Race and ethnicity reporting for clinical trials in ClinicalTrials.gov and publications.
Race and ethnicity reporting for clinical trials in ClinicalTrials.gov and publications.
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DOI：
10.1016/j.cct.2020.106237
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发表时间：
2021-03
影响因子：
2.2
通讯作者：
Williams RJ
中科院分区：
文献类型：
--
作者：
Fain KM;Nelson JT;Tse T;Williams RJ
在临床试验中纳入和随后报告少数群体参与者对于确保外部有效性或检测亚组之间的差异至关重要，然而报告表明，持续存在的差距仍然存在。ClinicalTrials.gov于2017年4月开始要求在提交试验结果时报告种族/族裔信息(如果收集)。在这项研究中，我们从ClinicalTrials.gov下载了试验种族/民族信息，在要求日期之前(N=3540)和之后(N=3542)进行比较。此外，我们检查了10%的随机要求后试验样本，并将其与PubMed上发表的相应结果进行了比较。我们发现，与91.4%的要求后试验相比，42.0%的要求前试验在ClinicalTrials.gov中报告了种族/民族信息；8.6%的要求后试验表明没有收集种族/民族信息。NIH/美国管理和预算办公室(OMB)分类类别在要求前和要求后样本中的使用情况相似(分别为68.4%和70.0%)。在随机抽样中，33.1%的人有相应的结果公布，其中62.4%的人在公布中报告了种族/民族信息。在没有公布种族/民族信息的试验中，90.0%的人在ClinicalTrials.gov上报告了种族/民族信息。这一分析表明，这一要求促进了关于将少数群体纳入研究的信息的公开获得，但仍有进一步的工作要做。
Inclusion and subsequent reporting of minority participants in clinical trials are critical for ensuring external validity or detecting differences among subgroups, however reports suggest that ongoing gaps persist. ClinicalTrials.gov began requiring the reporting of race/ethnicity information (if collected) during results submission for trials in April 2017. For this study, we downloaded trial race/ethnicity information from ClinicalTrials.gov before (N=3540) and after (N=3542) the requirement date for comparison. Additionally, we examined and compared a 10% random sample of post-requirement trials with corresponding results publications available in PubMed. We found that 42.0% of pre-requirement trials compared to 91.4% of post-requirement trials reported race/ethnicity information in ClinicalTrials.gov; 8.6% of post-requirement trials indicated race/ethnicity information was not collected. Use of NIH/U.S. Office of Management and Budget (OMB) classification categories was similar across pre- and post-requirement samples (68.4% and 70.0%, respectively). In the random sample, 33.1% had a corresponding results publication, of which 62.4% reported race/ethnicity information in the publication. Among trials without published race/ethnicity information, 90.0% reported race/ethnicity information on ClinicalTrials.gov. This analysis demonstrates that the requirement has advanced public availability of information on the inclusion of minorities in research, but that further work remains.
影响因子：
105.7
作者：
Ross, Joseph S.;Tse, Tony;Krumholz, Harlan M.
通讯作者：
Krumholz, Harlan M.
影响因子：
120.7
作者：
Webb Hooper, Monica;Napoles, Anna Maria;Perez-Stable, Eliseo J.
通讯作者：
Perez-Stable, Eliseo J.
DOI：
10.1056/nejmsr1611785
发表时间：
2016-11-17
期刊：
The New England journal of medicine
影响因子：
--
作者：
Zarin DA;Tse T;Williams RJ;Carr S
通讯作者：
Carr S