Regulatory
along by the Covid-19 emergency, trial conveners are now able to collect reams of data across the spectrum of medical life. The future, in short, looks bright – in no small part thanks to work of one of the world’s premier regulatory bodies. Early this year, the US Food and Drug Administration (FDA) published new guidelines on how to use new technology to capture clinical data, along the way offering sponsors an avalanche of suggestions on which devices to use and how to apply them. Yet, if digitalisation is increasing in popularity – an estimated 1,300 decentralised trials started this year alone – challenges remain. To a significant extent, that’s down to the industry itself. If, after all, conveners now gather millions of data points each trial, they also need to actually make sense of it all, separating valuable insights from mere noise. That’s shadowed by security challenges. In a world where over two-thirds of companies have become victims of cyber attacks, this new generation of trials, one ensconced in ones and zeros, must battle hard to avoid any breaches.
Machine, learning
Jennifer Goldsack can pinpoint the moment she realised digitalisation was destined to transform clinical trials. It was 2015, and she remembers reading a New England Journal of Medicine paper about heart patients and how the researchers used accelerometers to measure subject cardiology. It may not have been a drugs trial, but Goldsack nonetheless stresses that the study offered “really compelling” results. “You could use accelerometery data to distinguish between healthy patients and patients with heart failure,” continues Goldsack, a clinical trial veteran and now CEO at the Digital Medicine Society (DiMe). “It really made the industry stop and pause.” To put it another way, if the travel bans and distancing mandates of the pandemic accelerated the adoption of digital devices, Goldsack argues that the wave was cresting years earlier. And if you simply consider how the public uses technology, it’s undoubtedly a plausible argument. Between smartwatches (due to generate $53.6bn by 2025) and health apps (boasting 87.4 million users in the US alone), clever machines to measure our health are increasingly normal. Nor is Goldsack alone here. “As long as the outcome being measured is meaningful to patients and clinically relevant, and the burden of the technology is not great,” explains Lindsay Kehoe, a senior project manager, Clinical Trials Transformation Initiative (CTTI), “then patients are often willing to use technologies to improve their clinical trial experience.” It’s a point bolstered by the facts too: according to one 2019
Clinical Trials Insight /
www.worldpharmaceuticals.net
survey, 81% of people reported they were happy to participate in mobile tests.
In large part, these wide cultural shifts help explain regulatory advances. Boasting a grand title – ‘Digital Health Technologies for Remote Data Acquisition in Clinical Investigations’ – the FDA’s January report offers over two dozen pages of notes on facing this new world of clinical trials. That’s reflected, Goldsack suggests, by the sector as a whole. The whole point of the FDA, after all, isn’t really to take the lead in promoting changes to how research is done. Rather, the Maryland organisation exists, Goldsack says, to “watch industry closely” and “follow the science with appropriate regulatory policy”.
As long as the outcome being measured is meaningful to patients and clinically relevant, and the burden of the technology is not great then patients are often willing to use technologies to improve their clinical trial experience.”
Lindsay Kehoe Down to a DHT
Beyond what it says about the dynamic state of clinical trials, the FDA guidance’s main focus can be summarised in three words: digital health technologies. Known to the industry as DHTs, they’re essentially the devices conveners use to collect subject data. Smartwatches and other wearables are the most obvious example here but listen to Kehoe and it’s clear that there are plenty of alternatives too. Among other things, that includes smart glasses (to investigate glaucoma), glucose monitors (to study diabetes) and even sensors embedded into clothing (for monitoring heart or breathing rates). Not that all of these machines are necessarily medical devices. On the contrary, Goldsack says that, reflecting the chimeral spread of digital trials across the sector, the FDA has taken an open-minded approach to what’s permitted, emphasising that Apple watches and other commercial devices are acceptable as long as they gather data reliably.
More to the point, Kehoe explains that this strategy goes a long way towards reassuring muddled insiders. Until the FDA released its report, she argues that “regulatory clarity was still needed to help push the adoption”. That’s true, she continues, across a range of important explanations. One is if regulators would accept the inclusion of DHT-derived findings in anything beyond exploratory research. Another is how to validate a result if there isn’t anything to compare it against. This flurry of clarifications is
$7.8bn
The value of the global virtual clinical trials market in 2021.
Grand View Research 9
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