Recently, researchers from Israeli have utilised wearable sensors for collecting vital data on those undergoing vaccine trials. Why is data so important during vaccine trials, what did the researchers develop, and how does this demonstrate the importance of wearable technology?
Medical trials have been crucial in the field of medicine ever since the development of the first treatments. Trials allow for medicines to be tested on all kinds of individuals to ensure that the treatment performs as expected with minimal side effects while also ensuring that medical experimentation is done on willing individuals. Medical trials often come with a great deal of risk and thus pay very well.
But it has only been in the past two years that the importance of vaccine trials has truly come to light. The COVID pandemic of 2020 demonstrated just how vulnerable the world is to new strains of contagious pathogens, pushing researchers to refine vaccine development technologies. But no amount of vaccine development will get people vaccinated if the vaccine cannot be proven safe, which is why vaccine trials are so important.
When conducting a vaccine trial, the environment of each patient must be carefully controlled to minimise the number of factors that may affect the vaccine. It is also essential to get as much data from each patient as possible so that researchers can understand precisely how the vaccine has affected an individual.
Vital data to a vaccine trial can include heart rate, breathing rate, temperature, skin hydration, bowel movements, and any symptoms a test subject may have. Having enough staff to record this data can be challenging, and trying to attach test subjects to sensors 24/7 for multiple weeks is impractical. And yet, having access to real-time changes could provide researchers with valuable insights such as the best time to take the vaccine, how it interacts with bodily functions, and improving efficacy.
Recently, researchers from Israeli utilised a wearable smart sensor for use with vaccine trials to provide real-time data on test subjects. The sensor used was an FDA-approved chest-patch sensor that wirelessly connects to a mobile app that provides 13 different simultaneously readings, including heart rate, blood oxygen, stroke volume, skin temperature, and pressure. Furthermore, the mobile app developed by the researchers asked test subjects questions about their perceived status (i.e., symptoms).
The trial, which involved 160 participants, was conducted on the BNT162b2 COVID-19 vaccine to test the use of sensors and compare the gathered data to what test subjects were self-reporting. To the researcher's surprise, there was often a large discrepancy between perceived symptoms and actual data. In particular, the researchers noted that asymptomatic patients had notable changes in their data, especially during the night.
It goes without saying that data in a vaccine trial is important, but trying to connect test subjects to monitoring devices continuously can cause great discomfort. Furthermore, test subjects will be required to move around and not be sat on a bed or chair for too long as this can lead to clots in the form of DVT (therefore, hospitals will often give anticlotting medication to patients in bed).
Thus, attaching sensors to test subjects who can then go about their daily activities can provide real-time data that is invaluable to vaccine trials. In the case of the Israeli researchers, the ability to get data when test subjects are asleep could even show changes in their biology that were not apparent to the test subjects or the researchers.
Without such sensors, the researchers may have never seen the effects of the vaccine on subjects at night, nor would they have seen discrepancies between recorded data and self-perceived symptoms. The ability to get data in real-time with wearable sensors also raises the potential for researchers to use fewer participants in future trials, which could significantly speed up the delivery of vaccines should a new strain develop.