MEDICAL DEVICES
of wound healing, but the dynamic changes continually assessed throughout the procedure via the Profusa biosensor were. The exciting result of this research is that being
able to continuously monitor biochemical data, such as tissue oxygen, on a real-time basis may mean the difference between effective interventions and a catastrophic worsening of the condition. This is especially enlightening as the Profusa sensor is the first platform that can potentially collect these clinical-grade data away from the clinic and in the comfort of a patient’s home.
Acknowledging our challenges While biosensors like Profusa’s offer numerous advantages for clinical trial design and execution, they also present challenges we need to overcome. When employing biosensors in clinical trials,
we will have to train subjects on how to use them. While the biosensors themselves require no management by the wearers, the subjects or their caregivers will need to read the signals by placing the patch next to the area of the skin where the sensor is located. In carefully designed studies, where the consistency of data acquisition is important, the variability in which the subjects self- administers data collection devices may introduce unwanted artefacts to the study results. Adverse event management is another critical issue. One of the benefits of having the subjects
70 | Outsourcing in Clinical Trials Handbook
come into the clinic for regular measurements is it is a built-in checkpoint for healthcare professionals to look for adverse events. When those studies are done remotely, the study loses the opportunity to carefully monitor the subject. That may or may not be problematic depending on the study, but it is something we must keep in mind. Finally, the complexity of the data can be exponentially greater in continuous, remote monitoring. For example, in a conventional study, we might have 1,000 patients visiting the testing site four times, yielding 4,000 data points. Conversely, in a remote monitoring study, we might gather data every five seconds over a 30- day period. That becomes a much more daunting data analytics task and creates data complexities that may convolute a study result.
A bright future Despite these challenges, we believe the case for using biosensors in clinical trials is very compelling. Profusa’s biosensors will transmit clinical-
grade data at an individualised, biochemical level, facilitating more and better research – and the scientific progress that it makes possible. The technical advantages are clear, but the primary benefit will be to the patients whose lives will be transformed with new medications or devices. Our work is always, at heart, about them. ●
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