Clinical Trials in a Dish

• DOI: 10.1016/j.tips.2016.10.009
• Publication Date: 2016-11-19T08:45:21Z
• Authors: David G. Strauss; Ksenia Blinova
• Keywords: 0301 basic medicine; Clinical Trials as Topic; 0303 health sciences; 03 medical and health sciences; United States Food and Drug Administration; Induced Pluripotent Stem Cells; Humans; Precision Medicine; United States; 3. Good health

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.