Wearables: The New Horizon for Collecting Clinical Trial Data

In Clinical6 by Brandy ReedLeave a Comment

According to a recent article by Business Insider, in just a few years there could be more people using wearable tech devices than there are in the US and Canada. The wearable tech category is estimated to grow from 21 million units in 2014 to 150 million units in 2019, a 48% compound annual growth rate. In addition, this growth will largely be fueled by wrist wearables, like smart watches and fitness bands. With advances in sensor technology, microelectronics, and the rapidly increasing popularity of wearable devices, many new opportunities in the life science and clinical industries are emerging. Wearable sensors have the capability to completely revolutionize the way we gather data and how we conduct clinical trials.

Wearable electronics, or wearables for short, are small electronics with embedded bio-sensors that can be comfortably worn on clothes or on the body. Wearable technology allows for continuous bio-monitoring without any manual intervention, thus reducing costs while contributing improvements in the quality of the data. Some of today’s most popular wearable electronics include Fitbit wristbands, Google and SONY glasses, and the Apple Watch.

The capabilities of wearable technology is only expanding. In a previous blog post, Advances in Data Collection through Mobile Technology, we briefly discussed some of the new and innovative ways wearables and smartphones are contributing to data collection using clinical trial software. The capabilities of smartphones are now being integrated into smartwatches (i.e. the Apple Watch). These smartwatches have the advantage of being in touch with the user’s skin continuously for potentially continuous physiological assessment, providing insight into the wearer’s heart rate, oxygen, and temperature readings. Smartwatches also provide real-time data that can precisely identify a range of activities as well as estimate energy expenditure. Other wearable devices and sensors connect through smartphones or directly to the internet, through either Bluetooth or a direct connection, providing another point of real-time data.

For example, let’s examine the Apple Watch. Currently, its bio sensors are pretty basic and include a four-ring infrared optical sensor to measure heart rate; an accelerometer to measure balance, sleep pattern, gait, and activity level; a microphone to analyze speech impairment; and a speaker to test hearing. Also certain functions provided by the iPhone, which is required to enable many features on the Apple Watch, can collect additional data, such as distance traveled using the GPS. Even with the basic sensors currently in place with the Apple Watch, researchers are able to gather an abundant amount of information about the patient’s day to day life. With the growth of this technology, the possibilities for data capture are limitless.

If your trial requires data tracking beyond the basic activity, oxygen, temperature, sleep, and heart rate readings, sensors are also being developed for targeting specific information or medical conditions, such as diabetes and asthma. For example, researchers have developed a portable electrocardiogram (ECG) system for high-risk cardiac patients. It uses smart phones linked to heart monitors to transmit heart rhythm data to health providers. Software then analyzes the ECG waveforms for possible abnormalities. Although this technology is fairly new, the potential of new innovations in clinical trials is boundless.

In addition to the vast amount of data provided to researchers and physicians, this type of tracking technology is often more accurate than human memory collected from subjective questionnaires. The life science industry can now gather new kinds of objective and quantitative data through mobile devices and activity trackers. This provides a real-world, real-time measure of patient physiology and how a drug affects quality of life – an increasingly important measure for pharmaceutical companies, regulators, and insurance companies. Evident in something as simple as the six-minute walk test, which has been used for years in clinical trials involving cardiovascular, respiratory, and central nervous system diseases as a valid proxy for disease severity. While there is nothing inherently faulty with this method, there is greater potential in wearable devices to provide physicians and researchers with richer data than a six-minute test.

Wearable technology and bio sensors can also significantly diminish the burden on patients. Remote patient monitoring can significantly reduce the number of times a patient will need to travel to a clinic and provide a better, fuller picture of physiological data needed to measure a drug’s impact, minimizing testing on patients. Implementing wearables and bio-sensors would not only lead to increased data, but would also reduce interruptions in a patient’s day through remote monitoring. This technology could therefore improve the patient experience in clinical trials at large.

Here at Parallel 6, we are passionate about improving clinical trials through advanced clinical trial software. Our platform, Clinical 6™, provides the opportunity for conducting a remote clinical trial and advances in data capture through our mobile platform and the integration of wearable technology. If you would like to learn more about Clinical 6™, please visit our website and request a demo.

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