However, the new guideline suggests an investigational new drug filing system, in which, the clinical trial may be initiated 60 working days after filing the application if no negative or questioned review opinions are received.
SummaryIn the context of clinical trials where one of several doses or treatments is selected in a phase II study to be examined further in a phase III study, we develop a formulation for the combination of the overall information obtained from such studies, which mimics the logic followed in actual drug development.
In phase II studies of targeted agents, multiple- versus single-institution participation, positive phase II trial, pharmaceutical company-based trials, and shorter time period between publication of phase II to phase III trial were independent predictive factors of success in a phase III trial.
