Mark Shapiro is the vice president of clinical development at Clinipace.

I had the pleasure of speaking with Zach Brennan of Outsourcing-Pharma on the role of wearable technology in the conduct of clinical trials. According to Zach’s story, Google’s life sciences group is developing a wristband dedicated exclusively to tracking clinical trial participants’ vital signs and other data, and is looking to test the device’s accuracy in trials this summer.

Do wearables provide clinical-ready data?

As Zach noted, while preliminary testing of the device accuracy is an important first step, I concur that wearables simply don’t yet offer “the type of quality data that’s necessary for a trial.” As I mentioned to Zach:

“At this point consumer wearables don’t give you medical or diagnostic-quality data, so none of them are close to being used for primary endpoints. Until you start collecting this data, perhaps as a pilot test in some clinical trials, you’re not really going to know to know its potential value.”

Can we do a cost-benefit analysis of wearables in clinical trials?

My sense is that most CRO and pharma companies are thinking about how to incorporate information from these devices into a clinical trial data feed. On one hand, there is a debate as to whether we need all of the information that can be provided from a wearable device. For example, does continuous heart rate information during a trial tell you more or less than a weekly ECG? On the other hand, until you actually collect the data, you really don’t know if it will give you some valuable piece of information pertaining to the safety or efficacy of the drug or device under study. That being said, I think we’re still far away from being able to do a clear cost-benefit analysis of wearables in clinical trials.

With cloud-based applications come data standards and security issues

My personal feeling is that wearables are the hot technology of 2015, and perhaps will show similar growth to the growth of smartphones a decade ago. If the technology takes off as I expect, it will be a matter of simply getting approval to access the trial subject’s data from the cloud-based application.  I expect that data integration with cloud-based applications will be one route to bringing this data into an eCRF. I would expect that CROs or the eClinical companies that support them would need to work with vendors like Fitbit, Jabra, Apple, Google and others to integrate, in a secure way, the cloud-based data storage generated by their wearables. This raises issues of data standards and privacy/security that need to be worked through and are particular within clinical research, especially in global projects.

How do we analyze data extracted from wearables?

As Zach points out, there are also still questions around the data analysis of what is collected through wearable devices. As I was quoted in the article:

“Today, longitudinal data analysis in clinical trials is concerned with a specific test at ten or twelve time points. When you have continuous heart rate data for twelve weeks, we as an industry will need to start thinking about more complicated pattern analysis. I think there is some trepidation that if you collect the data, you are obligated to search it for signals. Right now, it isn’t clear how exactly to do that. In fact, this is an area I expect we’ll see the industry asking for more guidance from regulatory authorities in the near future.”

In what types of trials are wearables most useful?

Right now, the data collected is mostly related to activity, sleep, heart rate, and possibly oxygen saturation.   So, the logical start would be “trials in insomnia and perhaps outpatient cardiovascular trials…they may be generally useful for monitoring cardiovascular safety of drugs in other therapeutic areas as well.” In addition, the experimental Google wristband currently records pulse, heart rhythm, skin temperature and environmental information like light exposure and noise levels.

Already, these devices may provide a great deal of information for epidemiologic studies, which historically rely on patient reports about their diet, sleep habits, etc. Perhaps these devices could open up new avenues of drug development. For example there are genes associated with a greater propensity for exercise. One could envision developing drugs against these targets that encourage patients to exercise and measure patient activity in a naturalistic way using a wearable device.

As new and more sophisticated features are added, these devices could play a huge role in the future of clinical trials.

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