关键词: Multiple sclerosis ethnicity inequalities race representativeness

Mesh : Humans Multiple Sclerosis / ethnology therapy Clinical Trials, Phase III as Topic Ethnicity Racial Groups

来  源:   DOI:10.1177/13524585241254283

Abstract:
UNASSIGNED: Distinctive differences in multiple sclerosis (MS) have been observed by race and ethnicity. We aim to (1) assess how often race and ethnicity were reported in clinical trials registered on ClinicalTrials.gov, (2) evaluate whether the population was diverse enough, and (3) compare with publications.
UNASSIGNED: We included phase 3 clinical trials registered with results on ClinicalTrials.gov between 2007 and 2023. When race and/or ethnicity were reported, we searched for the corresponding publications.
UNASSIGNED: Out of the 99 included studies, 56% reported race and/or ethnicity, of which only 26% of those primarily completed before 2017. Studies reporting race or ethnicity contributed to a total of 33,891 participants, mainly enrolled in Eastern Europe. Most were White (93%), and the median percentage of White participants was 93% (interquartile range (IQR) = 86%-98%), compared to 3% for Black (IQR = 1%-12%) and 0.2% for Asian (IQR = 0%-1%). Four trials omitted race and ethnicity in publications and even when information was reported, some discrepancies in terminology were identified and categories with fewer participants were often collapsed.
UNASSIGNED: More efforts should be done to improve transparency, accuracy, and representativeness, in publications and at a design phase, by addressing social determinants of health that historically limit the enrollment of underrepresented population.
摘要:
根据种族和种族观察到多发性硬化症(MS)的明显差异。我们的目标是(1)评估在ClinicalTrials.gov上注册的临床试验中报告种族和种族的频率,(2)评估人口是否足够多样化,(3)与出版物进行比较。
我们包括了2007年至2023年在ClinicalTrials.gov上注册的3期临床试验。当报告种族和/或民族时,我们搜索了相应的出版物。
在纳入的99项研究中,56%的人报告了种族和/或族裔,其中只有26%的项目主要在2017年之前完成。报告种族或种族的研究促成了总共33,891名参与者。主要在东欧注册。大多数是白人(93%),白人参与者的中位数百分比为93%(四分位数间距(IQR)=86%-98%),相比之下,黑人为3%(IQR=1%-12%),亚洲为0.2%(IQR=0%-1%)。四项试验在出版物中甚至在报告信息时都省略了种族和族裔,确定了术语上的一些差异,参与者较少的类别通常会被折叠.
应该做更多的努力来提高透明度,准确度,和代表性,在出版物和设计阶段,通过解决历史上限制代表性不足人口入学的健康社会决定因素。
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