The National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health, Bethesda, MD, United States of America.
ICF, Bethesda, MD, United States of America.
Contemp Clin Trials. 2021 Feb;101:106237. doi: 10.1016/j.cct.2020.106237. Epub 2020 Dec 5.
Inclusion and subsequent reporting of minority participants in clinical trials are critical for ensuring external validity and 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 and compared trial race/ethnicity information from ClinicalTrials.gov submitted before (N = 3540) and after (N = 3542) the requirement date. 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 slightly higher in the post-requirement (77.1%) compared to pre-requirement (72.8%) samples. Additionally, we examined two 10% random samples of post-requirement trials - one with customized race/ethnicity reporting in ClinicalTrials.gov and the other with corresponding results publications available in PubMed. In the first random sample, 95.9% of customized categories included race information and 52.7% included ethnicity information. In the other 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 to systematically ensure collection and complete reporting of race/ethnicity information.
纳入和随后报告临床试验中的少数参与者对于确保外部有效性和检测亚组之间的差异至关重要，然而报告表明，持续存在差距。ClinicalTrials.gov 于 2017 年 4 月开始要求在试验结果提交时报告种族/民族信息（如果收集）。在这项研究中，我们从 ClinicalTrials.gov 下载并比较了要求日期之前（N=3540）和之后（N=3542）提交的试验种族/民族信息。我们发现，42.0%的要求日期之前的试验与 91.4%的要求日期之后的试验在 ClinicalTrials.gov 中报告了种族/民族信息；8.6%的要求日期之后的试验表明没有收集种族/民族信息。在要求日期之后（77.1%）使用 NIH/美国管理和预算办公室（OMB）分类类别略高于要求日期之前（72.8%）的样本。此外，我们检查了两个要求日期之后的 10%随机试验样本-一个在 ClinicalTrials.gov 中具有定制的种族/民族报告，另一个在 PubMed 中具有相应的结果出版物。在第一个随机样本中，95.9%的定制类别包括种族信息，52.7%包括族裔信息。在另一个随机样本中，33.1%有相应的结果出版物，其中 62.4%在出版物中报告了种族/民族信息。在没有发表种族/民族信息的试验中，90.0%在 ClinicalTrials.gov 上报告了种族/民族信息。这项分析表明，该要求提高了研究中纳入少数群体信息的公开可用性，但仍需进一步努力系统地确保种族/民族信息的收集和完整报告。
