Driving Progress in Reducing Kit Wastage

Leonard Wee, VP, Global Supply Chain, Laboratories, ICON has over 23 years of experience in supply chain, with a focus on supply chain resiliency and risk mitigation, customer centric service offerings, E2E supply chain, global footprint optimisation, and cost and capital efficiencies. 

Regardless of industry, there is an imperative on all organisations to look at how they can operate more sustainably. For us here at ICON, this means looking at how we ourselves can operate more sustainably, but also how we can support the sponsors we work with to do the same.

Those of us involved in the day-to-day running of clinical trials would acknowledge that kit waste is a significant problem across the industry – an average of between 35-45% of kits are wasted, requiring costly waste management and kit destruction, filling landfills and contributing to environmental challenges.

Positively, there have been strides within the industry to redirect surplus kits and waste from landfills to under-resourced healthcare services. In addition to these worthwhile initiatives, there is ample opportunity, and fundamental reason, for us all to reduce the amount of waste created in the first place.

In this article, we’ll explore how shifting to more reliable kit forecasting, in tandem with efficient kit building practices, is a practical step that can be taken to reduce waste, cost and logistical requirements.

Kit Wastage Increasingly on the Agenda

Encouragingly, key players across the clinical development lifecycle are turning their attention to kit wastage, sponsors included. The reasons for this include post-covid supply chain stresses, but also the increased focus on corporate sustainability and environmental concerns as trial sizes and complexity increase.

Against this backdrop, sponsors are clear in their requirements for improved traceability and accountability. Experience shows us that sites could order as high as almost twice the number of kits required. This is not sustainable.

While sponsors want to send only what will be used, some sites prefer to have a certain inventory level, which can be prudent. Finding the balance that works on a case-by-case basis is key.

In looking at this challenge, we have implemented process steps to minimise over-ordering. These steps include such things as the requirement for large orders over a designated amount to be approved by the relevant project manager or clinical trial manager, thereby bringing heightened attention to the quantities, needs and inventories.

Simple procedural steps such as this do help in avoiding excess kit inventory and waste. In addition, more complex solutions such as the collection of historical datasets provide insight into enrolment and kit consumption patterns that can be used for better forecasting and future planning.

Proactive Strategies Required

Ultimately, however, reliable kit forecasting is where we need to get to in order to really shift the dial on wastage. This moves the strategy from reactive planning and execution to forecasting on a ‘just-in-time’ basis.

To support this shift, we’re now leveraging and further developing our new proprietary kit forecasting system. This system works by developing a new database of information to interrogate with data analytics to gain more intelligent data insights. Inputs to this system include consumption patterns, stock levels in addition to incorporating protocol schedules, indications, and enrolment rates to guide the ordering process.  Through using this approach, we, as the CRO (Clinical Research Organisation), can manage the kit ordering process to provide closer to ‘just-in-time’ kit deliveries, alleviating sites of this task.

One of the key benefits of this shift to a forecasting approach is that levels of sitting kit inventory are reduced, meaning kits are sitting idle for shorter periods, increasing the shelf life and longevity of these kits.

Homing in on High Waste

As with any new process, technology or system, the proof of success is in the results. Currently, we are piloting and developing our approach across multiple pharma partner programs. The results heretofore are encouraging – our pilot program is showing a 12-15% reduction in required kit budget.

Interestingly, we are also gaining insights into circumstances that pose higher risk for waste. A number of key insights have emerged:

• Certain studies will be at higher risk of waste based on enrolment strategies and protocol. For example, rolling enrolment means screening kits will be needed for a longer period, potentially longer than the inventory’s shelf life, which can contribute to waste.
• The critical period for high risk of kit waste is during recruitment. During the recruitment stage, the exact number of patients that will be recruited, and when, is not always known. The study team may have expectations of performance, but it is always variable.
• Greater communication and transparency between the site, sponsor and CRO helps to close the gap.

This communication point is important - as we continue to improve the feedback loop between sponsors, sites and CROs, the inputs are fine tuned to improve the accuracy of the data output.

The Role of Efficient Kit Building

Our view is that the operational efficiency of kit forecasting, coupled with efficient kit-building capacity, will become more important as we see more complex and larger studies increasingly become the norm. In addition to more kits, the kit requirements for such trials are also becoming more complex and customised.

Pre-building more components of kits allows for faster turnaround times compared to building each custom kit from scratch. Forecasting enables manufacturing to schedule capacity and deliver more efficiently. Pre-building kit components is part of a leaner operating model, enabling the just-in-time kit delivery approach based on forecasted levels, again reducing inventory on site shelves.

For these reasons, we’ve invested significantly in our kit building capabilities. With in-house production capabilities (producing a sizable portion of our annual volume) and stronger partnerships with our third-party kit vendors, we can drive a more agile supply chain, have closer control and oversight of the kit building and distribution process, leading to quicker turnaround times to meet study timelines.  

Sustainable Progress is Achievable

Mitigating kit waste requires a proactive approach. ICON’s kit forecasting system, while still in pilot stages, is generating crucial insights into kit consumption and waste patterns that will help us and the wider industry to curb this issue. We’re confident this knowledge will drive further improvements and refinements of the system.

‘Just-in-time’ production is not a new concept within manufacturing industries, but it hasn’t always been a model that is easy to implement given the level of customisation and day-to-day practicalities of clinical trials. With the support of novel data and technology capabilities and new processes working hand-in-hand with efficient production, we are confident in our progress to deliver much closer to ‘just-in-time’ for sites.

It’s an area where we think real sustainable progress and improved service levels can be achieved – progress that key stakeholders and sponsors are keen to see.