Clinical trials require the holistic management of a lot of moving parts and increasingly so, as more and more clinical trials go global. It is no wonder then that approximately 70% of these trials are outsourced to Contract Research Organisations (CROs) to optimise every stage of the process.
If there is one thing that indicates that a clinical trial is not running optimally, it is waste. Wasted time, wasted research, and wasted medicine also mean wasted money, an immediate deterrent for potential shareholders and investors.
According to Ian Hoban, business development director for Healthcare and Pharma Services company Aposave: “Anecdotally, we’re told between 20-25% of drugs are wasted in comparative clinical trials. We also know that COVID-19 has impacted the amount of destruction of medicines because many projects have been stalled, meaning that inventory that’s been built in advance of the delay now has compromised expiry dates.”
While the global pandemic has had the most notable effect on the industry, drastically changing the way that trials operate, there have always been a myriad of factors that trial sponsors have needed to consider in order to optimise their inventory and reduce the risk of waste.
“There’s often a disconnect between what was initially thought to be needed and what is actually needed at any given time during the life of the clinical trial,” Hoban explains. “It’s not just about avoiding destruction of surplus/expired stock. On the flip side, if companies source insufficient stock to allow for risks at certain pressure points in the supply chain, lack of provision of extra contingency stock can easily lead to insufficient stock availability to treat some of the patients that have been recruited.
“So, it’s a fine balancing act to ensure inventory levels are optimised to avoid both excessive surplus stock build-up and potential stock outages which need to be reviewed dynamically. Medicines sourced for clinical trials have got a finite shelf life. So, if something like a three-month delay to start the trial occurs, the longer-term viability of the stock will be compromised depending on the profile of the comparator being sourced.
“Some drugs have a 36-month shelf life, so you can confidently buy all the inventory you need for a two year study and you are probably not going to have any issues. But with other comparators, even if you buy direct from the manufacturer, you may only get a 15-month shelf life at best. So, a ‘one size fits all’ approach should never be taken.”
Several factors can delay trials such as the global footprint of the trial, issues with recruitment, and obstacles with regulations. Often, the more regions that are involved in a single trial, the higher the number of interfaces. This means that trials will invest in more surplus stock to cover the risk for each of those potential hurdles. This not only increases the chance of wasted stock, but also makes visibility more complicated if stock is being stored in multiple locations.
Aposave can help clinical trial sponsors to optimise inventory management and reduce the risk of waste with its bespoke trial planning solutions.
“It’s the nature of a holistic approach to the whole clinical study design that waste is reduced,” Hoban explains. “Typically, there is a lot of focus on where we want the patients recruited for the trial coming from Big Pharma, so we can estimate how many patients we can recruit in a timescale. This means that we know the amount of stock required before we replenish, so that natural process can start quite early.
“We don’t leave these things to assumption, it’s constant reviewing of all the elements of the trial that impact when patients are likely to be available so that the correct amount of inventory is planned to be in the right place at the right time so they can get treated.”
Aposave can help clients procure multiple batches of medicines in agreed quantities, along with the necessary documentation. As part of the Abacus Medicine Group the company has extensive supply networks, and its advisory services help clients to design a solution that means only minimal product gets destroyed.
This includes a methodology that helps customers to recycle surplus products through parent company Abacus Medicine. Aposave can support companies with short-dated stock and buy it back from them and then repackage the product and sell it to their hospital customers.
Aposave’s unique industry position means they can work with clients from start to finish, helping to ensure that trials have the right amount of product at the right time.
For more information about how Aposave could save your company money and provide innovative clinical trial solutions, download the whitepaper below.