By Joerg Gruenwald, Co-Founder, analyze & realize GmbH10.19.22
The trend of digital data gathering in the performance of clinical trials started during the COVID-19 pandemic to prevent close contact between study participant and investigator.
In traditional clinical trials, study participants travel to the study center for visits, where the study takes place in its entirety. In decentralized clinical trials (DCTs), the study “comes to the participant” with the aid of teleconference and remote data capture with devices that are often wearable.
Participant travel to the study center becomes unnecessary, with very few exceptions, which not only lessens personal contact but also has a positive effect of reducing travel miles and reducing carbon emissions.
Wearable technologies have become increasingly popular in healthcare settings in general and clinical trials in particular due to their innovation and growth over the past few years. While most devices are marketed as lifestyle gadgets that track consumers’ fitness and wellness habits, they are equipped with powerful biosensors that offer great potential for clinical trials.
Wearables can be used to monitor a range of variables, such as vital signs and physical activity. From the numbers pulled from clinicaltrials.gov, as of September 2022, more than 1,700 clinical trials with wearables were being conducted, with about 650 of them having been completed.
The functionality of these devices and the kinds of data that are fed into the database to be analyzed in these clinical studies include activity tracking, ECG, heart rate, heart rate variability, sleep, glucose monitoring, peripheral oxygen saturation (SpO2), haptics, UV tracking, and pressure sensors.
For example, wearables for monitoring blood sugar are already widely used to track glucose levels in real time throughout the day and night. A recent study also showed that the measurements of SpO2 obtained using the Apple Watch are reliable compared to the standard pulse oximetry technique in patients with cardiovascular disease.
Clinical trial models based on the integration of wearable devices and smartphones demonstrate compelling benefits. These devices gather real-world-data (RWD), which means that wearable technologies enable 24/7 data streaming and therefore continuous measurement of objective, repeatable, and quantifiable data as subjects follow their daily routines. This offers the opportunity to build richer patient health profiles.
It has been shown that, in a majority of these trials, using wearable devices improves effectiveness by lowering clinical site times and personnel requirements.
The availability of accurate measurements improves patient-reported outcomes (PRO) and delivers time-marked data to compare and verify PROs.
Wearables also help in preventive medicine by sending alerts when health conditions deteriorate.
Another obstacle to the use of wearables in clinical studies is the accuracy of measurements, as these devices are often not certified as medical devices. Therefore, not every wearable is automatically suitable and approved for medical use. Still, it is predicted that by 2025, 70% of clinical trials will incorporate wearables.
In Germany, the competent health authority BfArM has compiled a database of digital apps for wearables and smart phones that have been proven to be suitable for clinical trials.
Reimbursement is even possible if an appropriate clinical trial was able to show an advantage to using the app during an intervention.
Food business operators that need to conduct a clinical trial using the new decentralized procedures, or that wish to certify a health app with data from a clinical trial, should contact a CRO that is well-versed in these methods such as analyze & realize GmbH.
About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; jgruenwald@a-r.com.
In traditional clinical trials, study participants travel to the study center for visits, where the study takes place in its entirety. In decentralized clinical trials (DCTs), the study “comes to the participant” with the aid of teleconference and remote data capture with devices that are often wearable.
Participant travel to the study center becomes unnecessary, with very few exceptions, which not only lessens personal contact but also has a positive effect of reducing travel miles and reducing carbon emissions.
Wearable Technology Benefits
Concomitantly, as clinical research becomes ever more decentralized and trial managers interact less with participants, technologies such as wearables and remote sample collection are becoming increasingly valuable to trial completion.Wearable technologies have become increasingly popular in healthcare settings in general and clinical trials in particular due to their innovation and growth over the past few years. While most devices are marketed as lifestyle gadgets that track consumers’ fitness and wellness habits, they are equipped with powerful biosensors that offer great potential for clinical trials.
Wearables can be used to monitor a range of variables, such as vital signs and physical activity. From the numbers pulled from clinicaltrials.gov, as of September 2022, more than 1,700 clinical trials with wearables were being conducted, with about 650 of them having been completed.
The functionality of these devices and the kinds of data that are fed into the database to be analyzed in these clinical studies include activity tracking, ECG, heart rate, heart rate variability, sleep, glucose monitoring, peripheral oxygen saturation (SpO2), haptics, UV tracking, and pressure sensors.
For example, wearables for monitoring blood sugar are already widely used to track glucose levels in real time throughout the day and night. A recent study also showed that the measurements of SpO2 obtained using the Apple Watch are reliable compared to the standard pulse oximetry technique in patients with cardiovascular disease.
Clinical trial models based on the integration of wearable devices and smartphones demonstrate compelling benefits. These devices gather real-world-data (RWD), which means that wearable technologies enable 24/7 data streaming and therefore continuous measurement of objective, repeatable, and quantifiable data as subjects follow their daily routines. This offers the opportunity to build richer patient health profiles.
It has been shown that, in a majority of these trials, using wearable devices improves effectiveness by lowering clinical site times and personnel requirements.
The availability of accurate measurements improves patient-reported outcomes (PRO) and delivers time-marked data to compare and verify PROs.
Wearables also help in preventive medicine by sending alerts when health conditions deteriorate.
Data Challenges
On the other hand, using wearables in clinical trials comes with many challenges, including accessing raw data, processing and analyzing massive amounts of data, and data security.Another obstacle to the use of wearables in clinical studies is the accuracy of measurements, as these devices are often not certified as medical devices. Therefore, not every wearable is automatically suitable and approved for medical use. Still, it is predicted that by 2025, 70% of clinical trials will incorporate wearables.
In Germany, the competent health authority BfArM has compiled a database of digital apps for wearables and smart phones that have been proven to be suitable for clinical trials.
Reimbursement is even possible if an appropriate clinical trial was able to show an advantage to using the app during an intervention.
Food business operators that need to conduct a clinical trial using the new decentralized procedures, or that wish to certify a health app with data from a clinical trial, should contact a CRO that is well-versed in these methods such as analyze & realize GmbH.
About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; jgruenwald@a-r.com.