2 September 2016

What the Fitbit lawsuit means for the clinical research profession


“Actigraphy” or “biotelemetry” – whatever you call it, the clinical data collected by wearable devices such as the Fitbit has been the subject of intense interest from medical researchers. They want to study how wearable monitors, mobile apps and biofeedback can be used in innovative ways to inform patients, measure clinical indicators and improve health.

What the Fitbit lawsuit means for the clinical research profession

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Therefore, it’s not the best news that Fitbit has been hit with a class action lawsuit alleging that heart rate data from the device is inaccurate. Researchers found the margin of error could be as high as twenty beats per minute.

Gulf between consumer users and clinical researchers

Wildly popular with consumers, wearable devices haven’t really been subjected to the kind of rigorous analysis that researchers apply when investigating the validity of data in clinical studies. The data series from these devices sometimes lack valid time stamping, making them difficult to analyse robustly. The data packages also vary from one device to another, making comparative studies difficult.

The FDA is attempting to bring some structure to this area by issuing guidance on standards for submitting electronic data as part of a study. This should bring some standardisation to the field.
A new generation of wearable monitors is on its way, with Google about to launch a version of its own. What companies like Google now have to do is decide on the appropriate balance between usability for the wearer and accuracy of data recording and analysis.

Modelling errors as part of the results

These wearable monitors can produce huge amounts of very diverse data. The challenge is to collect the data from the proprietary device bought by the user, validate it, model it and use it in the clinical research setting. A pharmaceutical services provider such as G and l scientific will be well aware of the need to manage this data requirement.

However, there seems to be a feeling among the clinical research community that these devices will progress, with more sophisticated sensors able to deal with more diverse environments. The data collected will be subject to more standardised handling techniques, and errors will be accurately modelled so that it will be easier to normalise the data and make comparisons across devices.

Despite the Fitbit lawsuit, wearable monitors and their companion apps aren’t going away.