Clinical supplies & logistics Lessons in
hree years after the first vaccines were approved, Covid-19 is increasingly seen as the defining clinical moment of our century. Forcing conveners to dramatically shift how trials occurred – expediting testing with the help of regulators – it feels reasonable to agree with one senior clinician at Rutgers University that the pandemic “challenged the traditional approach” to how clinical research was done. The same is true, we’re often told, of where trials took place. In a world of lockdowns and social distancing, conducting central hubs risked doing more harm than good, with researchers instead opting for a decentralised trial model to provide investigational medicinal products (IMPs) directly to participants.
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logistics
Even before the pandemic, researchers were moving away from in-person clinical trials and towards digital alternatives, and the trend was only escalated by the required lockdowns and social distancing. And why not? Offering a range of advantages over traditional
alternatives, decentralised clinical trials are revolutionising how the industry works. But with test subjects increasingly dispersed in their own homes, researchers need to ensure their supply chains are up to scratch – which may mean investing in new technologies in areas like data collection. Andrea Valentino investigates, talking to a range of experts from across the industry.
It would be foolish to suggest that the pandemic and its consequences had no impact on the rise of decentralised clinical trials (DCTs). Just consider the statistics: according to work by Veeva Systems, the implementation of decentralised clinical studies skyrocketed by 59% compared to the pre-Covid age. Yet talk to the experts and it soon becomes apparent that decentralisation ultimately represents far more than merely a response to the exigencies of the pandemic. “While there was already a move towards DCTs before 2020,” says Tero Laulajainen, head of global clinical science and operations at Belgian pharma giant UCB, “the Covid-19 pandemic accelerated the adoption of remote approaches.” Its a fair point: higher patient diversity and lower costs are just two of the benefits of embracing a decentralised style. Yet if DCTs offer organisers and patients plenty of advantages, the years since the
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Clinical Trials Insight /
www.worldpharmaceuticals.net
Abscent Vector/
Shutterstock.com
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