Clinical supply & logistics
to stand for excursions, even if they are small.” Another difficulty particular to trial supply chains is patient anonymity. As Vela puts it, it can be a “big challenge” to keep the data of thousands of trial patients organised and secure. That’s doubly true given data security is now such a mantra across industry and serious fines for data breaches aren’t unheard of.
Pfizer’s vaccine trial included 43,998 people, while AstraZeneca enrolled 30,000 patients across 80 sites.
As Javier Garcia Vela, a transport and logistic services team lead at Roche, explains, practically all his company’s work requires close collaboration with suppliers and hospitals, doctors and patients. Yet in some important ways, continues Vela, the struggles around supply chains for clinical trials are even tougher. One problem is managing the cold chain for trial drugs without much data.
“The pandemic made us realise that we need to be more flexible in some situations, and that not following the usual path can result in new and successful approaches.”
“I think one of the biggest challenges in the clinical trial supply chain,” explains Vela, “is the temperature monitoring and maintaining the temperature ranges for a delivery of products, which usually don’t have stability data available
These are undoubtedly questions that have vexed trial experts for years. But you get the sense that they’ve also been exacerbated by the scale of the pandemic and people’s response to it. Consider the statistics. Since April 2020, there have been over 5,000 registered Covid-19 studies worldwide. Patient numbers are similarly impressive. A far cry even from the 3,000 typically mandated by the FDA, Pfizer’s vaccine trial included 43,998 people. Merck’s effort topped 65,000. In the US alone, AstraZeneca enrolled around 30,000 patients across 80 sites. It goes without saying that the logistics of such an operation are bewilderingly complex – and that’s before you even factor in that many trial participants were legally banned from leaving their homes. How, then, have major pharmaceutical companies like Roche reacted? When it comes to a big picture response, Vela suggests that agility has been key. “The pandemic made us realise that we need to be more flexible in some situations, and that not following the usual path can result in new and successful approaches,” he explains. “Sometimes, taking some risks is necessary when you need to implement something in an agile way: not having the perfect approach first, but implementing something that works and then you will have time to improve it.” Vela and his Swiss employer are certainly not alone here. In the UK, for instance, scientists working on the AstraZeneca vaccine unusually conducted several stages of their trial at once. Across the Channel, regulators were happy to waive some of the more onerous reporting
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Clinical Trials Insight /
www.worldpharmaceuticals.net
Leonard Zhukovsky; Foxeel/
Shutterstock.com
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