Despite the high costs associated with either too little drug supply (risking both patient and study outcomes) or too much drug supply (wasting excess or expired drug), as an industry, we have historically been hampered by our ability to accurately forecast how much drug we will need and when and where we will need it. It’s a difficult balance to achieve – providing adequate stocks throughout the entire trial while reducing waste – and often results in overstocking to avoid insufficient supply at a site.
However, as we implement and integrate more and better technology and software solutions, we have been able to use our experience with drug supply to get closer to knowing, or at least adjusting in real-time, how our supply chain should look. At Bioclinica, we’ve worked with our clients to help them reduce their drug waste – one client, Novo Nordisk, recently published an article in ORbit 30, the members magazine of Danish Operations Research Society (DORS), describing their efforts to streamline their trial supply (starting at 63% drug wastage in 2014). One component of their strategy, in addition to reviewing visit windows and packaging strategies, was to move from spreadsheet-based forecasting tools to using Bioclinica’s Trial Supply Optimization technology; this technology is purpose-built to enable pre-study and mid-study forecasting, simulation and optimization using initial assumptions followed by real-time study data on an ongoing basis as the trial progresses. As a result, they were able to reduce their waste to 45% in 2016 and are working toward a target of 35% in 2020. In another study, working closely with the sponsor clinical supply team and using the Bioclinica Trial Supply Optimization platform, we’ve also documented savings of $4.8 million and a reduction in the number of required kits by 14,810 in the client’s 72-month study involving 12,000 patients at 450 sites.
Dedicated simulation tools are a powerful alternative to spreadsheets or hybrid tools for determining and optimizing your trial supply. With these tools, you can quickly and easily create and compare supply scenarios against study objectives (e.g., schedule, cost, feasibility) to determine your optimum supply strategy. It is nearly impossible to run scenarios in a static spreadsheet, especially when you need to account for variability. More advanced tools integrate real-time data from your IRT system into the simulation tool, allowing you to validate initial assumptions and re-forecast based on how the trial is actually progressing – because, as we are all too aware, trials don’t always go to plan. Enrollment hiccups, missed patient visits and shipment delays can all interfere with our well-laid supply plans. Working from the initial forecast throughout the entire trial does not ensure an optimized supply chain.
It is also important to realize that even sophisticated tools are limited by the quality of the underlying data and settings used to determine which combinations are run (it is not possible to simulate all combinations – the trial would be delayed forever) to achieve an applicable forecast. This is when drug supply and optimization experts are useful. They can help manage the complexity – reviewing forecasts, highlighting risks and using the results to inform decisions. Finding a partner company that can provide this combination of software and service expertise can help fill a trial supply resource gap in your organization.