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. 2023 Apr 14:36:11206.
doi: 10.3389/ti.2023.11206. eCollection 2023.

Representation of Women in Contemporary Kidney Transplant Trials

Affiliations

Representation of Women in Contemporary Kidney Transplant Trials

A J Vinson et al. Transpl Int. .

Abstract

Women are often underrepresented in clinical trials. It is unclear if this applies to trials in kidney transplant (KT) and whether the intervention or trial focus influences this. In this study, the weighted participation-to-prevalence ratio (PPR) for women enrollees in KT trials was determined for leading medical transplant or kidney journals between 2018 and 2023 using meta-regression overall and in three sensitivity analyses by: 1) Whether the intervention involved immunosuppression; 2) Area of trial focus; rejection, cardiometabolic, infection, lifestyle, surgical; 3) Whether the intervention was medical/surgical or social/behavioral. Overall, 33.7% of participants in 24 trials were women. The overall pooled PPR for the included trials was 0.80, 95% CI 0.76-0.85, with significant heterogeneity between trials (I 2 56.6%, p-value < 0.001). Women had a lower PPR when the trial involved immunosuppression (PPR 0.77, 95% CI 0.72-0.82) than when it did not (PPR 0.86, 95% CI 0.80-0.94) and were less likely to participate in trials with a medical/surgical versus behavioral intervention; the lowest PPR for women was in studies examining rejection risk (PPR 0.75, 95% CI 0.70-0.81). There is better representation of women in KT trials compared to other medical disciplines, however women remain underrepresented in transplant trials examining immunosuppression and rejection.

Keywords: disparity; gender; participation; sex; trials.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
Pooled participation to prevalence ratio for women in kidney transplant trials between 2018 and 2023.
FIGURE 2
FIGURE 2
Pooled participation to prevalence ratio for women in kidney transplant trials between 2018 and 2023 stratified by whether the intervention (A) Involved immunosuppression or (B) Did not involve immunosuppression.

References

    1. Vinson AJ, Zhang X, Dahhou M, Süsal C, Döhler B, Sapir-Pichhadze R, et al. Age-Dependent Sex Differences in Graft Loss after Kidney Transplantation. Transplantation (2021) 106(7):1473–84. 10.1097/TP.0000000000004026 - DOI - PubMed
    1. Lau A, West L, Tullius SG. The Impact of Sex on Alloimmunity. Trends Immunol (2018) 39(5):407–18. 10.1016/j.it.2018.01.008 - DOI - PubMed
    1. Lepeytre F, Dahhou M, Zhang X, Boucquemont J, Sapir-Pichhadze R, Cardinal H, et al. Association of Sex with Risk of Kidney Graft Failure Differs by Age. J Am Soc Nephrol (2017) 28(10):3014–23. 10.1681/ASN.2016121380 - DOI - PMC - PubMed
    1. Jin X, Chandramouli C, Allocco B, Gong E, Lam CSP, Yan LL. Women's Participation in Cardiovascular Clinical Trials from 2010 to 2017. Circulation (2020) 141(7):540–8. 10.1161/CIRCULATIONAHA.119.043594 - DOI - PubMed
    1. Scott PE, Unger EF, Jenkins MR, Southworth MR, McDowell TY, Geller RJ, et al. Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs. J Am Coll Cardiol (2018) 71(18):1960–9. 10.1016/j.jacc.2018.02.070 - DOI - PubMed