Advancing Ethics and Policy for Healthy-Volunteer Research through a Model-Organism Framework.
Advancing Ethics and Policy for Healthy-Volunteer Research through a Model-Organism Framework.
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DOI：
10.1002/eahr.500001
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发表时间：
2019-01-01
影响因子：
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通讯作者：
Walker, Rebecca L
中科院分区：
文献类型：
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作者：
Fisher, Jill A;Walker, Rebecca L
非人类动物研究和I期健康志愿者临床试验都是测试研究药物安全性的关键组成部分，作为新药开发的一部分。此外，这些类型的研究具有重要的结构特征，因为两者都是在封闭的环境中进行的，而且都使用与目标人口不同的主题。通过动员一个模型生物体框架的第一阶段试验，我们采用的概念和机制，典型的动物研究，以查询人类受试者的伦理和政策框架的差距。通过将这两个研究领域结合在一起，我们的目标是说明模型生物体框架如何在试验期间提高健康志愿者的福利，改善研究监督，并更严格地评估当前I期试验的科学价值。
Nonhuman animal research and phase I healthy-volunteer clinical trials are both critical components of testing the safety of investigational drugs as part of the development of new pharmaceuticals. In addition, these types of research share important structural features, as both take place in confinement and both use subjects that are dissimilar to the target population. By mobilizing a model-organism framework for phase I trials, we employ concepts and mechanisms typical to animal research to query gaps in the human subjects ethics and policy framework. By bringing these two research worlds together, we aim to illustrate how the model-organism framework can enhance healthy volunteers' welfare during trials, improve research oversight, and more critically assess the science value of current phase I trials.