Integrated Planning and Optimization of Clinical Trial Supply Chain System with Risk Pooling

Clinical trials constitute an expensive part of the new drug development process, and thus, pharmaceutical companies are seeking ways to reduce this cost. The objective of clinical trial supply chain management is to ensure sufficient drugs for the volunteers while minimizing operational cost. Given the uncertainties in patient participation and completion of the treatment regimen, it is necessary to maintain some level of safety stock in the system, thus increasing drug inventories. However, drug packages leftover at the end of the trial must be disposed according to FDA regulations and thus constitute an important cost. In this paper, we use a simulation–optimization computational framework, which builds on our earlier work, to determine the appropriate level of pooled safety stock levels. The entire framework includes demand forecasting, planning and optimization, discrete event simulation, and an outer loop optimization. A case study is presented to demonstrate the utility of this proposed approach.