Highlighting the advantages of wearables in clinical trials
Following on from our last article on wearables (Wearables – Opportunities and challenges for clinical trials), we will point out the various benefits of wearables in clinical trials in future newsletters.
Profiling physical activity of participants with wearables
One major advantage of wearables is that they can be used to profile the physical activity of participants. A number of the consumer-based (e.g., Fitbit, Garmin, and Polar) and research-grade (e.g., ActiGraph, activPAL, and SenseWear) activity tracker brands have been used in various medical research studies, which have shown high levels of accuracy in monitoring physical activity. Many manufacturers offer an application program interface (API) to assist programmers with extracting and using their data. The benefits of using wearable activity trackers are consumer friendliness,allowing user feedback on activity status, and enabling real-time and remote monitoring of participants’ physical fitness during or prior to clinical research. They are either clipped to clothing or worn on the wrist, and users connect their tracker through a computer or smartphone. This kind of wearable is equipped with different sensors (e.g., accelerometer, GPS, gyroscope, barometer, and altimeter) and algorithms, which are used to determine the output of these activity trackers, including step counts, distances traveled, and activity intensity.
Accelerometer-based endpoints are part of many other measures (e.g., ECG, heart rate, heart rate variability, sleep, glucose monitoring, and peripheral oxygen saturation) from wearables that enable decentralized clinical trials to build a more accurate picture of each participant’s health and give insights into the activity health of participants between in-person visits. At the same time, validated digital endpoints could eliminate the burden of complex in-clinic assessments, such as timed walking tests, or the need for patient-reported outcomes (PRO). For example, the short form of the validated questionnaire “International Physical Activity Questionnaire (IPAQ-SF)” is used to assess physical activity in clinical research. In one study, patients with cancer participating in a lifestyle intervention during chemotherapy self-reported 366% higher levels of physical activity (IPAQ) compared with objective measures (SenseWearTM Accelerometer-based Wearable).
Wearables could thereby provide a more accurate picture of physical activity, then PROs and objective measures would not face self-reporting bias.In addition to their use in monitoring physical activity, wearables can also be utilized to track other health parameters, including sleep patterns, heart rate, and glucose levels, among others. These devices have been shown to be highly accurate in monitoring these parameters, and the data collected can be used to gain insights into the health of participants in clinical trials.
Decentralized clinical trials with wearables
Furthermore, wearables can enable decentralized clinical trials, which can be especially beneficial in situations where participants may have difficulty traveling to study sites or where in-person visits may be limited due to external factors, such as the COVID-19 pandemic. By enabling remote monitoring of participants’ health, wearables can reduce the burden on study participants and researchers and provide a more complete picture of each participant’s health.
Challenges associated with wearables in clinical trials
However, there are also challenges associated with the use of wearables in clinical trials. One major challenge is the potential for data overload. Wearables can generate a large amount of data, and it can be challenging to manage and analyze this data effectively. Additionally, there may be concerns around data privacy and security, as wearables collect sensitive health information that must be protected.
Wearables offer significant potential for improving clinical trials
Despite these challenges, wearables offer significant potential for improving the accuracy and efficiency of clinical trials. By providing real-time monitoring of participants’ health and reducing the burden on study participants and researchers, wearables can help to improve the quality and reliability of clinical trial data. As wearables continue to evolve and become more sophisticated, their use in clinical trials is likely to become increasingly common.