Simulation-based Optimization Approach to Clinical Trial Supply Chain Management

摘要

The development activities required to bring a new drug to market involve considerablernexpense ($1+ Billion) and can take in excess of ten years. Clinical trials constitute arncritically important and very expensive part of this development process as itrnencompasses producing, distributing and administering the candidate therapy tornvolunteer patients located in different geographic zones. A number of differentrnapproaches are being pursued to reduce clinical trial costs, including innovations in trialrnorganization and patient pool selection. In this work, we focus our attention onrnimproved management of the supply chain which provides the dosage required by thernclinical sites. A simulation-based optimization approach is presented, which includesrnpatient demand forecasting, mathematical programming based planning, and discreternevent simulation. The objective is to enhance the robustness of the supply chain underrndifferent sources of uncertainties. A case study is reported which demonstrates thernapplication of the proposed approach.