PDF(Pubmed)
Abstract：
UNASSIGNED: Sex and gender differences in chronic kidney disease (CKD), including epidemiology and response to treatment, remain poorly understood. This study aimed to investigate how women are represented in CKD clinical trials and whether sex- and gender-disaggregated outcomes were reported.
UNASSIGNED: Clinical trials on CKD were identified from ClinicalTrials.gov. Randomised, phase 3/4 trials with ≥100 participants were selected to quantify women\'s representation among participants by computing the participation:prevalence ratio (PPR) and investigating whether sex-disaggregated analyses had been performed.
UNASSIGNED: In total, 192 CKD trials registered on ClinicalTrials.gov and published between 1995 and 2022 were included. Overall, women accounted for 66 875 (45%) of the 147 136 participants. Women\'s participation in clinical trials was lower than their representation in the underlying CKD population globally (55%). The PPR was 0.75 (95% confidence interval 0.72-0.78), with no significant variation irrespective of mean age, CKD stage, dialysis, location, type of intervention or funding agency. A total of 39 (20%) trials reported sex-disaggregated efficacy outcomes and none reported sex-disaggregated safety outcomes.
UNASSIGNED: Women\'s participation in CKD clinical trials was lower than their representation in the underlying CKD population. Sex-disaggregated efficacy and safety outcomes were rarely reported. Improving women\'s enrolment into clinical trials is crucial to enable sex- and gender-disaggregated analysis and thus identify potential differences in treatment response between women and men.
UNASSIGNED: Clinical trials on CKD were identified from ClinicalTrials.gov. Randomised, phase 3/4 trials with ≥100 participants were selected to quantify women\'s representation among participants by computing the participation:prevalence ratio (PPR) and investigating whether sex-disaggregated analyses had been performed.
UNASSIGNED: In total, 192 CKD trials registered on ClinicalTrials.gov and published between 1995 and 2022 were included. Overall, women accounted for 66 875 (45%) of the 147 136 participants. Women\'s participation in clinical trials was lower than their representation in the underlying CKD population globally (55%). The PPR was 0.75 (95% confidence interval 0.72-0.78), with no significant variation irrespective of mean age, CKD stage, dialysis, location, type of intervention or funding agency. A total of 39 (20%) trials reported sex-disaggregated efficacy outcomes and none reported sex-disaggregated safety outcomes.
UNASSIGNED: Women\'s participation in CKD clinical trials was lower than their representation in the underlying CKD population. Sex-disaggregated efficacy and safety outcomes were rarely reported. Improving women\'s enrolment into clinical trials is crucial to enable sex- and gender-disaggregated analysis and thus identify potential differences in treatment response between women and men.
摘要：
■慢性肾脏病（CKD）的性别和性别差异，包括流行病学和对治疗的反应，仍然知之甚少。本研究旨在调查女性在CKD临床试验中的代表性，以及是否报告了按性别和性别分类的结果。
■CKD的临床试验来自ClinicalTrials.gov。随机化,我们选择了≥100名参与者的3/4期试验,通过计算参与者:患病率比(PPR)和调查是否进行了按性别分列的分析来量化参与者中女性的代表性.
■总共，纳入了在ClinicalTrials.gov上注册并在1995年至2022年之间发布的192项CKD试验。总的来说,147.136名参与者中,女性占66.875人(45%).全球女性参与临床试验的比例低于其在基础CKD人群中的比例（55%）。PPR为0.75(95%置信区间0.72-0.78)，无论平均年龄如何，都没有明显的变化，CKD阶段，透析,location,干预或资助机构的类型。共有39项（20％）试验报告了按性别分类的疗效结果，没有一项报告按性别分类的安全性结果。
■女性参与CKD临床试验的比例低于其在基础CKD人群中的比例。按性别分列的疗效和安全性结果很少报告。提高妇女参加临床试验的人数对于实现按性别和性别分类的分析，从而确定男女治疗反应的潜在差异至关重要。
■CKD的临床试验来自ClinicalTrials.gov。随机化,我们选择了≥100名参与者的3/4期试验,通过计算参与者:患病率比(PPR)和调查是否进行了按性别分列的分析来量化参与者中女性的代表性.
■总共，纳入了在ClinicalTrials.gov上注册并在1995年至2022年之间发布的192项CKD试验。总的来说,147.136名参与者中,女性占66.875人(45%).全球女性参与临床试验的比例低于其在基础CKD人群中的比例（55%）。PPR为0.75(95%置信区间0.72-0.78)，无论平均年龄如何，都没有明显的变化，CKD阶段，透析,location,干预或资助机构的类型。共有39项（20％）试验报告了按性别分类的疗效结果，没有一项报告按性别分类的安全性结果。
■女性参与CKD临床试验的比例低于其在基础CKD人群中的比例。按性别分列的疗效和安全性结果很少报告。提高妇女参加临床试验的人数对于实现按性别和性别分类的分析，从而确定男女治疗反应的潜在差异至关重要。
