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. 2023 Feb 2;16(9):1457-1464.
doi: 10.1093/ckj/sfad018. eCollection 2023 Sep.

Women's representation in clinical trials of patients with chronic kidney disease

Ana-Catarina Pinho-Gomes  1   2 , Cheryl Carcel  3   4 , Mark Woodward  1   3 , Carinna Hockham  1
Affiliations

Women's representation in clinical trials of patients with chronic kidney disease

Ana-Catarina Pinho-Gomes et al. Clin Kidney J. .

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Keywords: chronic kidney disease; randomised clinical trials; sex-disaggregated analysis; women's representation.

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Conflict of interest statement

M.W. has recently been a consultant for Amgen and Freeline. The other authors declare no conflicts of interest.

Figures

Graphical Abstract
Graphical Abstract
Figure 1:
Figure 1:
Flowchart summarising the selection of trials for the overall analysis and analysis of women's representation.
Figure 2:
Figure 2:
Subgroup analysis of PPR for women. The size of the box is proportional to the number of studies in each category.
Figure 3:
Figure 3:
Women's representation in CKD trials, relative to prevalence, between 2010 and 2021. Dots represent the PPR for each trial plotted by year of publication of primary trial results. The line represents the mean PPR per year.
See this image and copyright information in PMC

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