Pinho-Gomes Ana-Catarina, Carcel Cheryl, Woodward Mark, Hockham Carinna
The George Institute for Global Health, Imperial College London, UK.
Institute of Health Informatics, University College London, London, UK.
Clin Kidney J. 2023 Feb 2;16(9):1457-1464. doi: 10.1093/ckj/sfad018. eCollection 2023 Sep.
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.
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.
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.
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.
慢性肾脏病（CKD）中的性别差异，包括流行病学和对治疗的反应，目前仍知之甚少。本研究旨在调查CKD临床试验中女性的参与情况，以及是否报告了按性别分类的结果。
从ClinicalTrials.gov上识别出CKD的临床试验。选择≥100名参与者的随机3/4期试验，通过计算参与率：患病率比（PPR）来量化女性在参与者中的占比，并调查是否进行了按性别分类的分析。
总共纳入了192项于1995年至2022年间在ClinicalTrials.gov上注册并发表的CKD试验。总体而言，在147136名参与者中，女性占66875名（45%）。女性参与临床试验的比例低于她们在全球CKD基础人群中的占比（55%）。PPR为0.75（95%置信区间0.72 - 0.78），无论平均年龄、CKD分期、透析、地点、干预类型或资助机构如何，均无显著差异。共有39项（20%）试验报告了按性别分类的疗效结果，无一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她们在CKD基础人群中的占比。按性别分类的疗效和安全性结果很少被报告。提高女性参与临床试验的比例对于进行按性别分类的分析至关重要，从而识别男女之间治疗反应的潜在差异。
