Upcoming Session: The DIA Statistics and Data Science Community is pleased to announce a new shared learning presentation being held on 24th June 2025 at 11am CST. Registration is now OPEN for this FREE webinar:
There’s growing interest in digital biomarkers (from vital signs to lab value trajectories) as tools to better understand patient physiology in both clinical care and research. Unlike traditional endpoints, digital biomarkers offer continuous rather than intermittent data, more objective assessments than patient-reported outcomes, and the potential for personalized insights from repeated measures over time.
While formal validation is essential for regulatory submission, many organizations can gain tremendous value from custom-made biomarkers used for internal decision-making, exploratory analyses, or early signal detection. The good news? You don’t need a full clinical validation pipeline to start building them.
In this session, we’ll take a Build-a-Bear approach to constructing digital biomarkers: outlining the key components, design decisions, and practical tips for translating raw vital sign or lab data into meaningful, internal-use metrics. Whether you're working with wearable data, EHR vitals, or clinical trial lab values, you'll walk away with a clearer sense of how to design and prototype your own fit-for-purpose digital biomarkers tailored to your organization’s needs. Checklists included!