Department of Medicine, Section of General Internal Medicine, Women's Health Unit, Boston University School of Medicine, Boston, MA, USA.
Department of Health Law, Policy and Management, Boston University School of Public Health, Boston, MA, USA.
Addiction. 2022 Oct;117(10):2583-2590. doi: 10.1111/add.15842. Epub 2022 Feb 27.
Women have historically been under-represented in clinical research, but the extent to which this is true for substance use disorder (SUD) trials is unknown. We aimed to determine the ratio of female:male participation in clinical trials for SUDs and describe the reporting of sex-specific outcomes from 2010 to 2019.
A retrospective cohort review of clinical trials involving people with SUD.
United States.
Clinical trials including people with SUD registered in clinicaltrials.gov and completed between 1 January 2010 and 31 December 2019 were reviewed. Trials were excluded if they had < 30 participants, focused on SUD prevention, were conducted outside the United States and/or did not report data on participant sex or gender.
The following were extracted for each trial: primary outcome, number of participants enrolled, analytical sample size, percentage of participants who were female, inclusion of transgender participants, whether sex-based analyses were performed, funding source, type of SUD and type of intervention. Relative representation in trials was examined using the female:male ratio, reported using median ratios and by year of trial completion. The proportion of females participating was adjusted using the underlying disease prevalence among females using National Survey on Drug Use and Health data.
A total of 316 trials met inclusion criteria: 274 were mixed-sex, 12 enrolled only males and 30 only females. In 274 mixed-sex trials, 40% of 57 544 participants were female. Only 22 trials (8%) reported any sex-specific analyses; four studies (1.5%) reported inclusion of transgender participants. Females represented 35% of participants in trials targeting illicit drug use disorder, 52% in nicotine use disorder and 29% in alcohol use disorder. Accounting for underlying disease prevalence revealed that women had the lowest relative enrollment in alcohol use disorder trials (median participation to prevalence ratio in 2017: 0.58; 95% confidence interval: 0.13, 0.91).
A review of 316 US clinical trials for alcohol, nicotine and illicit substance use disorders completed between 2010 and 2019 showed that females were enrolled at lower rates than males overall. Only 8% of the trials reviewed reported sex-specific analyses and 1.5% reported transgender participants.
女性在临床研究中历来代表性不足，但在物质使用障碍（SUD）试验中这一情况的严重程度尚不清楚。我们旨在确定 SUD 临床试验中女性与男性参与者的比例，并描述 2010 年至 2019 年期间报告的特定性别结局。
一项涉及 SUD 患者的临床试验的回顾性队列研究。
美国。
对 2010 年 1 月 1 日至 2019 年 12 月 31 日期间在美国完成的、在美国临床研究注册中心注册的 SUD 患者的临床试验进行了回顾。如果试验参与者少于 30 人、重点是 SUD 预防、在美国以外进行或未报告参与者性别，则排除试验。
为每个试验提取以下内容：主要结局、参与者人数、分析样本量、女性参与者比例、跨性别参与者的纳入情况、是否进行基于性别的分析、资金来源、SUD 类型和干预类型。使用女性：男性比例来检查试验中的相对代表性，使用中位数比值和试验完成年份报告。使用国家药物使用和健康调查数据中女性的基础疾病患病率来调整女性参与比例。
共有 316 项试验符合纳入标准：274 项为混合性别，12 项仅纳入男性，30 项仅纳入女性。在 274 项混合性别试验中，57544 名参与者中有 40%为女性。仅有 22 项试验（8%）报告了任何特定性别的分析；四项研究（1.5%）报告了跨性别参与者的纳入情况。在针对非法药物使用障碍的试验中，女性占参与者的 35%，在尼古丁使用障碍中占 52%，在酒精使用障碍中占 29%。考虑到基础疾病的患病率，发现在酒精使用障碍试验中，女性的相对参与率最低（2017 年的中位数参与到患病率比：0.58；95%置信区间：0.13，0.91）。
对 2010 年至 2019 年期间完成的针对酒精、尼古丁和非法物质使用障碍的 316 项美国临床试验进行的回顾显示，总体而言，女性的参与率低于男性。只有 8%的试验报告了特定性别的分析，1.5%的试验报告了跨性别参与者。
