Clinical supplies & logistics
pandemic haven’t been entirely happy. Especially around the knotted question of supply chain management, but also around keeping patient data organised, the clinical trial sector is still battling to fully decentralise. But with the rapid spread of new technology, as well as the parallel sharpening of industry partnerships, genuine success looks closer than ever.
A growing trend
Laulajainen is quite right to note the pre-pandemic march towards DCTs. Even before anyone had heard of Covid-19, after all, 28% of sponsors and contract research organisations were already integrating digitalisation into their trials. Nor is this trend particularly hard to understand – if nothing else from a financial perspective. As recent work by the Tufts Center for the Study of Drug Development uncovered, decentralised phase 3 trials can be completed significantly faster than their on-site counterparts, a situation that could ultimately lead to net benefits 14 times greater than the initial investment. That’s shadowed by other cost-saving opportunities. Decentralised trials require fewer expensive review boards, for example, even as protocol changes can be prodded through without fuss.
But for Kevin Ketels, assistant professor of teaching in global supply chain management at Wayne State University in Michigan, to focus entirely on the bottom line is to miss the point. “Because decentralised trials are more convenient,” explains Ketels, who spent nine years as CEO of clinical research site management organisation KMED Inventory before taking on his academic role. “You could potentially increase the number of research subjects.” This intuitively makes sense. Allowing patients to test new drugs from the comfort of their own homes, trial organisers are more likely to secure a range of subjects from different backgrounds, potentially bolstering results – nothing to sniff at when only 5% of eligible patients currently sign up for clinical research.
Examine the sector for long, however, and it becomes obvious that for every benefit, DCTs can also pose a number of difficulties. “There are several challenges with the DCTs inherent to the supply chain,” emphasises Antonio Tramontano, a life science supply chain specialist at Genpact – a global IT firm that supports clinical trials. For one thing, Tramontano says that getting drugs to hundreds or thousands of individual locations can be hard, especially when some drugs need to be stored in temperature-controlled conditions until they reach their destinations. At the same time, Tramontano notes that the virtual supply chain is severely impacted by decentralisation. True enough: if hub-based trials meant patient data could be collated from a single
Clinical Trials Insight /
www.worldpharmaceuticals.net
building, securing quality information from countless smart watches or online video sessions can be a muddle. More to the point, the consequences of getting any of this wrong can be fatal to a trial’s progress. In 2021, a number of Stanford researchers admitted terminating a trial into virtual cardiac rehabilitation after suffering technological snafus, including the inability to get the relevant data-collection app to work on subjects’ smartphones. Naturally, failures like this risk undercutting whatever financial benefits digital trials offer in theory, even as Laulajainen warns that patient outcomes risk being hampered too.
Tracking changes
In a sense, failures like the Stanford trial are unsurprising. Only fully entering the mainstream in the wake of Covid, it was always going to take time for trial conveners to get to grips with DCTs in all their complexity. Yet listen to industry insiders and it’s equally apparent that the years since lockdown have seen a number of improvements; for Laulajainen, one of the biggest is technology. “Technology,” he says, “can play a significant role in enhancing the supply chain process. Logistics trackers and temperature trackers have been widely used for some time. However, emerging technologies such as artificial intelligence or tokenisation could revolutionise supply chain
“Emerging technologies such as artificial intelligence or tokenisation could revolutionise supply chain management by improving transparency, traceability and real-time monitoring of shipments.”
Tero Laulajainen
management by improving transparency, traceability and real-time monitoring of shipments.” Certainly, such enthusiasm is shadowed by the statistics. Helping researchers understand clinical results from a range of physical sources, the global market for AI in clinical trials is expected to reach $4.8bn by 2027. Technology can have an equally significant role in ensuring drugs reach far-flung trial centres to order. In Genpact’s case, Tramontano and his colleagues ensure shipments are logged digitally. In the case of deviations during and after the delivery, he says that damaged goods can be returned and replaced promptly. In a similar vein, the Genpact executive says that external partnerships with logistics firms are vital too, explaining how lacing the same data and processes from one end of the supply
19
ArtPanupat/
Shutterstock.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45
