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.
■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。