And unlike the consumer devices and apps from Apple, Fitbit and others, Google is looking to test its device’s accuracy in trials beginning this summer.
The preliminary testing of the device will be an important step in getting it into the hands of patients and companies running trials as current consumer wearables don’t yet offer the type of quality data that’s necessary for a trial.
“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,” Mark Shapiro, VP of clinical development at CRO Clinipace, explained to Outsourcing-Pharma.com. And “until you start collecting this data, perhaps as a pilot test, in some clinical trials, you’re not really going to know its potential value,” he added.
There are also still questions around the data analysis of what is collected.
“Today, longitudinal data analysis in clinical trials is concerned with a specific test at ten or twelve time points,” Shapiro said. “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 industry asking for more guidance from regulatory authorities in the near future.”
In terms of what types of trials wearables will be most useful for, Shapiro said he thinks that “with the current feature set, sleep tracking, heart rate tracking, even oxygen saturation, are amenable for 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.”
The search engine company plans to work with academic researchers and other unnamed drugmakers to test the device and seek regulatory clearance for its use in the US and Europe, Andy Conrad, head of the life sciences team at Google, told Bloomberg News. Google may also look for a manufacturing partner, Conrad said.
In addition to pulse, heart rhythm and skin temperature, the experimental wristband can record environmental information like light exposure and noise levels.
Google has been relatively active in the wearable space recently, as the Internet giant previously partnered with Biogen Idec on a multiple sclerosis project tracking patients’ disease progression. The company also partnered with Novartis to develop a contact lens that can monitor glucose.
Novartis, meanwhile, forged an alliance with Qualcomm to collect chronic lung disease patients’ data via smart phones and a cloud-based platform.