title: Phase 0 clinical trials will overcome stagnation of anticancer drug development?
abstract: Recent guidance from the US Food and Drug Administration supports the conduct of a new type of exploratory clinical trials, commonly called phase 0 clinical trials, on the development of innovative anticancer agents, particularly targeted agents. Phase 0 clinical trials are controversial mainly because of the lack of clinical benefit to the participant patients. However, it was recognized that Phase 0 clinical trials can provide a platform to assessing the biological effects on the targets in tumoral human samples, evaluate biomarkers for drug effects and to generate essential human pharmacokinetics and pharmacodynamics data earlier in the drug development. It is expected that such trials will became a routine part of early-phase oncological drug development in the future.
authors.affiliation: INC Research, Prague, Czech Republic. Lmendoza@incresearch.com
authors.forename: L
authors.initials: L
authors.lastname: Mendoza
mesh_terms: D000970:Antineoplastic Agents; D002986:Clinical Trials as Topic / Q000379:methods; D015195:Drug Design; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000970:Antineoplastic Agents