Clinical trials are an integral aspect of medical research and therapy development. With an increasingly high profile, the equipment and processes used in those trials are more critical than ever, specifically digital tools enabled by wireless sensors and networks. Tools related to remote patient monitoring (RPM) can deliver high-quality data on the patients without the need for close proximity, through the use of automated and continuous data capture from medical wearable sensors.
Typically, clinical trials originate on site in a healthcare or educational facility with a dependence on subjects to then self-report required information from home. Even before COVID-19, that process had issues with continuity and trial subject compliance. In today’s healthcare landscape, social distancing guidelines and facilities with limited staffing and capacity make face-to-face interaction even more difficult which is causing a disruption in many trials.
To adapt and move forward, digital tools – specifically RPM technologies – are gaining traction as a means for efficient, accurate patient monitoring and data collection. Sensor-based digital tools can provide ongoing measurement of myriad aspects of health conditions from anywhere, which means potential subjects aren’t required to reside in a specific geographic area. This helps expand the potential scope of a clinical trial, opening it up to more participants and greater reach. But, no matter how many subjects are involved or where they’re located, one of the most critical aspects of any trial is continuous data collection. In the past, subjects were asked to take on the responsibility for measuring and reporting physiological information or symptoms while at home. With RPM, it can be automated. As an example, instead of being asked to record and then report body temperature three times a day which provides limited data points with the chance of omissions, wearable temperature sensors can automatically and continuously provide a more complete dataset with less effort by the subject.
RPM TECHNOLOGIES MAKE CONTINUOMICS POSSIBLE
Continuomics, as commonly defined by the industry, is the continuous capture and application of physiological data on an ongoing basis. The idea is that more data can dramatically improve drug development for safety and efficacy.
Prior to RPM, this was not feasible – both in terms of technology and usability. On the technical side, the convergence of available and affordable sensors, networks, and cloud access was paramount in order to continuously and reliably capture patient data from remote locations. A common problem with continuous data capture in RPM situations is intermittent network disconnections, whether it be bluetooth, WiFi, or the internet. Thus, the type of RPM solution selected is very important for ensuring data integrity throughout the entire data path.
One example of this solution is VivaLNK’s Vitals Data Service, which includes sensors, mobile edge technologies, and the cloud. The sensors contain onboard memory to cache continuous data even in the event of a bluetooth disruption. The mobile edge technology synchronizes cached data from the sensors, and ensures reliable delivery to the cloud as well as cache data on the mobile device in the event of internet disconnections for later transmission.
Patient compliance is the other hindrance to capturing continuous data in remote environments. If the patient doesn’t use it, there is no data to be captured. Hence the design of wearable sensors is critical to ensuring as simple and comfortable of a process as possible for patients.
MEDICAL GRADE SENSORS PROVIDE TOP QUALITY DATA
Capturing quantities of information is only viable if the data is useful. Ensuring quality requires the use of medical-grade sensors. Food and Drug Administration (FDA) clearance is a baseline, but there are multiple levels depending on the applications. A medical-grade sensor can be cleared and validated against a baseline, but that doesn’t mean it’s the best product for a specific application. To illustrate, there are FDA cleared ECG patches which also provide derived body temperatures. These approaches to capturing temperature tend to be highly susceptible to ambient changes and must be calibrated daily, and thus aren’t feasible in ambulatory or RPM situations. Furthermore, these types of temperature patches may not be considered a clinical thermometer nor meet the ASTM standard for an electronic thermometer even though it is FDA cleared. The VivaLNK axillary temperature sensor is both an FDA cleared clinical thermometer and meets the ASTM E1112 standard, equivalent to a mercury thermometer in the same location.
RPM POWERING CLINICAL TRIALS
In a 10 year, 3,000 patient longitudinal study by UCSF designed to detect biomarkers of early atrial transformation in atrial fibrillation (AF), subjects used VivaLNK wearable ECG monitors to continuously capture data. Monitoring included ECG recording for rhythm, heart rate and RR-interval with the goal of determining incident AF as well as progression and recurrence of AF. Participants were expected to wear the ECG monitor for one week at a time each month, on an ongoing basis. Data captured from the study is retrospectively analyzed using an ECG software to help identify possible digital biomarkers of development and progression of AF. And due to the length of the study, it was also critical that the wearable monitor was easy to use by the subject while at home.
Stanford University conducted a study on stress and teenage depression which also made use of VivaLNK RPM technologies. This study sought to find a correlation between physiological stress and activities, and how they relate to depression. The VivaLNK wearable ECG monitor allowed for ongoing monitoring of stress, recovery, activity, and sleep levels by collecting continuous data such as heart rate variability and motion. With the ability to collect physiological information outside of the laboratory, clinicians could delve into physiological dynamics throughout the day and correlate that with events and situations within the subject’s day-to-day life. This 24-hour monitoring allowed researchers to continuously collect data, including time of day, which provided benefits to researchers. For example, this constant data loop helped them understand whether a stress event is isolated or recurring. In addition, this rich information allowed them to further evaluate and contextualize these events to other variables, including particular time periods within a day or week, amount of sleep, screen time, and social circumstances.
Studies like these are made possible in a COVID-19 world through the use of evolving digital tools including RPM technologies that are more efficient and effective than previous options. Participants can easily use the RPM devices, thereby providing those conducting the clinical trials with access to a greater pool of participants without the restrictions of geography or in-person attendance. Medical grade devices then ensure a continual stream of quality data that ultimately results in better outcomes. Accuracy, efficiency and effectiveness combine for higher quality and quantity of information for a broad range of clinical trials.
RPM technologies not only power the world of clinical trials, but can also change the landscape of delivery healthcare around the world.
Jiang Li, founder and CEO, has both passion and extensive experience in bringing innovative technology and products into the marketplace. Li’s nearly 20-year career in high technology took a new direction when a routine health check landed him at the ER under examination out of fear he was in the middle of a heart attack. Noticing the outdated monitoring technologies in the hospital, he knew emerging technologies could be properly implemented and sought to apply his background in flexible electronics to healthcare. Prior to joining VivaLNK, he was responsible for new product and technology development as the VP of engineering in Kovio and Thinfilm Electronics, leading printed electronics companies. Prior to that, he worked at AMD and the joint venture between AMD/Fujitsu, Spansion. As the VP of product engineering in Spansion, Jiang managed the major new product launches in Spansion. Jiang holds a Ph.D. degree from the University of Wisconsin-Madison and a bachelor’s degree from Zhejiang University in China.