In this article we discuss the adaptation of the Digital Medicine Society's (DiMe) V3 Framework, originally designed for clinical settings to preclinical research involving animal models. This adapted framework emphasizes three key components:
- Verification: Ensuring that digital technologies accurately capture and store raw data.
- Analytical Validation: Assessing the precision and accuracy of algorithms that convert raw data into meaningful biological metrics.
- Clinical Validation: Confirming that these digital measures accurately reflect relevant biological or functional states in animal models.
By implementing this structured approach, stakeholders including researchers, technology developers, and regulators can enhance the reliability and applicability of digital measures in preclinical research, ultimately supporting more robust and translatable drug discovery and development processes
