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首页> 外文期刊>Journal of women’s health >Tracking inclusion of women in clinical studies.
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Tracking inclusion of women in clinical studies.

机译:跟踪女性在临床研究中的纳入情况。

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摘要

Inclusion of women in clinical studies has been a challenge to the research community since the thalidomide disaster in the early 1960s. Concerns over potential exposure of pregnant women to products that would harm a developing fetus led to a 1977 Food and Drug Administration (FDA) policy and to research practices that excluded women of childbearing potential from many clinical studies in drug development. FDA reversed this policy beginning in 1993, following changes in the National Institutes of Health (NIH) policy and passage of legislation in 1990 that now requires inclusion of women in clinical studies funded by the NIH. There has been a measurable increase in the inclusion of women in clinical studies submitted to the FDA ever since.
机译:自1960年代初期沙利度胺灾难以来,将女性纳入临床研究一直是研究界面临的挑战。对孕妇可能危害胎儿发育的产品的潜在担忧导致了1977年美国食品和药物管理局(FDA)的政策,以及许多在药物开发的临床研究中都将有生育能力的妇女排除在外的研究实践。在美国国立卫生研究院(NIH)政策发生变化并于1990年通过立法(目前要求将女性纳入NIH资助的临床研究)之后,FDA从1993年开始撤销了该政策。从那以后,在提交给FDA的临床研究中,女性的参与率有了显着提高。

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