Outsourcing
With new wearable and app-based technology, decentralised trials can support more patients and record data more frequently.
the burden from the patient. To find a hybrid model [that works for everyone], I think is absolutely key.”
Digital support
Also key is the need to consider the ability of each patient group to manage technology. Patients with neurological or degeneration symptoms, for example, are a case in point for Dalsgaard, given Lundbeck’s focus on brain health.
“Some devices you have to wear – maybe it’s an app on a phone, you may need two devices or to install it on different platforms. There are of course challenges to that. If it’s a severe Alzheimer’s patient, you cannot ask them to sit down with an application and go through a cognitive test. So, there are very practical issues around tech.” However, he says exciting devices are constantly coming to market that offer solutions to support patients with even the most challenging symptoms. “We work with a company that has a sole in the shoe that measures gait. The assessment is independent of the patient, so you can have it even if you’re impacted cognitively. So, it’s a very broad picture in terms of technology.” The advent of this kind of wearable and app-based tech means that the amount of data collected over a 24/7 period is greater than that during outpatient visits. Dalsgaard says e-diaries, sleep trackers and other wearable and non-wearable tech can provide valuable data if integrated into an effective trial design. “There are some things you can do in the home that you cannot do in a clinic,” he says. “You can sample it much more frequently. You can control the variation and get a much more precise picture. You don’t necessarily want to replicate what you’re
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already doing – you want to really tailor it and make it exploit the opportunity in a decentralised setting. It would be a way of measuring data that you would not get through normal conversations.
“Digital devices are currently supplementary – they are not carrying the whole load of the trial yet.”
Move in the right direction Further integration is the next inevitable step. That next push will largely depend on buy-in from regulators – and Dalsgaard remains upbeat about future approvals for trials that rely primarily on virtually collected data. “It’s a moving target, but it’s moving in the right direction. I think, generally, everybody is sensing that this is a direction we’re moving in and we have to work together to make it happen. Regulators are approving digital therapeutics – if they’ve come that far in embracing digital, I don’t think that the distance to acknowledging that an element of a trial can be a digital device that can provide a primary endpoint is that far away.” Dalsgaard says, ultimately, this should all lead to getting treatments to market faster – and possibly more cost-effectively. “You can deduce the logic out of it. If you are not limited to a few clinical trial sites, but you can access a broader patient group who then stay in the trial because it’s easier for them and you get better data that can be objectively assessed, then all that ties together to drive more efficient and effective clinical trials,” he says. “You still have to go through the same steps, the regulator will require you to de-risk and replicate, and so forth, but on the whole that adds to the probability of success and speed, and maybe even cost savings.” ●
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