The Role of Clinical-Translational Studies in Validation of Diagnostic Devices
The Role of Clinical-Translational Studies in the Validation of Diagnostic Devices Clinical-translational studies represent the critical inflection point where a diagnostic technology transitions from a laboratory assay to a validated clinical asset. Understanding the distinction between translational research and formal clinical investigations, and how they sequence together, is essential for designing an efficient regulatory and statistical strategy. Navigating the Diagnostic…