IN PARTNERSHIP
optimize the trial design and IRT settings together to avoid static buffers for the comparator. This trial had an open-label comparator treatment arm. The solution involved two aspects. The visit schedule was adapted to guarantee a minimum screening period longer than the site shipping lead time. This was discussed and validated with the clinical team to guarantee a minimum screening period without impact for patients. Then the team implemented pre-randomization for the comparator treatment arm. This pre- randomization after screening assigns a treatment arm to patients before the first dispensing visit. This way, comparator kits were only sent to sites if patients were pre-randomized on that treatment arm. Optimizing the IRT settings alone would not have achieved the same results as an integrated approach of considering the IRT settings and the trial design early on. Comparator waste was reduced by 38% and costs by 23% (€19m). This overall solution was only possible because of the early optimization and the strong collaboration between the clinical supply and clinical operations teams. Concrete figures from the optimization scenarios eased the decision process.
Kit design optimization
The design of the kits for a trial is a decision that must be taken upfront and one that has a huge impact on the waste levels and costs of the trial. The impact of kit design is nearly impossible to assess using only a spreadsheet because of all the information that influences it. Optimal kit design cannot be identified in isolation from the full picture of the trial, including overall trial design, constraints and risk. N-SIDE clinical supply experts, using the Supply
App, collaborated with the Merck clinical supply team to assess the two possible kit designs: 1 vial per kit or 2 vials per kit. Both scenarios were modelled and optimized.
Packaging 1 vial per kit instead of 2 yielded significant savings. Total sourcing costs were reduced by 30%, representing €23m of cost savings. The total number of vials needed was reduced by 29%, and comparator drug waste was reduced by 18%.
Conclusions The results demonstrated in these case studies illustrate the impact of using optimization with the right processes and collaboration. Optimization is the starting point and a key success factor for safely driving down waste and sourcing costs.
Using a solution offering optimization over forecasting is important because: • Optimization is the only way to put the risk factor into the equation, providing a safe and robust strategy to supply your patients
• The supply overage needed to safely supply a trial is an output from the optimization, so guesswork is eliminated. Overage is never an input for optimization
• Optimization enables testing unlimited scenarios in an efficient way to truly investigate different possibilities during trial design and make fact-based decisions
• Everything can be optimized, including trial design, IRT, network, and country selection. Results provide factual support for decisions and can make the trial design much more supply friendly from the start.
Process plays an important role in having good quality data as inputs and reliable results. Some key elements to address in the process are roles and responsibilities, timing, and cross-team collaboration. It is important to define the roles and responsibilities of those involved. We have seen the benefit of having a dedicated team of in-house experts to drive optimization in the clinical supply department. The process also needs to define the time point to start optimization. Optimizing trials as soon as the protocol outline is available, allows the best results. Finally, it is essential to create processes that
drive collaboration between the teams, enabling the implementation of optimized results. In our daily work in clinical trial supply, we act as a bridge to connect information from up and downstream in the supply chain. Optimization and a strong process helps build effective collaboration across departments and with suppliers. We integrate the decisions of all teams – Clinical, Supply, IRT, Packaging and Distribution – for a safe and robust strategy. As part of this collaboration, the clinical and supply visions need to be aligned to make sure that the trials are feasible, patient- centric and also with less waste and cost. Finally, building this strong collaboration allows us to accelerate research. Saved budget and drugs can be reallocated to accelerated recruitments or advancing timelines of trials. This is a win not only for supply, clinical team, but for the patients waiting for safe and effective medications to be available.
For information, visit
lifesciences.n-side.com/ H1 Virtual Events: Review and Summary Handbook | 29
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