FEBRUARY 2024LIFE SCIENCES REVIEW 19Digital biomarkers used in pivotal clinical trials as primary endpoints need to undergo verification, analytical validation, and clinical validation before seeking acceptance from regulatory authoritiesof patient health outcome, predict disease progression or treatment responsiveness to stratify participants, and address unmet measurement needs that are not currently assessed in standard clinical trials. However, there are challenges to overcome. Digital biomarkers used in pivotal clinical trials as primary endpoints need to undergo verification, analytical validation, and clinical validation before seeking acceptance from regulatory authorities. Usability assessment is also crucial to establish the tolerability and acceptability of the technology by participants.The productivity in drug development has not been high enough, with the overall probability of success of drug development at 9.6 percent, and even lower for psychiatric or neurological disorders. Developing novel digital biomarkers can offer real-time and more sensitive indicators of efficacy and safety that are clinically meaningful to patient outcomes. This may lead to earlier determination of a therapeutic product's potential assessed with a smaller sample size in pilot trials and smarter go/no-go decisions. In later stages of development, these indicators can be allowed as primary or secondary clinical endpoints with better patient engagement in supporting labeling claims.To drive the development of digital biomarkers, pharmaceutical companies, tech companies, academia, and the health care industry need to collaborate. These partnerships can lead to the investment in new technologies and the development of digital biomarkers that capture unmet measurement needs in a wide range of diseases. In the context of future drug development, digital biomarkers can play critical roles in the successful launch of a product, particularly in the field of CNS diseases, where they are envisioned as a coming revolution.
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