Clinical supplies & logistics
Getting drugs to hundreds or thousands of individual locations can be hard, especially when some drugs need to be stored in temperature- controlled conditions.
chain to the other can help avoid mistakes. Ketels agrees, noting that the technology trackers used to follow medical shipments have become “much more sophisticated” over recent years.
Regulators, for their part, are doing their best to make things as straightforward for investigators as possible. “While organisations build up experience of running decentralised trials, we encourage them to approach the MHRA for regulatory advice, especially where supply chains or the dispensing process are likely to be complicated,” a spokesperson from the British regulator says, an openness that is echoed on the other side of the Atlantic aswell. Piggybacking on the industry- wide gusto for technology, meanwhile, the MHRA is also using data to make other parts of the DCT process simpler. Liaising with academics from the University of Birmingham, for instance, the MHRA’s Clinical Practice Research Datalink service uses NHS data to track the health outcomes of patients with irregular heartbeats.
Decentralised ascent $4.8bn
The forecasted global market value for eClinical trial solutions (including AI) in 2027
ASDReports 20
In short, it seems clear that if post-Covid DCTs got off to a wobbly start, the future looks increasingly positive. Not that anyone would say the sector is there quite yet. For Tramontano, one continuing issue involves the lack of international cooperation, stressing that a “common roadmap” for large multinational DCTs has yet to emerge. This is doubtless causing problems in practice; in March
the South Korean government totally blocked decentralised trials in their country. In a broader sense, meanwhile, Tramontano suggests that, present cooperation notwithstanding, the industry must still do more. “A broad expansion of DCTs,” he says, “will require a ‘tipping point’ of collaboration and coordination among all the stakeholders, including patients, in order to model the multi-party commitments that a full-scale implementation will take.” To be fair, the industry is battling to overcome these hurdles too. As always in these situations, specialised vendors seem eager to fill the breach, offering specialised tracking technologies to ensure decentralised medications reach homes and clinics alike. “As technology continues to evolve,” says Laulajainen, “we must leverage emerging tools and platforms to enhance our supply chain capabilities. This includes utilising advanced data analytics and leveraging AI and machine learning.” There are certainly exciting developments on the horizon here. At Merck, for example, managers are starting to use machine learning to understand where in the DCT supply chain drug shortages might occur. UCB, for its part, is going down a similar path, unveiling non-intrusive sensors that can measure a patient’s vital signs without them needing to ever disrupt their daily schedule. There are doubtless improvements to be made, but decentralised trials continue to transform how drugs are tested and approved. ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
Lars Poyansky/
Shutterstock.com
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