Clinical supplies & logistics
the simple fact that the end of an experiment is less exciting than the optimistic start, reverse logistics has traditionally been shunned by the trials industry. At the same time, ignoring reverse logistics can have serious real-world consequences. With strict rules in place about how unused medications need to be handled, snubbing reverse logistics can get the organisers and sponsors of trials into legal trouble. From a financial perspective, meanwhile, being disorganised at the close of a trial often means unnecessary costs and delays. At worst, this can even impact the data painstakingly gathered over months and years. Even so, the situation is far from hopeless. Buoyed by new technology, which makes tracking components easier, trial insiders are finally embracing reverse logistics in all its variety.
End of the line
Few people are better placed to appreciate the sophistication of modern clinical trials than Kimberly Finn. A veteran in the field for nearly 30 years, she’s worked everywhere from cardiovascular metabolism to oncology. Since 2018, meanwhile, Finn has been vice president of global patient centric services at Marken, a Chicago clinical supply chain firm and subsidiary of UPS. What Finn has to say, in other words, is worth listening to – and she is clearly keen to stress the importance of reverse logistics, at least in theory. “It is quite important,” she says. “Most institutions will have SOPs regarding the proper destruction of medications – because we can’t just throw them in the receptacles most of the time.”
As this last comment implies, the need for reverse logistics can be understood in two ways: the vast surplus clinical trials frequently end up with, and the regulatory obligations that accompany them. To take the surplus first. From storage conditions to expiry dating, to say nothing of patients that leave a trial early, planning the minutiae of a trial in advance is often impossible. Naturally, this means that clinicians are often left with leftover drugs – either reusable or which have to be disposed of safely. Combined with the rise of digital accoutrements – think wearable devices for monitoring vital signs, especially important in our new era of lockdowns – and the materials trials have to contend with soon balloon. It similarly follows that all this comes with a serious dose of regulation. Beyond individual SOPs, regulators like the European Medicines Agency have robust guidelines for how to deal with unused drugs. Nor is this very surprising: dumping pills in the bin is fine until they are sold on the black market or discovered by a curious teenager. Yet speak to the experts and it soon becomes clear that the theory of reverse logistics has traditionally clashed with the reality. For Edward Groleau, clinical supply chain director for North America at PCI
Clinical Trials Insight /
www.worldpharmaceuticals.net
Pharma Services, reverse logistics is “very much” underappreciated across the sector. Perhaps most fundamental here are the vagaries of human nature. “The exciting part of the trial is over and everyone is anxious to see the results plus planning the next phase of the development programme,” is how Groleau puts it. “Dotting the final I’s and crossing all the T’s is not what people want to do.” That’s shadowed by the frustrating complexity of the whole process. Tracking trial materials is generally a shared responsibility, involving different stakeholders across different locations. As Groleau bluntly says: “Wading through mounds of paperwork to count trash is not an exciting task anyone looks forward to doing.”
“The exciting part of the trial is over and everyone is anxious to see the results plus planning the next phase of the development programme. Dotting the final I’s and crossing all the T’s is not what people want to do.”
Edward Groleau
Whatever the reasons for lapses, it is indisputable that ignoring reverse logistics has a number of drawbacks. One issue involves data. As Finn explains, a trial will inevitably be less accurate if crucial patient statistics are left on devices forgotten in a corner. Information matters in other ways. “The people completing the reverse logistics are forced to chase down the information needed,” says Groleau. “This can be happening years after the trial started, so documentation can be lost, and with personnel changes it may be impossible to recover the information.” Apart from again damaging the informational integrity of a trial, this risks leaving researchers with an unfavourable audit review. Of course, all this messing about can be expensive – hardly ideal when drugs already typically cost an eye-watering $985m to develop.
Working backwards
Given the convoluted nature of reverse logistics, it is probably unsurprising that any solution requires what Finn calls a “strategic” approach. Her work at Marken is a case in point. When her team has an opportunity to supply medications to trial sites, for instance, she emphasises that reverse logistics is examined right at the start. Among other things, that covers regulation and trade compliance: Marken boasts a regulatory database that trial planners can use to understand exactly what needs to happen when medications go to the big warehouse in the sky. Nor is the Chicago firm alone. Like Marken, Groleau’s PCI Pharma Services is moving in a similar direction, using a client portal to
$19bn
The market for clinical trial logistics is currently hovering around this mark – it is expected to reach $28bn by 2026.
GlobeNewswire $985m The cost of
developing drugs. LSE
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