Clinical Trial Simulation: Modeling and Practical Considerations

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 unique characteristics of multi-center trials including randomization schemes for multiple treatment arms, finite recruitment target (that is, across all sites, only a finite number of subjects need be satisfied) and uncertainty in recruitment rates, etc. Simulation has great potential for being the ideal tool which companies can utilize to make better decisions with considerations to both supply chain risks and costs. To achieve this goal, it is important to understand the specifics of clinical trial supply chains. Built upon this knowledge, our paper provides an advanced tutorial on modeling and practical considerations in clinical supply simulation.