Regulatory
The FDA has taken an open-minded approach to what’s permitted, emphasising that commercial devices are acceptable as long as they gather data reliably.
probably just as well and not just for conveners worried about falling out with regulators. As Kehoe says, the rise of DHTs increasingly offers organisers a host of new ways to flex their technical muscles. To give one example, Kehoe brings up exploring why some people end up scratching themselves while sleeping.
Not that digital trials can hope to rely on the FDA alone. For one thing, planners need to think carefully about how to actually employ their devices. Returning to the example of sleep, this intuitively makes sense. While a motion sensor might tell us when someone unconsciously scratches themselves, it can tell doctors little about the underlying causes, for instance whether it’s down to a dermatological condition or something psychological. Goldsack, for her part, comes at these problems from a slightly different angle. One of the great benefits of remote research is that the previously clear lines between clinical trials and regular medicine are becoming blurred. To put it bluntly, why shouldn’t a family doctor exploit the information they gather from a patient’s heart monitor the same way a pharmaceutical researcher would? But with so much information at their fingertips, Goldsack warns experts have to battle to cut through to what really matters – hardly easy when clinicians are scarce and a typical trial leaves upwards of three million data points to parse.
Trial training Fortunately, there is a solution here. By relying on sophisticated algorithms, it’s now relatively easy to divide the analytical wheat from the chaff, even with limited staffing numbers. Goldsack envisages a system that flags the unusual minority of results for
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doctors to check manually, though adds that “we can’t just shoehorn all these tools into existing workflows”. Kehoe makes a similar point. “Don’t start with the hammer and look for holes,” she says. “Start with the meaningful measure and consider whether a DHT is the best tool to capture that measure.” At the same time, both experts agree on the vital importance of cybersecurity, unsurprising when data can now be fired remotely from a host of different directions. Apart from the obvious dangers – a Philadelphia retailer of clinical trial software was hit by a ransomware attack in 2020 – Kehoe adds that conveners must be equally sure of the ethics of digitalisation, explaining to subjects exactly how and where their data will be used. With so much to consider, it’s no wonder that bodies like DiMe are battling to smooth the path ahead. In Goldsack’s case, one of her most interesting projects involves gathering together “core digital measures” for clinicians to exploit. In practice, that means looking at a range of conditions, then crafting a list of important measures to investigate. The fundamental idea is to ensure that, when scientists research something like sleep, they only keep an eye out for what really matters and avoid being drowned in a flood of useless data points. Crucially, DiMe is doing this work at the pre-competitive stage of the trial process, ensuring that pharma titans develop shared standards before rushing off to market new drugs. That’s echoed, Goldsack adds, by industry-wide training programmes. The point, she says, is to get every department of a pharma company, including unscientific ones, like legal or commercial affairs, to stop being “frightened of technology”. A noble aim – especially when it’s already clear how much devices can offer patients and researchers alike. ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
ra2 studio/
Shutterstock.com
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