest for Black (EPD, −10.2; 95 % confidence interval [CI], −14.4 to −7.9) and Hispanic (EPD, −7.7; 95 % CI, −12.6 to −4.8) youth. EPDs of trials conducted prior to year 2017 did not differ significantly from those conducted as of year 2017.

Conclusions

Historically marginalized racial and ethnic youth were underrepresented in T1D trials. Strategies to improve recruitment of these populations are needed to reduce inequities in diabetes treatment and outcomes.

查看原文本刊更多论文

1 型糖尿病干预试验中青年的种族和民族代表性。

背景：种族和民族群体在临床试验中的代表性不足会限制研究结果的普遍性和公平获得治疗的机会。本研究评估了美国儿童 1 型糖尿病（T1D）干预试验中青年的种族和民族代表性：这项横断面研究考察了在美国进行并在 ClinicalTrials.gov 上注册的 1 型糖尿病干预试验。如果试验是在 2023 年 6 月 6 日之前完成的，在 2010 年至 2022 年期间开始的，并且只招募了年龄小于 19 岁的青少年，则纳入这些试验。我们评估了T1D试验中种族和民族群体的代表性，并使用入组-患病率差异（EPD）进行了估算：结果：共有 106 项试验符合纳入条件。结果：共有 106 项试验符合纳入条件，其中 62 项（58%）试验报告了参与者的种族或民族，并纳入了分析。美国印第安人/阿拉斯加原住民、亚裔/太平洋岛民、黑人和西班牙裔青少年的试验登记人数与他们各自在美国青少年疾病负担中所占的比例相比存在显著差异。黑人（EPD，-10.2；95% 置信区间[CI]，-14.4 至 -7.9）和西班牙裔（EPD，-7.7；95% 置信区间[CI]，-12.6 至 -4.8）青少年的试验注册率差距最大。2017年之前进行的试验的EPD与截至2017年进行的试验的EPD没有显著差异：历史上被边缘化的种族和民族青年在T1D试验中的代表性不足。需要制定策略来改善这些人群的招募情况，以减少糖尿病治疗和结果中的不公平现象。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.