Danish Centre for Studies in Research and Research Policy, Aarhus University, Aarhus, Denmark.
Department of Sociology, University of Copenhagen, Copenhagen, Denmark.
Nat Commun. 2021 Jul 6;12(1):4015. doi: 10.1038/s41467-021-24265-8.
Sex and gender differences impact the incidence of SARS-CoV-2 infection and COVID-19 mortality. Furthermore, sex differences influence the frequency and severity of pharmacological side effects. A large number of clinical trials to develop new therapeutic approaches and vaccines for COVID-19 are ongoing. We investigated the inclusion of sex and/or gender in COVID-19 studies on ClinicalTrials.gov, collecting data for the period January 1, 2020 to January 26, 2021. Here, we show that of the 4,420 registered SARS-CoV-2/COVID-19 studies, 935 (21.2%) address sex/gender solely in the context of recruitment, 237 (5.4%) plan sex-matched or representative samples or emphasized sex/gender reporting, and only 178 (4%) explicitly report a plan to include sex/gender as an analytical variable. Just eight (17.8%) of the 45 COVID-19 related clinical trials published in scientific journals until December 15, 2020 report sex-disaggregated results or subgroup analyses.
性别差异会影响 SARS-CoV-2 感染的发生率和 COVID-19 的死亡率。此外，性别差异还会影响药物副作用的发生频率和严重程度。目前有大量针对 COVID-19 的临床试验正在进行，旨在开发新的治疗方法和疫苗。我们调查了 ClinicalTrials.gov 上的 COVID-19 研究中是否纳入了性别因素，数据收集时间为 2020 年 1 月 1 日至 2021 年 1 月 26 日。结果显示，在已注册的 4420 项与 SARS-CoV-2/COVID-19 相关的研究中，935 项（21.2%）仅在招募阶段考虑了性别因素，237 项（5.4%）计划进行性别匹配或有代表性的样本研究，或强调性别报告，仅有 178 项（4%）明确表示将性别作为分析变量纳入研究计划。截至 2020 年 12 月 15 日，在已发表的与 COVID-19 相关的临床试验中，仅有 8 项（17.8%）报告了按性别分类的结果或亚组分析。
