Wearables in Clinical Trials: It’s About Correlation and Context

Wearables data are providing drug developers with meaningful trial participant insights that go beyond a count of steps taken.
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By Validic
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By: Jennifer Plumer, Director of Marketing at Validic

Advances in the sensing technologies that are embedded in wearables have enabled a growing array of available data endpoints, making wearables an increasingly valuable tool in drug development. Many of the early examples of wearables in clinical trials analyzed the exact output: number of steps taken or number of hours slept. However, researchers can glean more valuable insights from wearables data than just the number of steps taken in a day.
 
Wearables data become much more interesting when activity and sleep data are correlated with other data being collected, inside and outside of office visits. This correlation can provide context as to why activity, sleep or heart rate levels may have fluctuated. Sponsors can then uncover important patterns such as a participant being less active on days that a medication dose is missed or a participant sleeping more after taking the medication, indicating drowsiness as a possible side effect.
 
Wearables data can also serve as a useful indicator of behavioral health, providing researchers with a more objective means to understand how a participant may be feeling while taking a drug. Since we know there are close correlations between activity and sleep levels and depression and other mental conditions, wearables data can help researchers identify early signs and intervene accordingly. For example, a researcher can be alerted and proactively intervene if a participant begins sleeping more and becomes less active when taking a drug. These insights can be especially useful for manufacturers of drugs that have an increased risk of depressive or suicidal thoughts.    
 
But it’s not just the endpoints from wearables that enable drug developers to gain these holistic and objective insights. The game-changing benefit that wearables provide is the continuous, real-time and passive collection of data from participants.
 
“Most of the measures [wearables track] are relatively novel, not so much in the sense that we haven’t measured these things before, it’s just that we haven’t measured them with this frequency, this continuity and in the outpatient space,” said Zubin Eapen, M.D., M.H.S., assistant professor of medicine at Duke University Medical Center and investigator at the Duke Clinical Research Institute.
 
In addition to understanding how a drug is impacting participant behaviors like sleep and activity levels, wearables are also helping researchers to understand how participants’ behaviors impact a drug’s efficacy. Researchers traditionally haven’t had a way of knowing about lifestyle changes between office visits unless a participant reported it. However, the continuous collection of data from wearables is providing more insights into this. For example, wearables can provide intra-day data so researchers can see not just the total number of steps taken in a day, but also the peaks in and duration of activity throughout the day which can be an indicator that a participant started or stopped an exercise program. The researcher can be alerted and determine what, if any, effect it has on the condition and the drug’s performance.
 
As we transition from episodic to continual data collection and drug developers increasingly recognize the benefits of wearables data beyond number of steps taken—the number of clinical trials utilizing the devices will grow significantly. A recent research report from Validic supports this, finding that 97 percent of pharma and CROs plan to utilize digital health technologies in trials more over the next five years.
 
And as more and more trials begin using digital technologies, we will continue to see new and interesting applications of wearables data emerge. When correlated with other clinical data, the power of wearables data is endless and stands to transform not just the drug development process, but also our understanding of disease states.
 
About Jennifer Plumer:
Jennifer is the Director of Marketing at Validic, the industry’s leading digital health platform. Validic connects actionable data from fitness and sport wearables, clinical devices, biometric sensors and mobile applications to healthcare, pharma, wellness and sport companies. Jennifer has more than ten years of experience building and executing strategic go-to-market and demand generation plans for B2B companies.