背景:尽管临床试验中种族和民族代表性很重要,随着时间的推移,关于这些组房颤(AF)试验的纳入趋势的数据有限.
目的:本研究的目的是检查当代房颤临床试验的特征,并评估其与种族和民族的关系。
方法:我们对所有在ClinicalTrials.gov中注册的在受孕至2023年12月31日之间完成的房颤试验进行了系统搜索,并手动提取了种族/民族组成。我们按研究特点分层试验,包括影响因子,发布状态,资金来源,和位置。我们通过将非白人参与者的百分比除以非白人参与者在疾病人群中的百分比(PPR0.8-1.2表明比例代表)来计算参与患病率(PPR)。
结果:我们确定了277项完成的房颤试验,包括1,933,441名成年人。非白人的中位数比例为12%(IQR:6-27),121(43.7%)设备聚焦,184项(66.4%)由工业界资助。只有36.1%的试验报告了全面的种族信息。总的来说,非白人参与者的代表性不足(PPR=0.511;P<0.001),包括黑人(PPR=0.263)和西班牙裔(PPR=0.337)参与者。非白人参与者的比例在2000年至2023年之间没有显着变化(11%vs9%;P=0.343)。
结论:尽管意识更强,房颤临床试验中的种族/民族报告和非白种人组的代表性较差,并且随着时间的推移没有显著改善.这些发现需要额外的招募工作和新的招募政策,以确保在未来的AF临床试验中这些人口统计学亚组的充分代表。
BACKGROUND: Despite the importance of racial and ethnic representation in clinical trials, limited data exist regarding the enrollment trends of these groups in atrial fibrillation (AF) trials over time.
OBJECTIVE: The purpose of this study is to examine the characteristics of contemporary AF clinical trials and evaluate their association with
race and ethnicity over time.
METHODS: We performed a systematic search of all completed AF trials registered in ClinicalTrials.gov between conception to December 31, 2023 and manually extracted composition of
race/ethnicity. We stratified trials by study characteristics, including impact factor, publication status, funding source, and location. We calculated the participation prevalence ratio (PPR) by dividing the percentage of non-White participants by the percentage of non-White participants among the disease population (PPR 0.8-1.2 suggests proportional representation) over time.
RESULTS: We identified 277 completed AF trials encompassing a total of 1,933,441 adults, with a median proportion of non-White at 12% (IQR: 6-27), 121 (43.7%) device-focused, and 184 (66.4%) funded by industry. Only 36.1% of trials reported comprehensive
race information. Overall, non-White participants were underrepresented (PPR = 0.511; P < 0.001), including Black (PPR = 0.263) and Hispanic (PPR = 0.337) participants. The proportion of non-White participants did not change significantly between 2000 and 2023 (11% vs 9%; P = 0.343).
CONCLUSIONS: Despite greater awareness,
race/ethnicity reporting and representation of non-White groups in AF clinical trials are poor and have not improved significantly over time. These findings demand additional recruitment efforts and novel recruitment policies to ensure adequate representation of these demographic subgroups in future AF clinical trials.