Outsourcing
Video conferencing tools have made it easier to collaborate on research projects throughout the pandemic.
patients from physically visiting test sites? And with millions of new cases announced each day, how could researchers rely on official data alone? Beyond timelines, in other words, the profession has been forced to grapple with a plethora of new trial techniques – with vast consequences for doctors and patients alike.
“This Grand Pilot has demonstrated that drug development conditions that have long plagued the pharmaceutical industry – high levels of inefficiency, long durations, suboptimal relationships with regulators, low success rates – can be eradicated when critical success factors are simultaneously well-coordinated and executed.”
$20bn CEPI 30
Together with schemes like Operation Warp Speed, CEPI has invested this amount into Covid research.
Now that the pandemic seems to be receding, an even more interesting question will soon need to be broached: can these changes last? Though they started as knee-jerk reactions to a terrifying virus, after all, it’s quickly becoming apparent that greater speed and flexibility can be a boon to trials big and small. Not that totally abandoning traditions built up over decades is easy – or even possible. From regulatory challenges to worries around training staff, clinical trial insiders have plenty to do before the shifts wrought by Covid-19 can be made permanent. Succeed, however, and their field could be transformed forever.
Efficiency changes
If you want to understand how drastically clinical trials were changed by Covid-19, you could do worse than ask Professor Kenneth Getz. Executive director
at the Tufts Center for the Study of Drug Development, Getz has worked in the clinical trials space for more than two decades. And as he emphasises, there is now a vast gulf between the pre- and post-Covid worlds. “The pandemic,” he explains, “has been the ultimate or ‘Grand Pilot Study’ demonstrating how multiple factors, well- mobilised, integrated and coordinated, can deliver remarkable innovation, speed and quality.” Examine the dream-like story of the pandemic, and where exactly this occurred becomes obvious. Lockdowns and travel bans, for instance, prodded developments in home visits and wearable devices, with isolated patients monitored by researchers across the country. Technology also promoted a new appreciation of data sharing. With tools like Zoom and MS Teams making collaboration simpler than ever, Covid’s genome sequence was shared far and wide, while patient data was rapidly exploited too. In the US, for example, the National Covid Cohort Collaborative (N3C) began to systematically collect records on Covid patients. All this was echoed by new enthusiasm for experts. As politicians scrambled to limit the impact of Covid, bodies like the Coalition for Epidemic Preparedness Innovations (CEPI), founded in 2016, suddenly found new backers in governments the world over. As these references to MS Teams and CEPI imply, it’d be wrong to suggest that this new reality was born overnight. On the contrary, Getz says “familiarity with nearly all of these factors” had “already been established” – with the pandemic merely acting as a starting gun on implementation. Whatever the cause, it is clear that Covid drastically changed the state of play. At N3C, for instance, researchers have already collated 6.3 million patient records from over 50 institutions. Together with schemes like Operation Warp Speed, CEPI has pumped $20bn into Covid research. With that kind of cash floating about, it is also unsurprising that research times have tumbled – by up to 70% according to one study.
That is shadowed by dramatic shifts in how clinical trials were actually run day-to-day. In 2020, 76% of clinical trial sponsors said they conducted most or all of their research monitoring remotely, up from just 18% in 2019. That obviously impacted patients themselves. Rather than physically travelling into clinics, many self-administered drugs from the comfort of their sofas. Naturally, this also meant patients and doctors had to become comfortable with new technology, for instance when it came to heart- rate monitors or smartphone applications. As Getz adds, that further involved close contact between trial organisers and external partners, notably contract service providers and investigative sites.
Clinical Trials Insight /
www.worldpharmaceuticals.net
AnnaStills/
Shutterstock.com
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