Women's representation in clinical trials of patients with chronic kidney disease.
chronic kidney disease
randomised clinical trials
sex-disaggregated analysis
women's representation
Journal
Clinical kidney journal
ISSN: 2048-8505
Titre abrégé: Clin Kidney J
Pays: England
ID NLM: 101579321
Informations de publication
Date de publication:
Sep 2023
Sep 2023
Historique:
received:
14
10
2022
medline:
4
9
2023
pubmed:
4
9
2023
entrez:
4
9
2023
Statut:
epublish
Résumé
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.
Sections du résumé
Background
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.
Methods
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.
Results
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.
Conclusion
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.
Identifiants
pubmed: 37664564
doi: 10.1093/ckj/sfad018
pii: sfad018
pmc: PMC10469102
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1457-1464Informations de copyright
© The Author(s) 2023. Published by Oxford University Press on behalf of the ERA.
Déclaration de conflit d'intérêts
M.W. has recently been a consultant for Amgen and Freeline. The other authors declare no conflicts of interest.
Références
Neurology. 2021 Nov 2;97(18):e1768-e1774
pubmed: 34645708
Lancet. 2020 Feb 29;395(10225):709-733
pubmed: 32061315
Sci Rep. 2016 Apr 22;6:24955
pubmed: 27102014
Front Med (Lausanne). 2021 Mar 11;8:643028
pubmed: 33791329
JAMA Netw Open. 2021 Sep 1;4(9):e2124124
pubmed: 34515784
J Am Coll Cardiol. 2018 May 8;71(18):1960-1969
pubmed: 29724348
J Am Soc Nephrol. 2000 Feb;11(2):319-329
pubmed: 10665939
BMJ. 2013 Jan 29;346:f324
pubmed: 23360717
Eur Heart J. 2015 Oct 21;36(40):2677-80
pubmed: 25948737
N Engl J Med. 2002 Dec 19;347(25):2010-9
pubmed: 12490682
Nephrol Dial Transplant. 2017 Feb 1;32(2):348-355
pubmed: 28031344
BMJ Neurol Open. 2022 Sep 5;4(2):e000261
pubmed: 36110923
JAMA Neurol. 2021 Jun 1;78(6):666-677
pubmed: 33900363
Kidney Int Rep. 2022 Sep 02;7(11):2526-2529
pubmed: 36531883
Curr Obes Rep. 2021 Dec;10(4):458-466
pubmed: 34599745
Br J Cancer. 2000 Jun;82(11):1783-8
pubmed: 10839291
J Womens Health (Larchmt). 2013 Jul;22(7):604-16
pubmed: 23768021
Diabetes Metab Syndr. 2020 May - Jun;14(3):181-187
pubmed: 32142999
Cardiol Ther. 2017 Jun;6(1):129-132
pubmed: 27896705
Kidney Int Rep. 2021 Nov 09;7(3):424-435
pubmed: 35257055
Eur Heart J Cardiovasc Pharmacother. 2017 Jul 1;3(3):163-182
pubmed: 28329228
Biol Sex Differ. 2020 Jun 5;11(1):32
pubmed: 32503637
Am J Kidney Dis. 2016 Nov;68(5):743-751
pubmed: 27555103
Res Integr Peer Rev. 2016 May 03;1:2
pubmed: 29451543
J Clin Epidemiol. 2014 Jan;67(1):56-64
pubmed: 24189091
Can J Cardiol. 2019 May;35(5):653-660
pubmed: 31030866
Nat Rev Nephrol. 2018 Mar;14(3):151-164
pubmed: 29355169
JAMA. 2007 Mar 21;297(11):1233-40
pubmed: 17374817
Pharm Pract (Granada). 2016 Jan-Mar;14(1):708
pubmed: 27011778
J Am Soc Nephrol. 2019 Jan;30(1):137-146
pubmed: 30510134
J Am Geriatr Soc. 2019 Feb;67(2):342-346
pubmed: 30693952
J Womens Health (Larchmt). 2018 Oct;27(10):1195-1203
pubmed: 30325292