Jan23

The Potential of Wearable Technology in Clinical Trials

Wearable technology has exploded in popularity over the past few years amongst consumers. Devices such as the Apple Watch or Fitbit device have been seen through the lens of an exercise or fitness tracker. These devices have complex sensors that can be effective enough to be used in a clinical trial which has the potential to not only increase participation in clinical trials, but increase the efficiency and volume of the data being collected as well.

The early application of wearables in the healthcare community can bring a variety of benefits to research sites and clinical trials. Some of those benefits include:

  • Continuous monitoring of a patient’s health by tracking vitals and other statistics
  • Accurate data collecting to improve patient-reported outcomes
  • Reduce costs by decreasing the number of in-clinic patient visits
  • Improvements in subject retention

Patient recruitment has consistently been an issue for research sites, and continuing to grow the database of qualified participants can significantly impact a trials data. Even though physicians are aware on-going clinical trials, it is impossible to know about each specific study and if their patients qualify. Using wearable technology and participating mobile applications like the ResearchKit from Apple can increase the awareness of multiple clinical trials.  If more potential patients are aware of the trials they qualify for, participation would increase and improve the accuracy of the data being collected.

By monitoring patients with wearable technology, research sites could reduce the number of in-clinic patient visits. Patients would no longer need to schedule an appointment to monitor their vitals or other important statistics for the trial; their information would be constantly monitored by the wearable technology, with the data being sent directly to the research site.

One of the clinical trials currently being conducted with a wearable device is the epileptic seizure study through Epiwatch, available through the ResearchKit from Apple. Epiwatch, with John Hopkins University, has given participants the ability to track the onset and duration of epileptic seizures in real time using the Apple Watch. If the patient starts to feel the effects of an oncoming seizure, they can tap a custom complication on the watch. This alerts the accelerometer and heart rate sensors and a notification is sent to a designated caregiver. By utilizing the Apple Watch technology, researchers can efficiently track the length and frequency of their patient’s seizures in real time.

Despite the clear benefits most wearable technology is still seen as a consumer product, they are not regulated by the FDA. For these devices to be used more heavily in a research capacity, the data collected would need validation and FDA approval. Even so, the clinical trial industry is on the brink of bringing in technology that could be a groundbreaking move forward in research studies of the future. Broad consumer use of the wearable technology is improving the familiarity of the products and its future implementation in clinical studies.


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