How To Establish Clinical Utility Of Molecular Diagnostics For Precision Medicine: 5 Tips On RCT Design

By Charles Chrisawn

Healthcare payers, regulators, and physicians focus on clinical utility when evaluating molecular diagnostics tests. Clinical validation — establishing that the test can make a diagnosis or predict clinical outcomes — may not be enough to garner acceptance. This point is crucial, because failure to gain acceptance deprives patients of much-needed health benefits and results in business failure for the developer. As a developer, to ensure adoption of a novel, precision medicine-enabling diagnostic test, you must demonstrate clinical utility — a process that can be challenging.

This blog series covers ways to approach designing and conducting a randomized clinical trial (RCT) to demonstrate clinical utility.