Ethical issues for late-stage trials of multipurpose prevention technologies for HIV and pregnancy.

Ethical issues for late-stage trials of multipurpose prevention technologies for HIV and pregnancy.
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DOI:
10.1016/j.ijgo.2014.07.012
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发表时间:
2014-11
影响因子:
3.8
通讯作者:
Macklin, Ruth
Macklin, Ruth
中科院分区:
医学4区
文献类型:
--
作者:
Cohen, Jessica A.;Mastroianni, Anna C.;Macklin, Ruth

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旨在同时预防怀孕和艾滋病毒的多用途预防技术可以提供迫切需要的工具,以满足全世界妇女未得到满足的性健康和生殖健康需求。鉴于需要同时证明单一产品对艾滋病毒和避孕适应症的疗效,后期临床试验将是复杂的。目前,HIV和妊娠预防试验具有独特的设计特征,需要在MPT试验中进行协调。本文确定了与这项研究独特相关的几个伦理问题,这些问题将受益于未来的审议和指导,以确保这项具有全球重要性的研究能够有效和迅速地进行。
Multipurpose prevention technologies (MPTs) designed to simultaneously prevent pregnancy and HIV could provide urgently needed tools to address unmet sexual and reproductive health needs of women worldwide. Late-stage clinical trials will be complex given the need to demonstrate efficacy for HIV and contraceptive indications simultaneously from a single product. Currently, HIV and pregnancy prevention trials have distinctive design features that will need to be reconciled in MPT trials. This article identifies several ethical issues uniquely associated with this research that will benefit from future deliberation and guidance to ensure that this globally important research can proceed efficiently and expeditiously.
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