Over the last few years, a lot of excitement has been generated by the use of mHealth (mobile health) technologies in clinical trials. The likes of Purdue Pharma and GlaxoSmithKline, for instance, have turned to emerging platforms, such as Apple’s ResearchKit, as they look redefine the ways they gather data. Such efforts indicate pharma’s willingness to embrace the new technologies available to them.
But in an industry notoriously known for its slow moving processes, can the use of mHealth mark a new paradigm in the way the industry operates?
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CTA spoke to Ray Dorsey, Professor of Neurology, University of Rochester, who has been a wide adopter of mHealth technologies in the clinical research he’s conducted over the years. In this interview, Dorsey feels that while the signs are promising, mHealth is yet to reach its defining moment.
Clinical Trials Arena: What are your thoughts on mHealth in the clinical trial space?
Ray Dorsey: There are two things that we’ve been most active in: first is around connecting virtual research visits. We do a lot of work in telemedicine about providing care for people with Parkinson's disease directly in their homes. I think in the future you can conduct research visits with patients in their homes. If you think about the current model where you have patients who suffer from ALS, or muscular dystrophy, for example, we’re asking them to come see us, which is backwards; we should be seeing them on their terms. As a result, we’ve spent a lot of time trying to connect with patients remotely.
The second area is around developing more objective, sensitive high frequency assessments of how people are doing. Currently with Parkinson's disease we have people come into the clinic and have them tap their thumb and forefinger as big and fast as they can 10 times and rate that on a scale of zero to four. Then we track their progress over six months to determine whether the drug or device works based on that. Increasingly, there are smartphones, wearable sensors or other devices that can provide us objective, high frequency assessments that are more sensitive than the current ones needs to be shown on participants regardless of where they are. Right now, we do our assessments at arbitrary times in artificial environments, and now we can do assessments in high frequency times in natural environments to help determine whether a drug, device or intervention is working.
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CTA: How do you see pharma companies adopting mHealth going forward?
RD: I think the industry is changing. I was recently at a conference where I asked the audience, made up of people from the industry, how many of them had used or were using virtual research studies in their visits. Out of a room of 80 people, roughly 20 raised their hands. Then I asked how many were using wearable sensors or smartphones in their clinical trials and probably 30 said yes, so I think these things are starting to be adopted. The pharmaceutical industry is largely risk averse so they're waiting for the FDA to provide great clearance for them to do this.
What’s more, I think there needs to be more evidence-based research. I think lots of these things that sound promising and conceptually seem to make a lot of sense. However, there’s a dearth of published peer-reviewed evidence demonstrating the actual value of these new tools and technologies for conducting clinical trials, and that’s what we try to do as academics, namely, to fill in that gap.
CTA: Do you feel the ability to have access to personal data poses an ethical grey area for researchers?
RD: For smartphones, when patients download our app, we’re actually quite explicit and say during the consent process (outlined on the phone) that we can't guarantee your privacy 100 percent. We also enable participants to stop their participation at any point during the study and to resume at any point in time for any reason. It’s a real concern on the one hand; for some patients, they don’t mind, but for others who may suffer from HIV, or mental health issues, they may want that privacy, and that needs to be secured. So I think depending on the sensitivity of the data, privacy is still a real consideration.
CTA: What is the main advantage of using wearable devices in clinical research studies?
RD: I would say it’s the ability to get high frequency assessments. If you think of it from clinical care, you might see a patient an hour every three months, which probably amounts to less than 0.1 percent of their life. We base our care currently on assessments on what amounts to less than 0.1 percent of a person’s life at an arbitrary time in an artificial environment. In clinical trials, however, you might get to 0.2 or 0.3 percent, but largely, we don’t know what we don’t know.
For instances, in diabetes, we didn't know about nocturnal hypoglycemia, so we started measuring it; we didn’t know about many sleep disorders until the last generation when we started watching people sleep. What’s more, with Parkinson's disease, we don't know what proportion of the day people have tremor, which is a pretty basic thing you’d want to know about people with the disease. And that's all because we've never had the means or the ability to effectively assess that. So there are a lot of things we don't know and these new tools and technologies are now allowing us to do so.
CTA: How do you envision the future of wearables or mHealth in clinical research?
RD: We're in a very early stage in using this class of tools (digital bio markers) and we think these will be incorporated into a wide range of clinical trials as a means of obtaining high frequency, objective data on how people are performing in the real world. We’re on a path where these new tools will allow anyone anywhere to receive care, anyone anywhere to participate in research, and anyone anywhere to benefit from the resulting therapeutic advances.
