End-to-End Drug Supply Management in Multicenter Trials

Abstract

As clinical trials are increasingly globalized with complex footprints over hundreds of sites worldwide, sponsors and contract research organizations constantly seek to make better and faster decisions on their investigational products, and drug supply planning must evolve to ensure efficient, effective supply chain for every study. This endeavor is challenging due to several characteristics of multi-center trials including randomization schemes for treatment arms, finite recruitment target (that is, across all sites, only a finite number of subjects need be satisfied) and uncertainty in recruitment, etc. In this paper, we provide an operational framework for end-to-end supply management for global trials. In particular, we utilize the Poisson-gamma model for patient recruitment since it facilitates accurate predictions of remaining time as well as the number of future recruits. Further, we can also derive closed-form formulas for parameters of inventory policies used in a multi-echelon system, which provides the foundation for analytically-based simulation. Finally, thorough numerical studies show insights into influencing factors to drug supply decisions.