IN PARTNERSHIP
How to efficiently reduce sourcing costs and drug waste
As Rita Meirinhos, senior consultant for life sciences at N-SIDE, and Fan Feng, associate director clinical trial supply at Merck Healthcare KGaA, explain, a collaborative approach combines optimization and processes.
recruitments and trial timelines. Finding opportunities to reduce drug waste and cost without incurring supply chain risk has become more challenging. Past ways of working to manage the clinical supply chain, such as using spreadsheets as the main planning tool, no longer fit the purpose of safely and robustly supplying these trials. To reduce sourcing costs and drug waste
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safely, the right solution needs to be used that accounts for risk proactively, supported by the right processes and efficient collaboration.
Drivers of drug waste
Ask most clinical supply managers the number-one source of drug waste in clinical trials, and they will tell you “unexpected events”. Planning for the unexpected is the name of the game in clinical trial supply, meaning there always needs to be a buffer in the supply chain to manage uncertainty. Manually defining overages, site and depot buffers, and overestimating demands to be safe, are some of the main causes of avoidable waste. However, there are other important drivers of drug waste that are less often identified as critical. Trial and supply chain design is often overlooked but is another main driver of drug waste, which needs to be addressed early on. Optimizing trial design needs a robust solution, processes and efficient collaboration. Using optimization as early as the first protocol outline will yield the maximum benefit. This is
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t’s no secret that the complexity of trials has been increasing dramatically, along with the added pressure towards faster
because optimization enables the assessment of the trial design’s impact on the supply chain. By testing scenarios, supply and clinical teams can easily assess which parts of the trial design have the highest impact on supply budgets and drug waste, allowing data-driven decisions to help design both protocol and supply chain. Involving the supply team at the earliest
stage in the trial design helps prevent supply inefficiencies and waste. Depending on the characteristics of the trial, there are many areas that can be optimized at trial design, including: • kit design • visit intervals and windows • IRT configuration • country selection/feasibility • direct to patient • stratification • unscheduled visits • screening period • distribution network
Innovative solutions to reduce waste and costs N-SIDE clinical supply experts and the Merck clinical supply team collaborated to optimize the protocol design for a trial within an important oncological clinical programme. The goal was to reduce drug waste and sourcing costs. The drug supply strategy needed to be safe and robust to ensure 100% patient service levels. The challenges involved were numerous: an
expensive comparator with a short shelf life, a complex distribution network, and a four-year treatment duration. N-SIDE experts identified the opportunity to
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