JANUARY 20259TECH OUTLOOKDigital biomarkers used in pivotal clinical trials as primary endpoints need to undergo verification, analytical validation, and clinical validation before seeking acceptance from regulatory authoritiesmeaningful 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. wearable devices can electronically acquire data on patients' biological responses. Continuous glucose monitors are also well-established as passive measurement devices through wearables. However, there are still technical hurdles to overcome for active measurement using digital biomarker, such as cognitive assessment.Biomarkers are particularly compatible with central nervous system (CNS) disorders, including psychiatric and neurological diseases, where subjective clinical assessments are often relied upon for diagnosis. The development of digital biomarkers aided by AI algorisms could be a breakthrough in this area. Among the various biological responses that can be measured, the digital voice biomarker shows promise as a continuous, non-invasive disease monitoring tool that can be also utilized in screening and diagnosis of a broad range of conditions, not only CNS diseases but cardiovascular and respiratory diseases.The use of digital biomarkers in clinical trials offers several advantages. They can accurately measure clinically meaningful aspects of 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
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