P.024 Sex and gender reporting in clinical trials among neurological US Food and Drug Administration approvals

L. Cooper-Brown, J. Chen, A. Ebadi, L. Wilson, J. Xie, B. Bernhardt, E. Bui
{"title":"P.024 Sex and gender reporting in clinical trials among neurological US Food and Drug Administration approvals","authors":"L. Cooper-Brown, J. Chen, A. Ebadi, L. Wilson, J. Xie, B. Bernhardt, E. Bui","doi":"10.1017/cjn.2024.131","DOIUrl":null,"url":null,"abstract":"Background: Sex and gender are related but distinct determinants of disease, treatment response, and research reproducibility whose consideration is increasingly required for research funding. Nevertheless, the quality of sex and gender reporting in neurological randomized controlled trials (RCTs) remains unknown. Methods: This ongoing study of RCTs associated with Food and Drug Administration neurological drug approvals aims to determine the frequency of accurate reporting of RCT participants’ sex and gender. Secondary outcomes include changes in reporting over time and RCT design characteristics. Results: Preliminary analysis included 145 RCTs (153,410 participants) associated with 77 medications approved in 1985-2023, most commonly for epilepsy (19%), migraine (16%), and multiple sclerosis (16%). Sixty-six RCTs (45.5%) used sex-related terms appropriately. Nine RCTs (6.2%) reported gender accurately. Fifty-three RCTs (37%) used sex- or gender-related terms interchangeably. There are no statistically significant differences in the proportions of studies reporting sex and/or gender accurately when comparing those published until versus after 2017. No RCT reported sex or gender collection methods, definitions of sex or gender, or including sex or gender minority participants. Conclusions: Preliminary results suggest shortcomings in reporting sex and, especially, gender accurately and inclusively among neurological drug RCTs and no significant improvement thereof in recent years.","PeriodicalId":9571,"journal":{"name":"Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques","volume":"60 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1017/cjn.2024.131","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

Abstract

Background: Sex and gender are related but distinct determinants of disease, treatment response, and research reproducibility whose consideration is increasingly required for research funding. Nevertheless, the quality of sex and gender reporting in neurological randomized controlled trials (RCTs) remains unknown. Methods: This ongoing study of RCTs associated with Food and Drug Administration neurological drug approvals aims to determine the frequency of accurate reporting of RCT participants’ sex and gender. Secondary outcomes include changes in reporting over time and RCT design characteristics. Results: Preliminary analysis included 145 RCTs (153,410 participants) associated with 77 medications approved in 1985-2023, most commonly for epilepsy (19%), migraine (16%), and multiple sclerosis (16%). Sixty-six RCTs (45.5%) used sex-related terms appropriately. Nine RCTs (6.2%) reported gender accurately. Fifty-three RCTs (37%) used sex- or gender-related terms interchangeably. There are no statistically significant differences in the proportions of studies reporting sex and/or gender accurately when comparing those published until versus after 2017. No RCT reported sex or gender collection methods, definitions of sex or gender, or including sex or gender minority participants. Conclusions: Preliminary results suggest shortcomings in reporting sex and, especially, gender accurately and inclusively among neurological drug RCTs and no significant improvement thereof in recent years.
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
P.024 美国食品和药物管理局批准的神经系统临床试验中的性别报告
背景:性别和性别是疾病、治疗反应和研究可重复性的相关但不同的决定因素,越来越多的研究资金需要考虑到这两个因素。然而,神经系统随机对照试验(RCT)中的性别报告质量仍不为人知。研究方法这项正在进行的研究是针对与美国食品药品管理局批准的神经系统药物相关的随机对照试验,旨在确定准确报告随机对照试验参与者性别的频率。次要结果包括随时间推移报告的变化以及 RCT 设计特征。结果:初步分析包括与 1985-2023 年间批准的 77 种药物相关的 145 项 RCT(153,410 名参与者),其中最常见的是治疗癫痫(19%)、偏头痛(16%)和多发性硬化(16%)的药物。66项研究性试验(45.5%)适当使用了与性别相关的术语。9 项研究性试验(6.2%)准确报告了性别。53 项研究性试验(37%)交替使用了与性或性别相关的术语。比较 2017 年之前和 2017 年之后发表的研究,准确报告性别和/或性别的研究比例在统计学上没有显著差异。没有一项研究报告了性别或性别收集方法、性别或性别的定义,或包括性别或性别少数的参与者。结论:初步结果表明,神经系统药物 RCT 在准确、全面地报告性别,尤其是性别方面存在不足,近年来也没有明显改善。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
自引率
0.00%
发文量
0
期刊最新文献
B.2 Time from symptom onset and number of health care encounters prior to diagnosis of cerebral venous thrombosis D.6 Neurological care and outcomes of pregnant patients with epilepsy in a Canadian tertiary care center (2014-2020) F.4 Anatomical assessment and comparative analysis of ventricular access points in pterional approach: a cadaveric study P.077 Reducing artifact during in bi-directional brain interfacing P.006 Barriers and risk factors for emergency room visits vs smartphone app use for migraine in Canada and the United States
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1