Beyond the Ten-Minute Checkup: How Digital Biomarkers are Rewriting Indian Clinical Trials
Companies conducting a clinical trial for pharmaceuticals have always relied on rare and face-to-face visits to determine whether a medication is effective. However, digital biomarkers are altering this trend.
Digital biomarkers are biological and behavioural metrics acquired using wearables and sensors, validated against clinical outcomes to a high degree that allows them to serve as a real indicator of the efficacy of a therapy. Because these metrics can be collected continuously without requiring the participant to be physically present at the clinic, digital biomarkers provide a more comprehensive understanding of the patient’s response to therapy than periodic clinical assessments. The following article investigates digital biomarkers and their use in clinical trials: what they are, the regulatory framework for digital biomarkers in India (where this technology is already being utilised), and limitations of their usage.
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