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An expert-led analysis on the trends and opportunities of leveraging digital measures in pharmaceutical R&D.

The Value of Digital Measures in Drug Development Pharmaceutical companies have not fully utilized the potential of digital measures in clinical trials due to their high cost and lack of standardized applications across therapeutic areas. However, experts recognize the potential benefits of digital measures in accelerating drug development and enhancing our understanding of treatment efficacy. Experts predict a shift towards using digital measures as primary endpoints and supporting label claims in the future. Experts further estimate that digital endpoints will support label claims within the next 3-5 years.

The Importance Digital Measurement Strategies in Pharma Transitioning digital measures from controlled clinical trials to real-world settings requires careful consideration and compliance. Pharmaceutical companies must define digital measurement strategies that focus on the entire lifecycle of an endpoint, select measures with the greatest utility, and bridge the gap between the endpoint or biomarker and clinical need. A strategic 'toolbox' approach to using digital measures is needed to deploy them purposefully across different therapeutic areas and settings.

Payer acceptance will be crucial in driving the use of digital endpoints forward, especially in the commercial realm.

The Imperative for Pre-Competitive Collaboration The success of digital endpoints, including digital biomarkers, depends on open-source collaboration and scalability of digital measures. Experts contend that this will require pre-competitive collaboration on the development of truly patient-centric metrics that are decoupled from pharmacologics. Given that pharma companies are building compounds on the same science, they should apply this principle to digital endpoints, including digital biomarkers. The industry's pursuit of optimized drug development should incentivize digital measures in both clinical trials and real-world applications. To expand the use of digital measures in clinical development, stakeholders need to work together through industry consortiums, regulatory standardization, and sharing of validation data. It is time for pharma companies to prioritize collective action to usher in a new era of medicine.

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