title: Clinical Trials in a Dish.
abstract: 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.
authors.affiliation: 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. Electronic address: David.Strauss@fda.hhs.gov.
authors.forename: David G
authors.initials: DG
authors.lastname: Strauss
authors.affiliation: 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.
authors.forename: Ksenia
authors.initials: K
authors.lastname: Blinova
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D057026:Induced Pluripotent Stem Cells / Q000166:cytology / Q000187:drug effects; D057285:Precision Medicine; D014481:United States; D014486:United States Food and Drug Administration