Fisher Jill A, Walker Rebecca L
Associate professor in the Department of Social Medicine and the Center for Bioethics at the University of North Carolina at Chapel Hill.
Professor in the Department of Social Medicine and the Center for Bioethics at the University of North Carolina at Chapel Hill.
Ethics Hum Res. 2019 Jan;41(1):4-14. doi: 10.1002/eahr.500001.
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.
非人类动物研究和I期健康志愿者临床试验都是作为新药物研发一部分来测试研究性药物安全性的关键组成部分。此外，这些类型的研究具有重要的结构特征，因为它们都是在受限环境中进行，并且都使用与目标人群不同的受试者。通过为I期试验调动一个模式生物框架，我们运用动物研究中典型的概念和机制来探究人类受试者伦理和政策框架中的差距。通过将这两个研究领域结合在一起，我们旨在说明模式生物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，以及更关键地评估当前I期试验的科学价值。
