Women's involvement in clinical trials: historical perspective and future implications.
Women's involvement in clinical trials: historical perspective and future implications.
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DOI：
10.18549/pharmpract.2016.01.708
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发表时间：
2016-01
期刊：
影响因子：
--
通讯作者：
Mager NA
中科院分区：
文献类型：
--
作者：
Liu KA;Mager NA
在临床决策中考虑男性和女性之间的差异至关重要。然而，近几十年来人们认识到，临床试验并不总是充分招募女性或分析数据中的性别差异。由于这些缺陷阻碍了了解女性对药物反应的进展，美国各机构致力于将女性纳入临床试验，并对临床试验中的特定性别数据进行适当分析。本综述概述了女性参与处方药临床试验的历史和进展，并提出了研究人员、临床医生和院士对此问题的考虑。
The importance of considering the differences between the male and female sex in clinical decision-making is crucial. However, it has been acknowledged in recent decades that clinical trials have not always adequately enrolled women or analyzed sex-specific differences in the data. As these deficiencies have hindered the progress of understanding women’s response to medications, agencies in the United States have worked towards the inclusion of women in clinical trials and appropriate analysis of sex-specific data from clinical trials. This review outlines the history and progress of women’s inclusion in clinical trials for prescription drugs and presents considerations for researchers, clinicians, and academicians on this issue.