Rewriting The Rules Of Clinical Trials Through Digital Biomarkers

Digital biomarkers are rapidly redefining how clinical trials are designed, executed, and evaluated. By moving beyond episodic clinic visits and capturing continuous, real‑world data, these tools offer a deeper, more responsive view of patient health. Subtle physiological or behavioral changes — such as shifts in mobility, sleep patterns, or heart rate variability—can now be detected earlier, allowing development teams to assess therapeutic impact with greater precision. This shift has the potential to streamline timelines, reduce patient burden, and curb escalating development costs.

Yet meaningful adoption requires overcoming hurdles around data privacy, interoperability, regulatory acceptance, and rigorous validation. Cross‑industry collaboration is emerging as a critical enabler, and forums like the Clinical Trials Technology Congress (CCTC) are accelerating this progress. A dedicated Digital Biomarkers Workstream will highlight how sensor technology, AI, digital endpoints, and patient‑centric tools are moving from promising concepts to applied clinical strategies.

For clinical operations, digital innovation, and R&D teams, this preview offers a window into where the field is heading — and why now is the moment to engage. Access the full article to explore the insights and opportunities shaping the next generation of clinical trials.