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 wrath. Don’t forget – we’re all on the same team in the long run. This week, we’re diving back in and looking at our sixth warning sign… pride….
Pride (I know what I’m doing – how dare you question me)
It’s easy for us to fall into the same habits and trust our own expertise. But often times, our pride in knowledge and experience gets in the way of innovation, improvement, or, for better terms, lack of thinking… Let’s look at an example.
In the post-study review of an antibiotics trial, data showed that 82% of the kits produced during the study were never used. Some expired, some were damaged, some had temp excursions, and some were never sent from the central depot to the sites. The majority of the unused kits sat on the shelves at the sites at the end of the study because the number of reserves held at each site to support recruitment was too high. The clinical team insisted on having enough of the blinded drug on site to treat 3 patients concurrently. A review towards the end of recruitment of this study, however, showed that the average site only managed to recruit 1 patient every 3-4 months. Of the 900+ patients recruited, less than 30 were in treatment at the same site at the same time as another patient.
Letting Pride Get In The Way? Consider Your Risks.
Setting a study up without considering potential disruptions or complications is folly. What was once appropriate for the start of a study may not actually be appropriate as it progresses, and we have to keep that note in the forefront. Re-visiting and updating the plan with actual information is vital to ensure that the right decisions are made at the appropriate time. This could mean varying the timing or quantity of re-supply campaigns, changing the courier type, or even deciding that an in-country depot would be more appropriate than direct to site shipments. In the previous example specifically, it means altering the buffer stock appropriately throughout all phases of the project.
Unfortunately, the stock status and levels of excess were discovered too late to reduce the site supplies to a level where it could be used by the patients remaining to be recruited. The stocking decision was based on previous experiences with other studies, rather than weighing the considerations of the current study.
And to save a lengthy explanation, it was due to the fact that pride got in the way. We all know what we’re doing, all the time, right? We’re experts. We have years of experience and have worked on dozens of studies in the same indication, right? That doesn’t mean we can fall into the habits of setting up studies the same way every single time.
Innovate, Improve, Learn
As a CRO, it’s our job to tailor every study around every aspect of the project, rather than using some sort of template to run a program. We have to ensure that we’re digging in, learning new aspects, innovating, and improving at every stage of every study. And when we’re managing trial supplies specifically, this has to be a key focus.
What’s the answer, here? Don’t let the pride of experience outweigh the benefit of consulting, learning, and improving. It’s never too late to innovate.
Next In The Series:
We’ve looked at 6 of our 7 deadly sins, and that means we’re rounding the series out next week with one that we all have to be aware of in trial supply management. Stay tuned for tips and tricks to learn about how to manage your…that’s right…envy…
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.