Impact of phase zero trials (micro-dosing) in clinical trial research.

ABSTRACT

ABSTRACT Currently, pre-clinical trials using animal models, cell culture methods and bio-informatics takes up to 18 months and the typical development for investigational new drugs takes between ten to fifteen years and associated with high cost and low rate of approval. Phase 0 trials are attractive approach and in future would require only few preclinical studies, phase I trial and a reduced amount of the investigational new experimental drug on human. FDA supports the conduct of phase 0 trials in oncology related studies. The negative points pertaining to phase 0 trials is that the drug and dose is too small and reliable biomarkers are too thin on the ground despite great sum of money being spent to find and validate them. Phase 0 clinical trials can decrease the cost and time and could improve the process of drug development in future. In this review, we try to provide the recent developments and impact of phase zero trials in clinical trial research. Abbreviations FDA (Food and Drug AdministrationUSA), NOAEL (No Observed Adverse Effect Level)ADME(Absorption,Distribution,MetabolismandExcretion)