Abstract
Background
Although it is known that women do not participate in trials as frequently as men,
there are limited recent data examining how women recruitment has changed over time.
Methods
We conducted MEDLINE search using a validated strategy for randomized trials published
in New England Journal of Medicine, Lancet, and Journal of the American Medical Association between 1986 and 2015, and included trials evaluating pharmacologic or nonpharmacologic
therapies. We abstracted data on demographics, intervention type, clinical indication,
and trial design characteristics, and examined their relationships with women enrollment.
Results
In total, 598 trials met inclusion criteria. Women enrollment increased significantly
over time (21% between 1986 and 1990 to 33% between 2011 and 2015; Pfor trend < 0.001) and did not differ by journal or funding source. Women enrollment varied
with clinical indication, comprising 37% for non–coronary artery disease vascular
trials, 30% for coronary artery disease trials, 28% for heart failure trials, and
28% for arrhythmia trials (P < 0.001), which were all significantly lower than the expected proportion in disease
populations (P < 0.001). Women enrollment varied with trial type (31%, 29%, and 26% for pharmacologic,
device, and procedural trials, respectively; P = 0.001). These findings were corroborated using multivariable analysis. We found
significant positive correlations between women enrolled, and mean age and total number
of participants. Fewer women were enrolled in trials reporting statistically significant
results than those who did not (P = 0.001).
Conclusions
Although enrollment of women has increased over time, it remains lower than the relative
proportion in the disease population. Future studies should elucidate the reasons
for persistent under-representation of women in clinical trials.
Résumé
Contexte
Si l’on sait que les femmes ne participent pas aux essais cliniques aussi fréquemment
que les hommes, rares sont cependant les données récentes sur l’évolution du nombre
de femmes recrutées au fil du temps.
Méthodologie
Nous avons utilisé une stratégie validée pour rechercher dans MEDLINE les essais cliniques
randomisés portant sur des traitements tant pharmacologiques que non pharmacologiques
publiés dans les revues New England Journal of Medicine, Lancet et Journal of the American Medical Association entre 1986 et 2015. Nous avons abrégé les données sur les caractéristiques démographiques,
le type d’intervention, l’indication clinique et le plan de l’essai et avons examiné
leurs liens avec le recrutement des femmes.
Résultats
Au total, 598 essais cliniques satisfaisaient aux critères d’inclusion. Le recrutement
des femmes a augmenté de façon significative avec le temps (de 21 % entre 1986 et
1990 à 33 % entre 2011 et 2015; ppour la tendance < 0,001), sans aucune variation en fonction de la revue ou de la source de financement.
Le recrutement des femmes variait en fonction de l’indication clinique : 37 % dans
les essais sur les maladies vasculaires ne portant pas sur les artères coronaires,
30 % dans les essais sur les coronaropathies, 28 % dans les essais sur l’insuffisance
cardiaque et 28 % dans les essais sur l’arythmie (p < 0,001), des chiffres qui sont dans tous les cas significativement inférieurs à
la proportion attendue dans chaque population des patients atteints (p < 0,001). Le recrutement des femmes variait en fonction du type d’essai clinique
(31 %, 29 % et 26 % pour les essais portant respectivement sur des produits pharmaceutiques,
des dispositifs et des interventions; p = 0,001). Ces constatations ont été corroborées par une analyse multivariée. Nous
avons observé des corrélations positives significatives entre le nombre de femmes
recrutées et l’âge moyen et le nombre total de participants. Les femmes étaient moins
nombreuses à être recrutées dans les essais rapportant des résultats statistiquement
significatifs que dans ceux dont les résultats ne l’étaient pas (p = 0,001).
Conclusions
Même s’il a augmenté au fil du temps, le nombre de femmes recrutées demeure inférieur
à la proportion relative dans la population totale des personnes atteintes. Des études
ultérieures sont nécessaires pour permettre de comprendre les raisons de cette sous-représentation
persistante des femmes dans les essais cliniques.
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Article info
Publication history
Published online: January 29, 2019
Accepted:
January 22,
2019
Received:
October 17,
2018
Footnotes
See editorial by Pacheco and Bairey Merz, pages 552–554 of this issue.
See page 659 for disclosure information.
Identification
Copyright
© 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
ScienceDirect
Access this article on ScienceDirectLinked Article
- Underrepresentation of Women in Cardiovascular Randomized Clinical TrialsCanadian Journal of CardiologyVol. 36Issue 6
- Women in Cardiovascular Clinical Trials—What Are the Barriers to Address to Improve Enrollment?Canadian Journal of CardiologyVol. 35Issue 5
- PreviewAlthough the prevalence of cardiovascular disease (CVD) among women is similar to that of men, women have been historically under-represented in clinical trials. This under-representation represents a barrier in the application of treatments to women, and likely continues to contribute to the knowledge gaps in the understanding and treatment of CVD in women. Indeed, contemporary data show increasing rates of hospitalizations for acute myocardial infarction (AMI)1 and stagnation of cardiovascular mortality in women younger than 50 years,2 suggesting that persistent hurdles in diagnosis, treatment, and care of women still exist today.
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