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Wearables in Clinical Trials

by Melynda Geurts
wearables

To Wear or Not to Wear is the Question

Wearable devices have taken our society, and the clinical research industry along with it, by storm. The immediate access to data makes researchers drool.  While technology is moving at lightning speed, we must be careful not to get too wrapped up in the hype until we fully understand how we can incorporate this game changer in clinical trials.

Companies like Google, Apple, IBM Watson Health are all partnering with major pharmaceutical companies to evaluate how to engage their products in data collection of an individual’s health status, not just in the commercial realm, but in R&D as well. Biogen, for example, recently used fitness trackers to gauge study participants’ movements to better gauge their response to the compound.  Moreover, with the launch of Apple’s ResearchKit in 2015, all eyes will stay focused on how health related apps may revolutionize the clinical trial paradigm. Whether we wear it or carry it, technology will change how we receive medical treatment across all platforms.

With all that said, not all is rosy where wearables are concerned.  There are still several issues to be worked out when it comes to incorporating wearables into clinical trials.

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The unique identifiers broadcast by all studied devices except for the Apple watch are fixed. These static identifiers enable third parties, such as shopping malls, to persistently monitor where fitness wearables are located at a given point in time.

 

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Engagement

Keeping study volunteers engaged will be a key issue: a study by Endeavour Partners found that more than half of people who have owned a wearable tracker no longer use it. Furthermore, a third stopped using the device within six months of receiving it.  Simply providing a device to patients or allowing them to use their own during a trial will not be enough.  Trial organizers will need to come up with creative ways to keep participants engaged and motivated to continue using the devices.

Ethical Issues

Wearables are easily transferred to another.  Will companies be able to decipher this and how can data remain credible if this happens?  Indeed, there are trials where participants are being given fitness trackers to see if they are fit for a particular treatment.  If a person gets a wearable and wants to insure that they are “active enough” to receive a perceived benefit or course of treatment, what’s to keep them from giving it to someone else to ensure they get in?

Data security and informed consent.  There has been a wealth of information released by makers of fitness trackers lately on everything from male vs. female sleep patterns to the ability to predict a woman is pregnant.    Sure, the makers of these trackers are using the data “anonymously” but he fact that they are collecting it at all is somewhat troubling and it can’t be too hard to correlate data to a specific device if they so choose.  Have these users been given the option to opt out?  Indeed countries are approaching these questions with differing results.  An article from Susan Shelby, PhD which appeared in Applied Clinical Trials recently highlights the data privacy issues between the EU and the US with the revocation of Safe Harbor.  U.S. companies generally are allowed to commercially share data, provide it to authorities, or even sell it because it is classified as “fitness” information as opposed to “health” information. Data for clinical trials could be even more troubling.  Will device manufacturers know what devices are participating in a trial?  Will they have access to that data in addition to the sponsor?  With the increasing capabilities of wearables, at what point does fitness data become health data?  What about participants?  If they are provided with data showing average results, will they try to improve or “win”? and what will this mean for the validity of study data?  Indeed these are likely some of the questions the FDA had when they requested comments at the end of 2015 on BYOD and technology use in clinical trials. (See Using Technologies and Innovative Methods to Conduct FDA-Regulated Clinical Investigations of Investigational Drugs.  The link will take you to all submitted documents and comments)

A recent study by Canadian nonprofit Open Effect studied the security and privacy of many popular wearable devices.  Their findings-“the unique identifiers broadcast by all studied devices except for the Apple watch are fixed. These static identifiers enable third parties, such as shopping malls, to persistently monitor where fitness wearables are located at a given point in time.”  They also found other security vulnerabilities exist and that data could be falsified by someone interested in doing so.

The Bottom Line

While the promise of wearables  is extremely intriguing and exciting, we must proceed with caution and take steps to not get carried away.  Steps must be taken to insure privacy and data viability.  What that exactly means, I don’t know, it’s yet to be determined, but we all will have a voice in shaping debate and results.  I can’t wait to see how this shakes out.

 

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