Clinical data management
they’re really creating these centralised data exchanges that are global.”
The advanced technologies are still in the early stages of development – it is unclear whether all patients will be receptive.
Along with the benefits, however, there are the inevitable obstacles and challenges, and people have to be aware of these if they’re going to make the most of DHTs. For starters, “it is extremely expensive”, Shaw admits. “But once it’s built it’s so scalable. There’s this really expensive curve at the top, but it really evens out and becomes much cheaper. It’s like any new technology within a society – it’s a lot more expensive for the early adopters.” And then there are data and privacy regulations. “Those are such critical concerns,” Shaw notes, “because it can be hard to figure out where the data is going. It’s not as simple as: it goes from a phone to a hospital. The data might go around the entire world – and the question is, whose servers is it going to? Is it a consumer device? And do you consent to give it to these third-party companies who can do whatever they want with it?”
A learning curve
When it comes to healthcare, developers have to work extra hard to make sure that these technologies are safe, secure and validated – but it’s not impossible. “To us,” Sacks says, “best practice would be having well-validated systems and making sure that the technology has been verified. When different technologies are used, performance specifications may be important to ensure that they can be used interchangeably. “We have a lot of safeguards in there to make sure that things are ethical and that they’re scientifically reliable,” Sacks continues. And it’s not just the FDA that holds this view. As Shaw explains, “[there has been] a big global push for interoperability; in other words, having the same data structured the same way so that it can be exchanged. The major group doing this is called Health Level 7 (HL7), which is an international organisation that’s been pushing for years, and
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These frameworks and systems have been in place for some time now, but we’re still on a learning curve. “We’re not in the early days,” Shaw muses, “but we’re in the young days of trying to match up how the technologies have promise, but what’s the reality of how they’re going to be used?” As Sacks notes, “The big difficulty is that we don’t yet have the experience. We don’t have a thorough knowledge of how participants in trials are going to use them, how effectively they’re going to work for them. There are concerns that elderly patients may not be able to use these technologies comfortably – they may be less computer savvy. “Others may have physical difficulties, for example, patients with Parkinson’s may not be able to press small buttons. So, we have to learn about how patients will use them, how reliable they’ll be, and whether they’ll keep using them during the duration of the trial.” In a sense, then, DCTs are a kind of double trial, testing not only a drug, but a digital toolkit, too. “That’s probably where we are at the moment,” Sacks agrees. “These advanced technologies have not been used to any significant extent as the sole measurement in a clinical trial. But I think they’ll develop independence as we become more confident with them and as industry becomes confident with them.”
A bright future ahead For Zibert, Sacks and Shaw, the future of DHTs looks bright. In the next ten years, they all agree that these technologies will be widespread, not only in clinical trials, but across healthcare – but only if developers design with the patient in mind. “I think the main thing that a lot of people are doing wrong is that they make an app and then they release the app, and then they think that all is good now. That’s not the case,” Zibert stresses. “The overarching goal of Studies&Me is personalising treatment development and that is exacted by listening to the voices of the patients, and also the doctors, to ensure that they understand, they feel motivated, and that they also gain something out of the clinical trials. You cannot just make one app that fits all – you have to make an app that fits the target population of your trial.” It’s a refrain that all three echo.
So, what does a patient-centric clinical trial look like, in an ideal world? “Patient-centric,” Zibert says “is if you want to do your trial visit with the doctor when you’re at the sea. Or in a forest. You can do it where it suits you the best, where you feel that you are in the scope of being yourself.” Welcome to the world of remote health – the toolkit to the future is already in your hands. ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
yelosmiley/
Shutterstock.com
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