Just a few decades ago, we relied on wristwatches to tell us the time. Today, a quick flick of the wrist can tell us so much more: our pulse, activity levels, sleep patterns; even our blood oxygen levels.
Digital Health Technologies (DHTs) such as smartwatches and other sensor technologies like fitness trackers, eyeglasses, shoe insoles, and other familiar objects we all carry or wear, are now more prevalent in society, transforming how people track and manage their own health data. And with the increase in the reliability and accessibility of DHTs, the healthcare industry is working to incorporate these technologies and revolutionize and resulting digital biomarkers into clinical studies.
Unlike conventional endpoints, digital biomarkers measure physiological functions through noninvasive wearable sensors or digital health technologies. These sensors can provide objective and quantitative measurements of the pharmacologic effects of an investigational product, allowing us to better interpret patients’ treatment responses and physiological processes.
Digital Biomarkers can also mean a more timely and accurate collection of clinical trial data often in real-time, real-world settings. Beyond that, digital biomarkers also provide opportunities to enhance the patient experience, potentially reducing the time patients need to visit the clinic.
While this influx of DHTs creates new and exciting opportunities for researchers, there are also challenges and considerations when working to successfully develop a scalable digital biomarkers framework. The entire approach – from experimental design, operations, data collection, and analysis – is vastly different than traditional in-clinic assessment resulting in the need to define procedures, roles, and the expertise required to properly draw inferences between the measurement and the observed biological or lifestyle construct of interest.
ABOUT THE EVENT
The Digital Biomarker Summit USA will convene industry thought leaders who will share work currently underway with DHTs and digital biomarkers with the goal to propel the industry forward through education and collaboration.
The one-day, invite-only event on May 10, 2023 will showcase examples across a variety of domains, including motor function/mobility, cognitive function, sensory function, and physiological measurement. Additionally, the Summit will demonstrate how design thinking methodologies play a key role in developing digital biomarkers and discuss regulatory guidance and frameworks to help the development and implementation of novel digital endpoints within clinical trials.