Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs
Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs
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DOI：
10.1016/j.jacc.2018.02.070
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发表时间：
2018-05-08
影响因子：
24
通讯作者：
Woodcock, Janet
中科院分区：
文献类型：
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作者：
Scott, Pamela E.;Unger, Ellis F.;Woodcock, Janet
背景关注存在妇女在心血管药物试验中代表性不足。结论作者试图检查妇女的参与和报告的安全性和有效性，按性别为关键性心血管疾病（CVD）试验提交给美国食品和药物管理局（FDA）支持上市申请。作者评估了2005年至2015年期间支持36种药物批准的试验中的女性登记情况。女性参与率的患病率校正估计值计算为试验参与者中女性的百分比除以疾病人群中女性的百分比（参与率与患病率比[PPR]），范围为0.8 - 1.2，反映了试验和疾病人群中女性的相似代表性。疗效和安全性的性别差异进行了assessed.Results的女性入组的比例范围从22%到81%（平均46%）。按疾病区域计算的PPR在房颤（0.8 - 1.1）、高血压（0.9）和肺动脉高压（1.4）的理想范围内或以上; PPR为
BACKGROUND Concerns exist that women are underrepresented in trials of cardiovascular medications.OBJECTIVES The authors sought to examine women's participation and the reported safety and efficacy by gender for pivotal cardiovascular disease (CVD) trials submitted to the U.S. Food and Drug Administration (FDA) supporting marketing applications.METHODS On the basis of publicly available FDA reviews, the authors assessed enrollment of women in trials supporting 36 drug approvals from 2005 to 2015. Prevalence-corrected estimates for the participation of women were calculated as the percentage of women among trial participants divided by the percentage of women in the disease population (participation to prevalence ratio [PPR]), with a range between 0.8 and 1.2 reflecting similar representation of women in the trial and disease population. Sex differences in efficacy and safety were assessed.RESULTS The proportion of women enrolled ranged from 22% to 81% (mean 46%). The calculated PPR by disease area was within or above the desirable range for atrial fibrillation (0.8 to 1.1), hypertension (0.9), and pulmonary arterial hypertension (1.4); PPR was