Just-In-Time labeling: Short-term fix or long-term fixture for clinical trials?

A widely recognized impact of the pandemic on the clinical trials landscape has been the increasing use of JIT methods for clinical trial supply and distribution, with many organizations compelled to find new ways of delivering for their patients as they faced closures to trial sites and multiple COVID restrictions.  

The big question now though is whether this trend will be sustained. Are we witnessing a fundamental turning point in how clinical trials operate, or merely a temporary detour from an established status quo?   

In this blog, I wanted to review some of the factors that suggest the focus on JIT or on-demand methods is more than just an emergency response to the pandemic, but integral to the way the industry remodels its production processes for the future – key to this, as we’ll see, is the adoption of a global labeling system to ensure compliance and deliver the efficiency, speed and agility gains that are at the heart of JIT’s appeal.  

An imperative to act 

Let’s start by looking at what’s been driving interest in JIT methods. High levels of waste and inefficiency are long-established challenges for clinical trials organizations. The dire implications of any failure in supply for patients have traditionally meant that organizations have tended to err on the side of over-supplying their trial sites. Indeed, it is estimated that, in a typical trial, for every 700 doses of medicine distributed, around 500 are never used – a wastage rate of around 60-70 percent.  

While the desire to reduce waste and inefficiency has always been there, two factors have now created an overwhelming imperative to act. The first, as already mentioned, is the stark logistical challenges posed by the pandemic, which left CTOs with little option but to explore new ways of supplying patients through decentralized methods. The second is the rise of next-generation medicine and their associated costs: with a year’s course of treatment for biologics trials potentially costing upwards of $500,000 when the cost of comparator medicines is taken into account, the financial case for reducing waste is far greater than it has ever been before.  

Tackling root causes 

The attraction provided by JIT methods – when supported by a global labeling solution – is that they can address many of the root causes of excessive waste and inefficiency within a clinical trial process.  

First, JIT techniques eradicate a lot of the logistical costs of dealing with expired products or having to relabel and reallocate products across multiple sites. Whereas CTOs previously had to rely on accurate demand forecasting – and a fair wind – in managing stock levels across sites, JIT can now offer a more precise and timely way of organizing product inventories based on local demand. 

Second, they reduce the potential cost of errors. A simple barcode or print quality failure on kits dispatched to multiple locations might create several weeks’ delay to the trial using conventional methods – it wouldn’t be out of the ordinary for this to carry an opportunity cost of up to $40m in lost revenues.  A JIT approach, backed by a global labeling solution, reduces the risk of introducing manual errors during production and ensures the small-batch printing of packaging labels can be delivered in a time and cost-effective way. 

Third, the control and agility provided by JIT methods can help alleviate concerns from sponsor organizations about supply chain complexities. The increased role of outsourcing complicates the supply chain and carries the potential for delay in trials using traditional manufacturing and logistics models. Sponsors are increasingly looking for reassurance, via a more consolidated end-to-end solution, and are asking more exacting questions about this in their negotiations.  

Finally, the drive towards patient-centricity in clinical trials has added an additional component to planning and production as sponsors demand more convenient and accessible ways of distributing products to patients. JIT opens new possibilities for connecting with and supporting the patient in a more sophisticated and personalized way. 

Conclusion 

Yet, taking all of this in the round, perhaps the most compelling reason why JIT models are here to stay is that it’s now a proven concept. The pandemic, out of necessity, has swept away much of the skepticism and inertia that have stopped organizations from embracing it. Embedded in real-world practice, JIT has shown it can deliver.   

It’s this proof of value that breeds confidence in JIT or on-demand as a viable way forward – and it’s why we believe it’s highly likely to remain an integral part of how clinical trials deliver for patients in the future.