Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials.
Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials.
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DOI：
10.1001/jamanetworkopen.2020.37640
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发表时间：
2021-02-01
影响因子：
13.8
通讯作者：
Silver JK
中科院分区：
文献类型：
--
作者：
Flores LE;Frontera WR;Andrasik MP;Del Rio C;Mondríguez-González A;Price SA;Krantz EM;Pergam SA;Silver JK
这项横断面研究检查了与美国人口相比，种族和/或少数民族，女性和老年人在疫苗临床试验中的代表性是否不足。疫苗临床试验是否公平地代表了被认定为代表性不足的种族/民族群体成员的个人，是女性，是65岁或以上的人？在这项涉及219555名参与者的230项美国临床试验的横断面研究中，与美国人口相比，黑人或非裔美国人，美洲印第安人或阿拉斯加原住民，西班牙裔或拉丁裔以及老年人的代表性不足，女性的代表性过高。研究结果表明，在美国进行疫苗试验需要多样化的招募目标。医学研究没有公平地包括少数种族/族裔群体成员或女性和老年人。关于疫苗试验中参与者人口统计学特征的数据有限，尽管这些数据对目前旨在预防2019年冠状病毒病的试验很重要。调查在疫苗临床试验的参与者中，种族/少数民族群体以及女性和老年人的代表性是否不足。这项横断面研究检查了2011年7月1日至2020年6月30日在ClinicalTrials.gov上注册的已完成的美国疫苗试验的数据。术语疫苗、接种、免疫和接种用于识别试验。仅纳入了关于疫苗免疫原性或预防性疫苗有效性的研究。与2011年和2018年美国人口普查数据相比，种族/少数民族，女性和老年人的数量和百分比。次要结局指标是按试验阶段和完成年份纳入。该研究共纳入了230项美国试验，共有219555名受试者。大多数试验是随机的（180 [78.3%]），包括病毒疫苗接种（159 [69.1%]），代表了所有试验阶段。每项试验均报告了年龄和性别; 134项（58.3%）报告了人种，79项（34.3%）报告了种族。总体而言，在成人研究参与者中，白色个体的比例过高（77.9%; 95% CI，77.4%-78.4%），黑人或非裔美国人（10.6%; 95% CI，10.2%-11.0%）和美洲印第安人或阿拉斯加原住民（0.4%; 95%CI，0.3%-0.5%）与美国人口普查数据相比代表性不足;亚裔个人的入学率相似（5.7%; 95%CI，5.5%-6.0%）。即使在报告种族的有限数量的成人试验中，西班牙裔或拉丁裔个体的入组率（11.6%; 95% CI，11.1%-12.0%）也很低。成人试验由更多的女性参与者组成（75 325 [56.0%]），但在报告年龄百分比的受试者中，年龄≥ 65岁的参与者入组率较低（12.1%; 95% CI，12.0%-12.3%）。黑人或非裔美国人受试者（10.1%; 95% CI，9.7%-10.6%）和西班牙裔或拉丁美洲受试者（22.5%; 95% CI，21.6%-23.4%）在儿科试验中的代表性也不足。在报告人种/种族的试验中，65项（48.5%）不包括美洲印第安人或阿拉斯加土著受试者，81项（60.4%）不包括夏威夷人或太平洋岛民受试者。这项横断面研究发现，在美国的疫苗临床试验中，种族/少数民族群体和老年人的代表性不足，而女性成年人的代表性过高。这些发现表明，针对流行病学重要感染的所有疫苗试验都应包括多样性招募目标。
This cross-sectional study examines whether racial and/or ethnic minority, female, and older adults are underrepresented in vaccine clinical trials compared with the US population. Do vaccine clinical trials equitably represent individuals who identify as members of underrepresented racial/ethnic groups, are women, and are people aged 65 years or older? In this cross-sectional study of 230 US-based clinical trials with 219 555 participants, Black or African American, American Indian or Alaska Native, Hispanic or Latino, and older adults were underrepresented and women were overrepresented compared with the US population. The findings suggest that diversity enrollment targets are needed for vaccine trials in the US. Medical research has not equitably included members of racial/ethnic minority groups or female and older individuals. There are limited data on participant demographic characteristics in vaccine trials despite the importance of these data to current trials aimed at preventing coronavirus disease 2019. To investigate whether racial/ethnic minority groups and female and older adults are underrepresented among participants in vaccine clinical trials. This cross-sectional study examined data from completed US-based vaccine trials registered on ClinicalTrials.gov from July 1, 2011, through June 30, 2020. The terms vaccine, vaccination, immunization, and inoculation were used to identify trials. Only those addressing vaccine immunogenicity or efficacy of preventative vaccines were included. The numbers and percentages of racial/ethnic minority, female, and older individuals compared with US census data from 2011 and 2018. Secondary outcome measures were inclusion by trial phase and year of completion. A total of 230 US-based trials with 219 555 participants were included in the study. Most trials were randomized (180 [78.3%]), included viral vaccinations (159 [69.1%]), and represented all trial phases. Every trial reported age and sex; 134 (58.3%) reported race and 79 (34.3%) reported ethnicity. Overall, among adult study participants, White individuals were overrepresented (77.9%; 95% CI, 77.4%-78.4%), and Black or African American individuals (10.6%; 95% CI, 10.2%-11.0%) and American Indian or Alaska Native individuals (0.4%; 95% CI, 0.3%-0.5%) were underrepresented compared with US census data; enrollment of Asian individuals was similar (5.7%; 95% CI, 5.5%-6.0%). Enrollment of Hispanic or Latino individuals (11.6%; 95% CI, 11.1%-12.0%) was also low even among the limited number of adult trials reporting ethnicity. Adult trials were composed of more female participants (75 325 [56.0%]), but among those reporting age as a percentage, enrollment of participants who were aged 65 years or older was low (12.1%; 95% CI, 12.0%-12.3%). Black or African American participants (10.1%; 95% CI, 9.7%-10.6%) and Hispanic or Latino participants (22.5%; 95% CI, 21.6%-23.4%) were also underrepresented in pediatric trials. Among trials reporting race/ethnicity, 65 (48.5%) did not include American Indian or Alaska Native participants and 81 (60.4%) did not include Hawaiian or Pacific Islander participants. This cross-sectional study found that among US-based vaccine clinical trials, members of racial/ethnic minority groups and older adults were underrepresented, whereas female adults were overrepresented. These findings suggest that diversity enrollment targets should be included for all vaccine trials targeting epidemiologically important infections.
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DOI：
10.18549/pharmpract.2016.01.708
发表时间：
2016-01
期刊：
Pharmacy practice
影响因子：
--
作者：
Liu KA;Mager NA
通讯作者：
Mager NA
影响因子：
--
作者：
Corbie-Smith, G;Thomas, SB;St George, DMM
通讯作者：
St George, DMM
美国患有慢性疾病的成年人在流感疫苗接种方面的种族和民族差异因年龄而异
影响因子：
3.7
作者：
Lu D;Qiao Y;Brown NE;Wang J
通讯作者：
Wang J
DOI：
10.15585/mmwr.mm6920a3externalicon
发表时间：
2020-05-22
影响因子：
33.9
作者：
Lickness, Jacquelyn S.;Gardner, Tracie;Anand, Abhijeet
通讯作者：
Anand, Abhijeet
影响因子：
39
作者：
Gupta, Shruti;Hayek, Salim S.;Leaf, David E.
通讯作者：
Leaf, David E.