Wearable sensor devices are an essential element for data collection. As their use is rapidly growing, so is the debate whether consumer or medical-grade wearable sensors are fit for purpose in clinical trials.
“There is a lack of understanding with the consumer-grade sensors and what they can actually do. I think because you have an Apple watch and you see the data it collects, a lot of people without knowledge think, okay well, there’s enough data on my Apple watch to do something with” - Dudley Tabakin, CEO, VivoSense.
Here are some things to consider when deciding if consumer-grade wearables are appropriate for your research initiative.
Good Data is Crucial in Medical Research
Datasets captured using wearable sensors can be some of the most complex used in health research. If the end goal is to provide evidence in regulatory decision-making, data quality and fidelity are essential. Consumer-grade wearables are generally designed for personal data capture rather than for research. The quality of collected data may be adequate for an individual’s health management; however, it may not be ideal for specific regulated clinical research purposes.
Frequent Upgrades Create Excessive Variables
Sensor development and technological advances necessitate relatively frequent changes to the algorithms applied to data in consumer-grade wearables. There are no universal guidelines for algorithms used by manufacturers to calculate outputs like heart rate, steps, calories, and distance. With new models being released with updated features every few years, the continual changes generate considerable variations in the collected data.
Not All Wearables Are Created Equal
Validation of medical-grade wearable solutions spans layers of hardware, software, and analytical procedures. For these reasons, validation is optimally completed within a well-defined use case. When evaluating the suitability of a solution for your study or planning a validation study, it can be helpful to start with the end in mind. For example, who is your study population, how will they wear/use the device, and in what setting will they be studied?
Consumer-Grade Wearables Do Have a Place in Research
Medical-grade wearables may be prohibitively costly for large study groups. Consumer-grade activity trackers have the potential to allow for considerably larger, population-level measurement of physical activity.
“You can use consumer wearables if you're doing a study with hundreds of thousands of people and the inaccuracy of the measures and missing data can be washed out by sample size. At that point, you can use fancy math to solve your bad data problem. So if that’s the project that pharma is working on, then sure they can use a consumer wearable, but in a 100-person phase 3 trial, no, they can’t rely on consumer-grade wearables.” – Kate Lyden, PhD., Chief Science Officer, VivoSense.
With the growing number and diversity of wearable sensors available today, making the right choice may seem difficult. Clinical researchers can capture excellent data from sensors not approved for medical use with the proper protocol design, data collection plan, and analysis. Data collected with this care and discipline will withstand the most rigorous academic and regulatory scrutiny.
To learn more about selecting a wearable sensor that is fit for purpose for your clinical research, talk to one of our experts.