Marc Sebes, Vice President of Product, Validic
For clinical trials, the road to results is often long and tedious – not to mention costly and resource intensive. Four digital health technologies are now poised to enhance and streamline the clinical trial process. Whether enabling more comprehensive monitoring, increasing the frequency of data collection, or growing the pool of potential participants, digital tools can help researchers reduce costs while improving efficiency and outcomes.
Wearable fitness devices
“Wearables” are small electronic devices that are light enough to be worn or carried. Through sophisticated technology (multi-axis accelerometers), they monitor things like steps, active minutes, heart rate, sleep and so on. In the near future, they will also provide measures and insights for stress levels and blood pressure.
There are two types of wearables found in clinical trials – consumer-grade and clinical-grade. Consumer-grade are the devices with which most people are familiar – Fitbit and Apple Watch, for example. They are relatively inexpensive and easy for people to use, so they tend to fit seamlessly into participants’ daily lives. That said, the data they generate is not yet considered clinically valid, and thus can only be used in an exploratory fashion during a clinical trial.
Conversely, researchers can employ specialized clinical-grade wearables, commonly known as actigraphs, to gather primary and secondary data. Although these devices resemble their consumer-grade counterparts, they have gone through the FDA 510(k) pathway and yielded validated data. As such, regulators consider them to be reliable enough to support safety and/or efficacy claims.