Outsourcing
Brave new world? For much of the Western world, the Covid crisis is finally spluttering to a halt. But the changes wrought by the pandemic are far from over. Though travel bans have mostly been consigned to history, to give one example, 91% of trial organisers expect to exploit the power of remote monitoring by the end of 2022. And as Getz notes, this is hardly surprising if you appreciate how much more efficient Covid-era trials could be. “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.” Certainly, Getz’s point is amply reflected by the statistics. Beyond the remarkable speed of remote trials, after all, one 2019 study also found that dispensing with on-site monitoring can cut overall trial costs by 30%. Even better, no longer forcing patients to trek to trial sites can improve retention rates. Yet if the advantages of Covid-era trials are clearly understood – Pfizer and Merck are just two of the industry giants to investigate their potential even as the immediate crisis has eased – it would be wrong to assume that the industry can simply continue as it did in 2020. “It is too early to predict which approaches will become permanent,” warns Getz, adding that though the clinical community is obviously proud of its achievements, recreating the cocktail of conditions that sparked his ‘Grand Pilot Study’ is far from simple.
If nothing else, this hesitancy can be understood in terms of regulation. Put it like this: if the FDA was understandably happy to loosen the rules in the midst of a terrifying global pandemic, might it not return to a more cautious stance now that many Americans are vaccinated? The same could be said of data sharing. While the pandemic encouraged researchers to share what they knew for the good of humanity, are less serious threats likely to elicit the same goodwill? This is not an idle question: given the clinical trials sector is already worth $47bn, there’s plenty of money to be made by staying cynical. If getting patients to grips with remote medical equipment is one challenge, Getz highlights that training data scientists, able to parse mountains of sophisticated new information, is quite another. “Attracting, developing and retaining talent,” he says, “is considered one of the most important areas at this time – and one of the most challenging.”
Keeping at it
All the same, Getz seems optimistic about the future of clinical trials. When it comes to staffing,
Clinical Trials Insight /
www.worldpharmaceuticals.net
for instance, he notes that their increasingly remote nature means that “talent can be accessed and engaged anywhere”. At the same time, there is evidence that pharma companies are working hard to hire. GSK, for example, now makes a special effort to promote women in tech. Roche, for its part, showcases real world data scientists on its website. That is reflected by a warmer regulatory climate. The relaxed approach taken during the pandemic may have been gone forever, but bodies like the FDA are arguably becoming more accommodating – while ethical review committees are becoming more laid back too. Among other things, that could mean improving communication between researchers and reviewers, ensuring that new academic papers are published faster.
Global pharmaceutical company, GSK, is making a special effort to promote female talent in tech.
“Attracting, developing and retaining talent, is considered one of the most important areas at this time – and one of the most challenging.”
No wonder, then, that Getz expects to see clinical trials ultimately retain many of the accoutrements they gained during Covid-19 – in the more distant future anyway. “In the short-term,” he says, “many will add cost and time as pharma companies and their collaborators must learn how to juggle and adopt multiple approaches simultaneously. In the longer-term, we anticipate cost-efficiency and time savings. We also expect to see improvements in access to clinical trials among underserved patient communities.” A lot to be hopeful about, then, even as our bewildering experience with Covid gradually fades into memory. ●
30%
Dispensing with on- site monitoring can cut overall trial costs by this amount.
Clinical Leader 31
Blue Planet Studio/
Shutterstock.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53
