Diagnostic trials are typically conducted in several phases: - Phase 0: These are exploratory studies involving very limited human exposure to the diagnostic tool, aiming to understand how it works. - Phase I: These trials test the new diagnostic method on a small group of participants to evaluate its safety and identify side effects. - Phase II: These involve a larger group and aim to determine the diagnostic tool's effectiveness and further evaluate its safety. - Phase III: Large-scale trials that compare the new diagnostic tool to the current standard methods to determine its overall efficacy. - Phase IV: Post-marketing studies that monitor the diagnostic tool's performance in the general population.
