Clinical supply
Pharmaceutical companies are taking the move to decentralised trials seriously, ensuring their shipments arrive promptly and securely.
trials. Yet, it’d be wrong to suggest that clinicians can click their fingers and expect direct-to-patient trials to simply happen. On the contrary, moving trials outside medical settings requires sophistication and nuance, especially when it comes to supply chains. While older models only need drugs to reach specific clinics, decentralised systems require them to land on the doormats of perhaps thousands of individual subjects – on time and without damage. To be fair, there are signs that pharmaceutical companies are taking these challenges seriously. At World Courier, a global leader in medical supply chains, staff liaise closely with delivery companies to ensure shipments arrive promptly, using sophisticated GPS tracking to keep an eye on trucks. At Lash Group, another major player, clinicians frequently go to the homes of participants, preparing treatments and teaching them to administer injections properly. As so often in the world of supply chains, technology is proving remarkably useful here, and not just when it comes to established wizardry like GPS. Companies like GSK, for example, are using blockchain to ensure drugs get from the factory to the patient transparently. Roche, for its part, has experimented with big data to understand the optimum temperatures of different drugs, ensuring they reach their destination before they become unusable.
Beyond this physical chain, Agrawal highlights the importance of keeping virtual supply chains secure. Arming subjects with data watches is a good start, but ultimately means little if the information they send clinicians is inaccurate or incomplete. Burke makes a similar point. Accurate data is the ‘foundation’ of any successful trial, she says, and unreliable data risks corrupting the results. Yet here too, there are reasons for optimism. As direct-to-patient trials become more popular – one recent survey found 73% of respondents said they increased their use of decentralised trials during the pandemic – Agrawal expects data analysis
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to improve. “Broader adoption,” he suggests, “will increase efficiency for investigators and sponsors due to better digitalisation and data management.” There are signs this is happening already: heart monitors, for instance, can now offer accurate readings 24/7.
Remote control
Where does that leave direct-to-patient supply chains – and decentralised trials more generally? Agrawal, for his part, is sanguine. He argues decentralised – or at least hybrid – trials will become “more standard” as patient expectations shift towards staying at home. Burke agrees. “Advances in technologies have opened the door to broader applications of direct-to-patient trial designs,” she suggests, adding that telecommunications in particular have dramatically improved since the first lockdown. This is echoed by developments in how supply chains are managed. Among other things, pharmaceutical companies are promoting collaboration in their workflows, with companies battling hard to integrate people, technology and data into a single package. Even so, both experts warn that difficulties remain.
With all this data floating about – all from different sources – data protection is more challenging than ever. That inevitably raises regulatory questions too, not least given how quickly remote technology is advancing. Then there’s the issue of orchestrating a complex direct-to-patient supply chain across borders. “Trials conducted in more than one country are subject to additional cross-border data standards, as well as localisation and retention rules,” says Agrawal. “Therefore, it is essential for creators of a global trial to use a tailored approach, design an optimal country footprint at the outset, and account for complexities in trial-design planning.” These are all fair concerns. Yet, given how far clinical trials have come from the days of Austin Bradford Hill, there’s surely cause for optimism. ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
Chaay_Tee/
Shutterstock.com
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