Introducing Sustainability into the Clinical Trial Supply Chain

Neta Bendelac

We understand that the shift to remote and hybrid healthcare service in the past few years has decreased a huge chunk of our carbon footprint. Sustainability is a conversation top of mind for the healthcare and biotechnology industries. Within these efforts, there has been a fair share of conversation around the sustainability of clinical trials. However, these conversations have zeroed in on the commercial supply chain, rather than providing a fair analysis of the sustainability of the clinical supply chain. In fact, in my own conversations with pharma companies and CROs, this issue is only barely seeing the light of day. There is an obvious awareness gap—one that needs to be filled in order to move the needle in our sustainability goals. In this article, I will touch on a few areas within clinical trials that are placing a burden on sustainability initiatives and then will dive into a few practical next steps that clinical supply chain operators can take to make their supply chains more sustainable and, ultimately, create a more eco-friendly, conscious way of bringing to market crucial medicines to those that need them.

The current state of sustainability

In a clinical supply chain, 70% of the budget is the distribution and almost 30% goes towards the packaging. The largest cost of clinical supply chain operations isn’t the drugs themselves, rather the means of getting these drugs, in a safe and efficient way, to the patients. This, in essence, is one of the key challenges to creating sustainable clinical trials and it has spurred a few notable advancements in the industry. For example, shippers that are used to transport medication from depots to clinical sites were once only used one time before disposal. In the last few years, shippers have been designed to be reusable. This was no small feat and now remains the industry standard, and it required operators to drastically reinvent the supply chain of their trials. Standing in the way of sustainable clinical trials are a few more roadblocks that I will break down below.

Sustainability gaps—where are we struggling?

Out-of-date forecasting

It’s difficult to predict how many shipments are needed after the initial shipment, as frequent shipments are essential for larger studies. The key with these constantly shifting, dynamic trials, however, is to make them smart. But this is unfortunately not the reality of today’s constantly shifting, dynamic trials. In most trials, an initial quantity is shipped, then additional shipments are generated based on updated demands. This gap between the shipping frequency and the actual needed inventory level increases the carbon footprint andwaste produced in a clinical trial. Legacy tools used to forecast user decisions and demand are trailing behind actual trial operations.

Lack of tools to measure

When we talk about sustainability, we must take a closer look at how it is being measured. Although Direct-to-Patient (DtP) trials provide a host of benefits and are shifting the direction to a more patient-centric model, DtPs are also contributing to hefty carbon consumption, given the drugs and supplies that need to be individually shipped to disparate locations. However, if we take a step back, we know that the overall reduction of patient visits to a central location is also reducing a considerable amount of waste and carbon consumption. So, we are reducing the waste at the site level but taking up a much larger carbon footprint in total. As you can see, there is a calculation that needs to be made to shine some light into these muddy waters, one that considers the total carbon footprint of a DtP or DCT trial. One tool that has attempted to measure it, partly, is the Sustainable Healthcare Coalition’s ‘Eco-Design Tool.’ Announced last year, it set out with a goal of measuring the carbon footprint of clinical trials. Although it is a great effort to measure one aspect of operations, we face the same issue I mentioned earlier. This tool, and similar tools in the industry, track the footprint of the commercial supply chain, rather than the clinical supply chain.

Increasing ancillary waste

One of the biggest factors in creating more sustainable clinical trials is managing and reducing waste, a challenge not easy to achieve given the sensitivity of the supplies at hand. Ancillary waste contributes a significant burden on overall waste. Given how inexpensive ancillaries (such as syringes, needles, and infusion kits, etc.) are, operators will usually order an overwhelming amount that is above and beyond what is needed. When tackling the issue of waste, more attention is paid to managing the expensive supplies (such as drugs, centrifuges, and fridges), which absolutely makes sense from a financial standpoint. But more and more CROs are adopting technologies, such as Randomization and Trial Supply Management (RTSM) and Interactive Response Time (IRT) solutions, to manage their ancillaries, as well. Of course, the priority is the more critical supplies, but the waste being generated from ancillaries plays a huge role in our conversations around eco-friendly trials.

Drug transportation

With the exception of certain drugs, such as biosimilar drugs, that are cheap to manufacture, in many cases the process of preparing a drug for trial outweighs the cost of the drug itself. The manufacturing and packaging costs in Phase I of trials often produce the most waste, given the simple cost of doing business. Once you transition to the later phases, managing waste and cost becomes much more critical. It’s here that advanced RTSM and IRT technologies hold the most promise. As volumes rise, the need to accurately predict the amount of patient kits becomes a more serious responsibility. However, supply chain managers are often left with the hefty task of manually and constantly monitoring this process, leading to inevitable waste and unnecessary dollars spent. It’s important to note that there will always be an element of waste in clinical trials. The goal isn’t to eliminate total waste, but to find a balance between patient outcomes and sustainable research practices.

Four steps towards more sustainable trials

Following are four practical steps and solutions clinical trial operators can take to create more sustainable, eco-friendly supply chains.

Advanced forecasting

Technologies brought in to help with clinical trial supply chains need to be as dynamic as the trials they are running on. The role of technology cannot be overstated, especially as decentralized trials become more complex and produce an increasingly overwhelming amount of data points. Modern, smart forecasting engines are key advancements that can help users decide how they manage their supplies in a dynamic way. It will also allow them to make predictions about new patients and ensure optimal management of inventory to reduce waste.

Intentional kit design

Before kits leave the central depot, their initial design is key to reducing waste, as this will dictate the waste per patient. The packaging process involves: primary packaging and labeling, secondary packaging and clinical labels for all countries participating, as well as shipping materials that are directly influenced by the dimensions chosen.

Questions that should be asked include:

• What is the product’s profile?
• What are the product’s constraints, such as its expiration date or temperature requirements?
• Am I defining the right quantity in relation to the correct dosage, based on each specific patient (fixed dosing vs. parameter based, etc.)?
• How will the product be used (at home, at work, etc.)
• Who is the population?

The way we design kits should be intentional and strategically planned to meet the needs of different patients in different locations.

Improved mitigation solutions

Temperature excursions can disqualify and/or destroy an entire shipment of patient kits. Advanced technology that can manage and mitigate these risks is necessary, along with a holistic knowledge of the common types of risks each distinct trial may face. This will involve finding the right monitoring tools that can detect and report changes in real time. It will also require more careful planning of where these mitigation tools are implemented in the distribution of supplies and in the supply chain of clinical trials themselves.

The issue of sustainability in clinical trials is a multifaceted one that must be addressed from a few different angles. Overall, it’s critical to note the individual needs and constraints among the different phases. When we begin to enter Phases III and IV of a clinical trial, the impact of advanced technologies such as RTSM will hold a heavier burden of responsibility. Ultimately, sustainability in clinical trials winds down to how we are responsibly managing the resources and waste that pass through our supply chains. As mentioned earlier, it’s impossible to reduce waste completely, but we should, as an industry, be taking steps towards more sustainable, eco-friendly ways of advancing science.

Neta Bendelac, senior director of strategy, 4G Clinical