What type of study is this?

This is a Literature Review study.

What question did this study set out to answer?

The aim is to address the challenges and potential of digital biomarkers in healthcare and clinical trials.

February 23, 2026Communications MedicineOpen Access

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Perspective explores continuous monitoring and personalized medicine via digital biomarkers, highlighting regulatory reviews' challenges.

The aim is to address the challenges and potential of digital biomarkers in healthcare and clinical trials.
Review of real-world use cases of digital biomarkers
Identification of challenges in evidence generation and regulatory reviews
Discussion of potential pathways for integrating biomarkers into clinical practice
Digital biomarkers enable continuous monitoring and personalized medicine
Issues like costly evidence generation and regulatory hurdles hinder clinical use
Proposed solutions include harmonized qualification pathways and adaptive evidence loops

Lieberwirth et al. (2026) studied this question.

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