Are Wearables Improving Clinical Trials? The Jury’s Still Out.

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Mobile health devices, specifically wearable technologies, have the potential to shift the way we approach health and wellness. While these technologies are rapidly growing in number, the implications for clinical trials remains undetermined. Wearables include any kind of device that is worn in some way, whether as a watch, clip-on device, or belt, that acts as a sensor and links to an individual’s online data system. Fitbits have become ubiquitous, but it is difficult to utilize such large swaths of privately collected data to understand the value and efficacy of these technologies. Even though activity trackers, like pedometers, have been used for over a decade, we have entered a time when that data can be electronically captured and stored remotely.

While these technologies allow researchers and care providers to track a user’s exercise, assess risk factors, and measure compliance, they are still not regulated by the U.S. Food and Drug Administration (FDA). Wearables are considered consumer products given that they pose little risk to consumers. In December of 2016, a FDA announcement stated that consumer wearable devices can be utilized in clinical trials if those devices are “fit for purpose.” While the FDA does not oppose use of wearables, the problem of wearables’ accuracy, and therefore efficacy, remains. Studies have suggested Fitbits are generally accurate for step count measures, although there is less evidence that Fitbits are as reliable for other measures, such as energy expenditure. Many of these studies are not generalizable given the samples fall into the W.E.I.R.D. subset of the population—participants are Western, Educated, and from Industrialized, Rich, and Democratic countries. This is a problem because the study results only apply to similar individuals, therefore Fitbits may not be accurate across more diverse populations.

Ironically, despite the fact that there have been few large, generalizable clinical trials of an unbiased nature assessing wearables, these devices are changing the landscape of current clinical trial practices. It is now easier than ever to locate the ideal sample and simply send the individuals wearables to assess lifestyle or a smart-blood pressure cuff to report data immediately back to the research database. This will greatly increase the speed of clinical trials, while also reducing costs. For example, a smart blood pressure cuff is cheaper than an extra doctor’s visit and will likely result in decreased attrition given that is much easier to complete the study while the participant is at home. While there are numerous benefits, drawbacks remain: the technologies themselves are not all thoroughly assessed and these devices can collect an overwhelming number of data points to synthesize. Additionally, studies have shown that continued use and patient engagement with these technologies often does not last longer than a few weeks overall.

Large scale trials leveraging wearable data, along with other participant information, are looking at other factors related to health as well. Beyond overall accuracy of wearables, studies are evaluating how individuals who track physical activity might be more likely to adhere to medication. As long as there are technological advances in how we assess and manage our health, there will be plenty of challenges in how we conduct clinical trials in the future.