Supply chain logistics can make or break a clinical trial. In many cases, failure to provide and manage trial supplies on time has resulted in costly delays. So how does a CRO partner work with a sponsor to ensure supplies are properly managed?
Over the next few weeks, stay tuned to PSI On Point to learn about “seven deadly sins” of trial supply management, brought to you by PSI Trial Supply Manager, Alan Morton.
Last week, we looked at the deadly sin of lust and walked through the dangers of chasing after the wrong vendor for trial partnerships. This week, we’re diving back in and looking at our second warning sign…. gluttony.
Gluttony (50% overage? – That sounds ok, right?)
Over-production. All studies need a certain amount of overage, but kits left over at the end of a study are often seen as wasted money. There’s more to the story than that, however. When supplies are both available and priced low, it often costs less to produce more supplies and send one large quantity shipment to the sites than it would cost to ship smaller quantities in multiple batches.
However, this logic is reversed when the drugs are either expensive, hard to obtain, or both.
Let’s look at one example together. An 800 patient study getting ready to launch requires 3-4 vials per patient to be dispensed every 3 weeks for over a year. Each vial can cost upwards of £677 for the drug alone. And if we do the math, it adds up quickly: the drug cost is over £10m! Not including other aspects of the trial, or any other necessary supplies, we can easily see that even little overages in shipping and production can quickly impact the cost of the trial.
Making the Right Calculation
The correct amount of overage is never an easy calculation. In order to define our overage parameters, we need to understand the risks involved in the study and ensure that we have overage to cover those risks. Damaged shipments, temperature excursions at the site, broken vials, missing kits, environmental damage to a depot, and so many other factors are all considered as risks throughout the trial supply process. And while not every risk will actually hit on every single study, suppliers and CROs need to ensure that they both understand the exact factors and that they have a continuity of supplies to treat current and future patients.
With the right overage calculation, a study would never see delays from drug shortages, nor would they see outrages costs from excessive supplies. Having a higher buffer at the start of a study provides flexibility. Once patients are recruited and we understand locations, visit schedules and dosing information, we can tailor shipments to meet the site/patient requirements and optimize on-site supply stock accordingly.
The Right Tools, The Appropriate Resources
The use of IXRS systems helps consolidate shipments for multiple patients and treatment visits, and the lookout windows can be altered to provide the ideal frequency of re-supply shipments. And other tools, resources, and algorithms can come into play to fine-tune the supply process to eliminate excess overages.
Every excess cost is a bill passed on to another business owner in the clinical trial partnership. When overages aren’t calculated properly, trials could either be delayed, over budget, or both. Mitigate that risk by fully understanding risks in trial supplies, and investing in the appropriate tools and resources to make the right overage calculations and judgments. Don’t fall into the sin of gluttony in drug supplies: 50% overage without a proper calculation? It’s time to evaluate.
Next in The Series:
Stay tuned for the next deadly sin to avoid, and find out about how a CRO can partner with vendors on behalf of sponsors to ensure trial supplies aren’t just an aspect of the project, but a successful arm of the product.
Alan Morton, Trial Supply Manager
Alan has been working in the logistics and supply chain arena for almost 30 years and has spent the last 7 working for market-leading drug supply and packaging vendors supporting studies all over the world.