The next edge in drug development will come from understanding patients at higher resolution.
For decades, clinical evidence was shaped by scheduled visits. What patients reported. What clinicians observed. Everything between visits remained largely unseen.
The FDA’s Digital Health Technologies program is expanding the use of continuous and frequent measurements beyond traditional study visits, including through wearables, sensors, and remote monitoring.
For drug development, this opens the possibility of following treatment response beyond scheduled assessments and across the patient journey.
But capturing these signals is only part of the challenge.
Biological signals, interventions, and outcomes remain fragmented across the patient journey. Without coordination, the longitudinal picture remains incomplete.
The next infrastructure layer will need to connect these signals with interventions and outcomes across time, institutions, and real-world conditions.
As the FDA advances the regulatory pathway for digitally derived endpoints, that coordination layer becomes increasingly important to drug development.
Source: FDA, Digital Health Technologies for Drug Development
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