Clinical data management
From their office in Copenhagen, they were able to run an entirely virtual trial, recruiting 60 patients in Canada through a prototype of Studies&Me. The study was a success, Zibert reflects, resulting in two things: “First, we could target, identify and recruit patients for the trials, and, secondly, we had a new operational model that would be completely centralised with respect to trial staff, but decentralised with respect to patients.”
Lead the way
Studies&Me is one among a number of spin-out companies from Danish organisation LEO Innovation Lab, including Nøie, KlikKit and OMHU – all mobile- based technologies that have helped to push clinical trials on to the virtual stage. And while the Danish hub is blazing a trail in Europe, the US FDA is leading the way across the pond. The MyStudies app, another platform developed for use in decentralised clinical trials, was released by the FDA in 2018. As Leonard Sacks, associate director for clinical methodology at the FDA, explains, “The MyStudies app was a customised way that we could get information directly from patients themselves. It’s a secure mobile phone app that allows us to collect patient-reported outcomes sometimes used in clinical trials.” During the pandemic, he says, “The app was actually modified to facilitate trial electronic enrolment for patients who are in isolation and can’t use standard procedures for informed consent. So it was adapted to the Covid environment and it’s there for use afterwards.” Yet, as Sacks is keen to stress, “mobile apps are related, but only to a small piece of what we’re really talking about, which is Digital Health Technologies (DHTs).” This term DHT, which the FDA is currently drafting guidance for, “includes a very broad swathe of mobile technologies”, Sacks explains, “including mobile sensors, mobile apps, and platforms for data acquisition, like cell phones and tablets.” Though there are a number of apps that help to diagnose, treat and monitor health disorders (take LEO Innovation Lab’s Imagine, which tracks treatment for skin conditions), mobile apps tend to be limited to patient recruitment – like Studies&Me and MyStudies – or informative resource platforms – like The Duke University Mobile App Gateway. As Ryan Shaw, faculty lead on the project explains, the Mobile App Gateway “is a resource for our community, where if you have questions about how to leverage mobile apps, wearable technologies, or digital health at large, our team helps to provide guidance on how you do that; how to select tools, how to select data, how that might be incorporated into a research process for a trial or to a care delivery”. In other words, as the name of the project
Clinical Trials Insight /
www.worldpharmaceuticals.net
The pandemic proved that many remote activities for clinical trials can be done.
implies, apps are a gateway into the world of DHT, but as Shaw notes, echoing Sacks, they’re “just one little piece of how data gets flowed and captured across the entire feedback loop”.
Nevertheless, mobile apps do remain an integral piece of the still-evolving DHT puzzle, helping to “democratise” virtual healthcare, as Shaw suggests. “I think that one of the biggest benefits is that this is happening across socio-economic backgrounds and across geographies.
“I felt that the way that we conducted clinical trials was a little bit too narrow and too little focused on the greater good of the patient. We just saw patients like a lab mouse that you wanted to treat. So, how could we make it even more personal?”
John Zibert
“You don’t just have to have a computer to get access to these remote data collections. And now that we can collect data from people at almost any time and anywhere, it can be much more democratised,” he says. “We can tap into tools that allow us to capture data from people’s pockets or in their home, or in their car. Same thing for clinical trials – we don’t just have to have zero months, six months, 12 months, we can capture all day long, any day. That can be excessive, but it creates brand new opportunities to have real insight into people’s lives and into what health really means. And I don’t think that can be overstated.”
60 Studies&Me 41
The number of patients recruited for an entirely virtual trial in Canada.
yelosmiley/
Shutterstock.com
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