Strauss David G, Blinova Ksenia
Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA.
Division of Biomedical Physics, Office of Science of Engineering Laboratories, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD 20993, USA.
Trends Pharmacol Sci. 2017 Jan;38(1):4-7. doi: 10.1016/j.tips.2016.10.009. Epub 2016 Nov 19.
Clinical trials 'in a dish' involve testing medical therapies for safety or effectiveness in the laboratory with human tissue. This has become possible owing to recent biotechnology advances including induced pluripotent stem cells, organs-on-a-chip, and whole-genome sequencing. We provide here an overview of the landscape and highlight steps the FDA is taking to advance the science of clinical trials in a dish and to support the development and validation of new regulatory paradigms to assess drug safety using these new technologies.
“盘中”临床试验涉及在实验室中利用人体组织对医学疗法的安全性或有效性进行测试。由于包括诱导多能干细胞、芯片器官和全基因组测序在内的近期生物技术进展，这已成为可能。我们在此概述了这一领域的情况，并重点介绍了美国食品药品监督管理局（FDA）为推动“盘中”临床试验科学发展以及支持开发和验证使用这些新技术评估药物安全性的新监管范式所采取的步骤。
