Toward the Definition of Efficacy and Safety Criteria for Advancing Gene Drive-Modified Mosquitoes to Field Testing
Toward the Definition of Efficacy and Safety Criteria for Advancing Gene Drive-Modified Mosquitoes to Field Testing
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DOI：
10.1089/vbz.2019.2606
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发表时间：
2020-03-09
影响因子：
2.1
通讯作者：
Nolan, Tony
中科院分区：
文献类型：
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作者：
James, Stephanie L.;Marshall, John M.;Nolan, Tony
目前正在开发含有基因驱动系统的蚊子，作为预防疟疾和其他蚊媒疾病传播的补充工具。与任何新工具一样，决策者和其他利益相关者在考虑测试和部署基因驱动改良蚊子产品的理由时，需要平衡风险（安全性）和收益（有效性）。开发人员将受益于判断研究性基因驱动产品是否符合进入田间试验的可接受标准的标准。这些标准可以被形式化为优选产品特性和目标产品概况，它们分别描述了产品类别和特定产品的期望属性。本报告总结了两个科学研讨会的讨论，旨在确定研究性基因驱动修饰蚊子产品必须满足的最低限度的有效性和安全性特征，以被认为是可行的，从包含测试转移到现场释放，以及支持首次现场释放申请所需的数据。
Mosquitoes containing gene drive systems are being developed as complementary tools to prevent transmission of malaria and other mosquito-borne diseases. As with any new tool, decision makers and other stakeholders will need to balance risks (safety) and benefits (efficacy) when considering the rationale for testing and deploying gene drive-modified mosquito products. Developers will benefit from standards for judging whether an investigational gene drive product meets acceptability criteria for advancing to field trials. Such standards may be formalized as preferred product characteristics and target product profiles, which describe the desired attributes of the product category and of a particular product, respectively. This report summarizes discussions from two scientific workshops aimed at identifying efficacy and safety characteristics that must be minimally met for an investigational gene drive-modified mosquito product to be deemed viable to move from contained testing to field release and the data that will be needed to support an application for first field release.