Let’s start by defining wearables. Wearable technologies (or wearables) are items embedded with small, inexpensive electronic sensors that can be comfortably worn – such as clothing, watches and jewelry. They are fast becoming a critical tool for medical researchers and drugmakers. Bloomberg reports that according to the National Institutes of Health’s records there are 299 clinical trials using wearables.
(image from Piwek L, Ellis DA, Andrews S, Joinson A (2016) The Rise of Consumer Health Wearables: Promises and Barriers. PLoS Med 13(2): e1001953. doi:10.1371/journal.pmed.1001953)
What’s in it for pharmaceutical companies?
By providing clinical trial participants with wearables, pharmaceutical companies can gather more accurate information that could help to streamline clinical trials and support patient care. Wearables may also help pharmaceutical companies to provide drug effectiveness data to insurance companies or governments that support their treatments are effective, therefore helping in reducing unnecessary prescriptions and lowering health care costs.
Fitbit and Apple watch are just two of the many activity trackers on the market today. Both are currently capable of tracking vital signs such as heart rate, exercise and movement levels. From a drug development and early drug safety capturing perspective, the real-time data input is more accurate than human memory and could provide valuable information.
How will the latest Fitbit lawsuit impact wearable use in pharmaceutical clinical trials and should pharmaceutical companies worry? Would this exclude it from the clinical settings, where it would have an enormous potential?
Looks like the future may be murky as some wearables may be unreliable and potentially be misleading. Devices are marketed under the premise that they will help improve general health and fitness, but the majority of manufactures provide no empirical evidence to support effectiveness to their products.
Fitbit was hit in January 2016 with a class action lawsuit regarding it’s heart rate monitoring.
According to the complaint, one plaintiff had a trainer manually count her heart rate during a workout after buying her Charge HR last year. While the trainer recorded a heart rate of 160 beats per minute, her Fitbit device said her rate was at 82. The other plaintiffs cite similar experiences with their Fitbit devices.
Fitbit was also issued a recall in 2014 after customers complained of rashes after wearing the devices and lawsuit over misleading advertising.
Response from Fitbit, Fitbit trackers, are not meant to be medical or scientific devices.