Clinical supply & logistics


Several clinical trial companies are interested in sliding new technologies into their trial chains.


requirements around clinical trials – at least until first doses were safely in European bloodstreams.


Never break the chain This talk of flexibility is well and good for understanding how clinical trials have changed in general, but what does it actually mean for their supply chains? It’s a question that can be answered, Vela suggests, beginning with patients themselves. For the first time ever, 2020 saw Roche take some of its trials remote – with drugs delivered to patients at home, rather than waiting for them at a clinic. Unless someone had been living in the woods for the past 18 months, they would understand how this became a necessity in a world driven by lockdowns. More to the point, says Vela, having patients test medication from the comfort of their own homes helps put them at “the centre” of the trial experience. Given this model can boost patient recruitment by up to 60%, and maintain patient retention at over 95%, there are clearly benefits here for trial organisers too. None of this would have been possible without new technology. That’s especially true with blockchain. Being able to track and trace every order on a digital ledger not only gives patients peace of mind that their medication is being kept safe, it also allows trial scientists to ensure that doses are getting to their destinations without problems. The same is true of instantaneous temperature and status monitoring. With trial organisers now able to use the internet of things to check even the speed of a drug delivery truck, the sorts of colossal trials we’ve seen for Covid-19 vaccines will obviously become easier going forward, and at a stroke, secure precious data for researchers as trials progress. Beyond Roche, other companies are clearly interested in sliding new technology into their trial chains too. Even before the pandemic, Pfizer and Biogen had developed a working group to prove that blockchain could keep supply chains secure. And since ‘social distancing’ and ‘self-isolation’ have entered our common vocabulary, Bayer, Transgene and several


Clinical Trials Insight / www.worldpharmaceuticals.net


UK NHS hospitals have all decided to go down a similar path in terms of these regulations. Of course, relying on technology inevitably raises the possibility of hacks or other data breaches. At Roche, Vela is clearly conscious of these dangers. “All the systems that work within the Roche network are properly tested and validated from our IT department,” he says. “Talking in more detail about patients’ [personal data] in home delivery, for example, transport and logistical companies, which have a wide expertise in this field, give us the operational support, so no data from the patients is transferred directly to Roche. Once implemented, we just need to ensure proper information and monitoring the service level are performing well.” This is shadowed by similar developments across the industry.


Tech you out


Now that the pandemic is finally subsiding, how might experiences of Covid-19 impact the development of the clinical trial supply chains more broadly? Vela is unequivocal. “These innovative projects,” he says, “means changing the way we worked in the past”. In particular, he cites Roche’s home delivery initiative that, he suggests, provided a “proper solution” in record time. According to one 2020 survey, around half of clinical trial investigators expect clinical trial decentralisation approaches – including home delivery and online recruitment – to increase. Beyond that, it seems clear that digitalisation will continue to trickle down the supply chain in other ways. Once again, the numbers are instructive. The market for electronic trial master files is expected to grow by 16.5% CAGR from 2019 to 2027, while 70% of trials will use wearable sensors to track patient progress by 2025. “Evaluating what is better for the patient, and the success of a clinical trial,” summarises Vela, “makes you implement new ideas following an agile methodology that makes the innovation possible.” If only Parry, Hill and their anonymous Chinese forebears could come back and see it. ●


30,000 The number of


patients AstraZeneca enrolled in its Covid-19 clinical trials, across 80 sites in the US alone.


National Institutes of Health 19


noppawan09/Shutterstock.com


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