Wastage in clinical trials is accepted as the norm. Large buffers are added to protect the trial, to ensure that there is enough drug product when and where the patients need it, and to ensure that the trial runs to completion. But adding estimated buffers at different stages of manufacturing and clinical trial supply is an inaccurate way of managing risk and can actually lead to waste and missed opportunities.
There is another way. It involves breaking down silos, gaining a deeper understanding of, and bringing visibility to, the whole clinical trial supply chain to achieve cross-department alignment. It means that trials can be planned accurately and more efficiently. It frees up manufacturing time and enables new trials to be started faster. The solution: end-to-end clinical supply chain optimization.
From bottlenecks to buffers
Clinical trial wastage rates are currently averaging between 55-75% at the industry level. As we meet the demands of a growing global population and break the boundaries of research to fight disease, the burden on the clinical trial process grows. Drugs need to be produced faster and there is pressure on pharmaceuticals to deliver more cost-effective solutions.
But as the trial complexity grows, the wastage grows too, and the main culprit is the introduction of safety buffers throughout the supply chain to account for uncertainty. They’re added at the site level, at depots, in the packaging process, at sourcing and during the manufacturing of the drug substance (DS) and drug product (DP). No part of the supply chain can afford to be the bottleneck. Each part needs to ensure that they have enough supply to meet the demands of their process and, due to the lack of data down and upstream of their function, they are largely working within uncertain assumptions.
When the DP or DS demand is overcalculated, the clinical trial process is slowed and the number of trials that can run in parallel is limited. This results in manufacturers working harder and overproducing in order to meet the needs of each trial.
With growing research in biotech products, we can no longer afford these overproductions.
The success of a trial is determined by its data
The remedy comes in understanding the clinical supply chain fully. This involves connecting data silos, enabling greater sharing and feedback of information, leveraging real-time clinical trial data and producing an accurate simulation of the entire clinical supply chain.
This is end-to-end optimization and it’s more powerful than you might think.
The first step is providing a single source of truth, shared by the whole supply chain, from manufacturing to the clinical trial supply and clinical operations. Imagine an easy to use system that all stakeholders can feed into and draw data from. Not only does it allow transparent information exchange, but it also provides an overview of the entire production planning and trial pipeline.
The bottlenecks, and the origins of drug wastage, can be accurately identified, allowing stakeholders to find solutions to tackle these problems on a global level.
On the manufacturing side, decisions can be optimized in regards to lot-to-lot and lot-to-demand allocation, lot sizing and timing, as well as clinical trial-specific constraints like the drug stability plan. This typically reduces the DS to DP and DP to IMP waste by 10-20%.
On the clinical trial supply side, protocols can be designed to be more supply-friendly, while at the same time ensuring patient and site centricity. For example, the kit design can be optimized alongside the vendor selection, the IRT configuration, network and country selection. This can lead to a clinical trial specific drug reduction of 20-60%.
In turn, this approach leads to the generation of feedback loops. Even though trials run in different geographical areas at different times, or using different drug doses and designs, they are still linked inextricably by the drug substance that they rely on. If one trial consumes more drug, less of it can be allocated to other projects. With this new approach, separate trials sharing the same DS become connected as one big project to optimize.
When you see the accurate picture of this global project and its integrated parts, you can start to make informed decisions for drug allocation. You can earn more flexibility and accelerate the research process, reducing inefficiencies at every step in the chain.
Through open dialogue, everyone benefits
On a practical level, reducing wastage means that the whole clinical research process can be accelerated. New sites can be opened sooner than planned and additional depots can be established to accelerate the trial. Enrolment levels can be increased due to higher drug availability. Trial starting dates can be brought forward, giving more patients access to the drug earlier. Excess drug product and budget can be reallocated to start additional clinical trials for different indications that were initially not budgeted for. Movement into phases 2, 2b and 3 is accelerated by this ripple effect, and the drug finds a faster route to market. Manufacturing resources can then be re-allocated to new projects earlier.
In adopting the principles of end-to-end optimization, no element of the clinical trial supply chain is left untouched and every stage benefits.
N-SIDE Suite for Clinical Trials
Through our N-SIDE Suite for Clinical Trials, we use an app-based platform to enable data sharing at every stage of the supply chain.
With the N-SIDE Production App, we help clients recognize bottlenecks, identify allocation constraints and enable risk-based decision-making to solve issues. For example, optimizing drug substance to product allocation could lead to solutions such as unfreezing smaller batches of drug substances to extend shelf lives. This approach allows the trial to meet real-time needs and move towards smaller manufacturing lots. Trials now have the right amount of drug with the required shelf life at the right time, rather than drug products expiring unused.
Scenarios can be modeled to check viability and predict the impact of decisions on wastage rates, such as lot pooling, lot sizes, outsourcing, stability planning and investment in new resources.
Our N-SIDE Supply App helps clinical trial supply managers understand the demands of the trial so the overall trial design can be optimized ensuring patient service levels and cost-efficiency. The trial becomes as supply-friendly as possible while keeping the focus on patient centricity. Overall, the trial is allowed to evolve with the flexibility that it requires and with the right drug allocation available at the right time. Real-time data is used to monitor and re-evaluate the supply strategy as time passes, ensuring an all-time optimal drug supply and risk management.
And, of course, every learning and change is fed back into the N-SIDE Production App to adjust manufacturing and allocation flows accordingly.
The evolution of the DP demand can be modeled for all clinical trials that share the same DS and areas of peak and low demand can be easily identified. An overall picture can be formed quickly, showing how the DS will convert to DP over time and how and where it will be allocated. This leads to accurate and granular cost analysis for each drug category.
Gaining real-time insight into the trial progression gives program and study managers the data they need to make educated decisions. Stakeholders at every part of the trial can feed in improvement suggestions as the trial advances and a culture of collaboration is formed.
Are we ready to change?
The focus of each and every clinical trial is to get drugs to market in the safest, most cost-effective and expeditious way possible. For years, we have relied on a model that evolved out of necessity and is dependent on workarounds and built-in wastage. We’ve had to do it to guarantee the success of the trial, but now there is a better way.
By using software to optimize, while enabling a single source of truth, driving collaboration and sharing of data between stakeholders, and providing an accurate model of the clinical trial supply chain, we will revolutionize clinical research. Drug wastage will drop dramatically, trial costs will reduce, patients will have access to trials earlier, drugs will be market-ready quicker and new drugs can find their way to trial sooner.
It’s available to us now. It requires a new mindset, but the industry is ready for this change.
Learn more about N-SIDE Suite for Clinical Trials!