Number of clinical trials to use wearables nears 300

In recent years, the use of wearables in clinical trials has gone from being an attractive but untested idea to an emerging part of the research toolkit. Now, Bloomberg has tallied up just how many trials are building the devices into their protocols: 299.

The figure comes from National Institutes of Health records and, depending on the completeness of this resource, could be lower than the actual number. To date, many sponsors have limited the use of wearables to pilot trials to test the effectiveness of the devices themselves, not the pivotal studies that make or break their businesses. Even with this caveat, the rise of wearables has occurred quite quickly given the industry's reputation for taking a slow, conservative approach to the adoption of new technologies. Fitbit, one of the wearable pioneers, was only founded in 2007.

"What a lot of these consumer-focused companies have done is made pedometers and sensors easy to wear," Kara Dennis, mobile health chief at Medidata ($MDSO), told Bloomberg. "They look cool, they're slick, they have long battery life, they're light." Battery life is a key consideration for sponsors. A wearable will only generate useful data when it is worn, and the likelihood of participants failing to do so rises if they have to take it off frequently to charge it. Data quality is another outstanding doubt, but, given the well-known problems with patient-reported outcomes, isn't necessarily a killer blow.

Some companies are handling the data-quality doubts by waiting for clinical trial-grade devices--Google ($GOOG) is working on one such wearable--while others are figuring out if they can live with mass-market consumer products. There are doubts about the viability of the latter approach. "I can sit in my armchair at home swinging my wrist and it says I've walked six miles," Trevor Jones, chairman of CRO Simbec Research, told The Financial Times. Such concerns could stymie the use of devices in key trials, the data from which regulators and payers must take seriously if the study is to be a success.

- read Bloomberg's feature
- and the FT piece (sub. req.)

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