B.Y.O.D — The Next Pharmacovigilance Trend in Clinical Trials.


Next time you’re sitting on the subway or commuting to work take a look at the wrist of the person next to you. Odds are, you’ll see a Fitbit or Smartwatch. In fact, odds are you have one on yourself. Besides letting you feel like James Bond when you answer a call, these devices are constantly collecting data about your health. Current devices are tracking data such as your sleep cycle, calories burned, and heart rate. As more advanced sensors are integrated, the list of possible metrics can include anything from your blood-glucose level to specific brain activities. This level of reliable data tracking can be utilized for better pharmacovigilance in the clinical trial cycle.


Dr. Sam Volchenboum recently spoke at the Evolution Summit about the opportunity for wearables in the clinical trial cycle. The full presentation can be found in Litmus Health’s article here. But, I will outline the benefits below:

  1. B.Y.O.D (Bring your own device) can increase subject compliance and retention — The idea is that using your own device is so easy that why not? It is often preferred over wearing a bulky heart monitor or inconvenient monitoring rituals.
  2. Better Data — Recall bias is incredibly prevalent especially when reporting physical activities. Additionally, the low-to-moderate-to-severe scale is ambiguous and leads to a poor agreement between clinicians and subjects. However, wearable collected data does not lie nor forget, and is clear. The sensor data can also be cross-referenced with ePRO data for deeper insight into patient outcomes.
  3. Lower Variability in Data — Lower variability = fewer subjects needed. Better statistical confidence makes the process more streamlined, reliable, and cheaper.
  4. Data Flow — The data is objective rather than subjective in nature like traditional clinical assessments. The ease of data transfer also lowers the burden on patients and leaves a transparent audit trail.

Dr. Volchenboum goes on to address the challenges of incorporating wearables into the clinical trial cycle and lists the considerations to keep in mind. The challenges are of no surprise and include concerns about device accuracy, privacy, and security. The concerns are consistent with any medical device on the market, and are surmountable. Dr. Volchenboum believes the clinical trial industry is ready to integrate wearables. I believe the technology has the potential to make pharmacovigilance easier and more accurate.

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