DIA 2018 Global Annual Meeting

Under PDUFA VI, FDA committed to developing two pilot programs. The goal of the Complex Innovative Designs (CID) pilot is to facilitate the advancement and use of complex, Bayesian, and other novel clinical trial designs and will focus on highly innovative trial designs for which analytically derived properties (e.g., Type I error) may not be feasible, and simulations are necessary to determine trial operating characteristics. The Model-Informed Drug Development (MIDD) pilot is intended to facilitate the development and application of exposure-based and biological models derived from preclinical and clinical data sources. Drug development programs where clinical data are limited such that integration across non-traditional sources may be needed as well as programs for which MIDD can assess uncertainties about dosing, duration, patient selection, and other factors will be considered for the pilot. In this session, we will discuss the importance of these two PDUFA VI pilot programs, explain the agency’s goals for these programs, and highlight the difference between these two pilot programs.
Three speakers from FDA are invited to share their expectations and visions for these programs which launch in 2018.