Decentralized clinical trial pioneer, ObvioHealth, recently released an article discussing the prevalence of sensors, wearables, and digital biomarkers. In this article, the company talks about how digital technologies are reshaping medical research, diagnostics, and therapeutics.
The article starts by explaining the difference between the three terms. The company states that, while there are some overlaps, the three are different and it is important to understand the distinction between them.
Medical sensors, according to the article, are small devices that record data from a patient’s body in real time. These can be placed on–or even inside–the body. Sensors can be used to measure health data, such as blood pressure, blood glucose, and blood oxygenation; body temperature; cardiac data; metabolic markers, and more.
Wearable sensors, or wearables, also monitor and record patient data, but they do so through devices physically worn by the patients. The ability to put them on or take them off–i.e. wear them–is what distinguishes wearables from medical sensors, says the company.
It also notes that there are wearable sensors and consumer wearables, where consumer wearables are often not suitable for clinical research, as they lack the level of accuracy required.
A digital biomarker, the article explains, is “a characteristic or set of characteristics, collected from digital health technologies, that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.”
Biomarkers can be diagnostic biomarkers; pharmaco-dynamic/response biomarkers; or monitoring biomarkers.
Digital biomarkers can be categorized into active or passive, depending on how the wearable captures data, according to the article.
In the article, ObvioHealth also explains that biomarkers and their applications are not new. However, digital biomarkers harness the power of technology to gather and apply objective data.
Collectively, sensors, wearables, and digital biomarkers can be referred to as digital instruments, and these can be used to advance clinical research.
These instruments can be sent to patients, allowing them to measure and collect information away from the study site. This helps overcome the issue of geographical distance, explains the company.
In addition, it is also helpful for patients who suffer from chronic pain or fatigue, who might find it difficult to visit the study site. Moreover, because these digital instruments offer more precise tracking, assessments in trials will be more accurate, asserts the article.
The business clarifies that it’s important for sponsors to first determine the outcomes to be measured and then choose the digital instruments in order to maximize relevancy and accuracy of data.
Once the endpoint has been identified, the company says, sponsors need to undertake three steps in order to select the right instruments:
Technical validation: Assessing if the instrument is fit for use in the trial, based on how usable, reliable, and reproducible the technology is.
Clinical validation (or medical validation): Assessing the instrument’s value to the trial and how suitable it is to the study’s scientific parameters.
Participant validation: Assessing if the device will be tolerable and usable for trial participants.
As thought leaders in the field of decentralized clinical trials, ObvioHealth also touches upon the future of digital endpoints in this article. It discusses how artificial intelligence (AI) could be leveraged to make sense of the vast amounts of data collected by these devices.
The article also discusses the role of machine learning (ML), deep learning, computer vision, and signal processing in analyzing the vast quantities of information to get meaningful insights.
In conclusion, the company claims that these instruments will help clinical trials gather richer data and capture meaningful signals in real time.
ObvioHealth offers customers a platform and an app to help them manage decentralized clinical trials while tracking and capturing valuable data. To learn more about the company, please visit https://www.obviohealth.com/
ObvioHealth USA, Inc.
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