MEDICAL DEVICES
collected, where’s it going, and what it’s being used for. That understanding of the data is important and at that point, the processing and security can be considered. In our system, we try to avoid identifying patients along the data chain as much as possible, patients will be a unique identifier, a string of numbers and letters. When it gets to the site or sponsor, they can work out which patient it relates to using the identifier.
AB: How have sponsors reacted to the potential use of patient’s own devices in trials?
SL: The value proposition is different depending on the study but overall, I think what sponsors like is the fact that they can get access to a richer set of data that will improve their R&D process, whether it’s at the early phase stages or later phase stages. It is important for sponsors to be comfortable implementing something like this as part of their protocols and trials. We basically abstract the technology for the sponsor so from their perspective, they just get a data service from us while we worry about all the nuances and logistics of it working correctly. One concern from sponsors is what they do
with all the data because it is almost too much data. The sensors generate data, but that doesn’t mean it all needs to get processed. In
“The number one challenge with remote patient monitoring in any setting is getting the patients to use the device correctly”
the workflow design, you decide what type of data you’re trying to capture. I also think AI can help here with its ability to process larger amounts of data.
AB: Do you think that patients using their own devices will become the norm in clinical trials?
SL: The patient reported symptoms are growing in trials and healthcare but it is either sometimes not timely, or not accurate. By adding in sensors, you have quantified data which can correlate with patient-reported symptoms to support some of those reports. As a result, I think they will be used more and more in time.
Credit: DenPhotos via Shutterstock. Outsourcing in Clinical Trials Handbook | 45
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