Abstract：
To promote health equity within the United States (US), randomized clinical trials should strive for unbiased representation. Thus, there is impetus to identify demographic disparities overall and by disease category in US clinical trial recruitment, by trial phase, level of masking, and multi-center status, relative to national demographics. A systematic review and meta-analysis were conducted using MEDLINE, Embase, CENTRAL, and ClinicalTrials.gov, between 01/01/2008 to 12/30/2019. Clinical trials (N = 5,388) were identified based on the following inclusion criteria: study type, location, phase, and participant age. Each clinical trial was independently screened by two researchers. Data was pooled using a random-effects model. Median proportions for gender, race, and ethnicity of each trial were compared to the 2010 US Census proportions, matched by age. A second analysis was performed comparing gender, race, and ethnicity proportions by trial phase, multi-institutional status, quality, masking, and study start year. 2977 trials met inclusion criteria (participants, n = 607,181) for data extraction. 36% of trials reported ethnicity and 53% reported race. Three trials (0.10%) included transgender participants (n = 5). Compared with 2010 US Census data, females (48.3%, 95% CI 47.2-49.3, p < 0.0001), Hispanics (11.6%, 95% CI 10.8-12.4, p < 0.0001), American Indians and Alaskan Natives (AIAN, 0.19%, 95% CI 0.15-0.23, p < 0.0001), Asians (1.27%, 95% CI 1.13-1.42, p < 0.0001), Whites (77.6%, 95% CI 76.4-78.8, p < 0.0001), and multiracial participants (0.25%, 95% CI 0.21-0.31, p < 0.0001) were under-represented, while Native Hawaiians and Pacific Islanders (0.76%, 95% CI 0.71-0.82, p < 0.0001) and Blacks (17.0%, 95% CI 15.9-18.1, p < 0.0001) were over-represented. Inequitable representation was mirrored in analysis by phase, institutional status, quality assessment, and level of masking. Between 2008 to 2019 representation improved for only females and Hispanics. Analysis stratified by 44 disease categories (i.e., psychiatric, obstetric, neurological, etc.) exhibited significant yet varied disparities, with Asians, AIAN, and multiracial individuals the most under-represented. These results demonstrate disparities in US randomized clinical trial recruitment between 2008 to 2019, with the reporting of demographic data and representation of most minorities not having improved over time.
摘要：
为了促进美国(US)内部的卫生公平，随机临床试验应争取公正的代表性.因此，在美国临床试验招募中，有动力确定总体和疾病类别的人口差异，在试验阶段，水平的掩蔽，和多中心状态，相对于国家人口。使用MEDLINE进行了系统评价和荟萃分析，Embase,中部,和ClinicalTrials.gov,2008年1月1日至2019年12月30日之间。临床试验（N=5,388）是根据以下纳入标准确定的：研究类型，location,阶段,参与者年龄。每个临床试验由两名研究人员独立筛选。使用随机效应模型汇集数据。性别比例的中位数，种族,每个试验的种族与2010年美国人口普查比例进行了比较，与年龄相匹配。第二个分析是比较性别，种族,按试验阶段划分的种族比例，多机构地位，质量,掩蔽,学习开始年。2977项试验符合纳入标准(参与者，n=607,181)用于数据提取。36%的试验报告了种族，53%报告了种族。三项试验（0.10％）包括跨性别参与者（n=5）。与2010年美国人口普查数据相比，女性(48.3%,95%CI47.2-49.3，p<0.0001），西班牙裔（11.6%，95%CI10.8-12.4，p<0.0001），美洲印第安人和阿拉斯加土著人(AIAN，0.19%，95%CI0.15-0.23，p<0.0001)，亚洲人（1.27%，95%CI1.13-1.42，p<0.0001)，白人（77.6%，95%CI76.4-78.8，p<0.0001），和多种族参与者(0.25%，95%CI0.21-0.31，p<0.0001)表示不足，而夏威夷原住民和太平洋岛民(0.76%，95%CI0.71-0.82，p<0.0001）和黑人（17.0%，95%CI15.9-18.1，p<0.0001)过高。不公平的表示反映在按阶段的分析中，机构地位,质量评估，和水平的掩蔽。在2008年至2019年期间，只有女性和西班牙裔的代表性有所改善。按44种疾病类别分层的分析(即，精神病学,产科,神经学,等。)表现出显著但各不相同的差异，亚洲人,AIAN,和多种族的个人代表最不足。这些结果表明，在2008年至2019年期间，美国随机临床试验招募的差异，人口统计数据的报告和大多数少数民族的代表性没有随着时间的推移而改善。
