Looking Forward: Wearables in Clinical Trials and Post-Approval Programs

mHealth wearables in clinical trials

Looking Forward: Wearables in Clinical Trials and Post-Approval Programs

In my previous blog post, I discussed the definition of mHealth and how current technologies can be used to assist in clinical trials and post-approval programs. I recently returned from this year’s mHealth Summit in Washington, D.C., where the focus was not only on mobile applications and expanded communication to patients, but on wearable trackers. Wearable trackers have seen a boom in the last several years. At the conference, industry leaders discussed the current technologies available and how pharma may integrate these tools in a more impactful way in the clinical trial space.

What is a wearable? 
Wearable technology is simply anything that is worn (on the wrist, clipped to a belt, even imbedded in clothing) that contains sensors that pair with a web connection or Bluetooth to connect wirelessly with a user’s smartphone. We’re all familiar with consumer devices such as Fitbit®, Apple Watch®, and Mi Band®. While these devices are seen as “just” exercise or fitness trackers, don’t be fooled. Many wearables contain sensors that are just as sensitive and accurate as those found in clinical settings. With this technology at our fingertips, one might feel that these wearables and the data they collect can be leveraged in the clinical trial setting and used by physicians to help make medical care decisions. 

Not so fast
While other industries are making huge strides by using sensors to study changes to the human body or how to better engineer cars for safety (Scott Kelly’s yearlong space mission for NASA®, Nascar’s crash test sensors), pharma is behind on this front for one main reason: The majority of current wearables are considered consumer products. As such, they are not heavily regulated by the FDA because they do not pose a risk and generally are utilized to encourage a healthy lifestyle. Now that consumer wearables are widely used by people of all ages, the data needs to be validated and FDA-approved for use in clinical trials. Some estimates predict we are still up to two years away from wearables making a huge impact in the trial space.

On the horizon
Some companies are ready to help the industry play catch-up and are developing “next generation” type sensors. They hope to prove that the data obtained from these wearables should be considered the gold standard. Wearables such as those being developed by Google[x] (the “secret” division at Google that is also piloting the driverless car) is said to be working on a wearable tracker that is built specifically for clinical use. Additionally, industry leaders hope that current technology can be validated to use for common clinical trial assessments, such as the six-minute walk test. 

The FDA will most likely be overwhelmed with all the wearables and data to review. It is important for developers and the life science companies that they partner with for pilots to develop tools that will truly impact clinical judgement. Getting to this next level will be ground breaking and I am very excited to see what the future holds in the wearable space. Paired with the current mHealth uses in patient recruitment and retention as well as the Apple's ResearchKit this makes for a very exciting future!

Contact us to start the discussion of how UBC can assist your trial in maximizing the current mHealth tools or partner with your company in pilot trials for your next-generation wearable!