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

With the recent evolution of regulations governing investigational diagnostics, it has become vitally important for diagnostics developers to understand how to design and conduct trials that demonstrate the clinical utility of their tests to healthcare payers, regulators, and physicians.

By weighing certain factors that impact the use of a molecular diagnostics device, developers can increase the likelihood of successfully demonstrating clinical utility. For example, finding ways to reduce variability in physician decision-making or increase patient adherence with recommended treatments can help you save time and cost. Lay the foundation for demonstrating clinical utility by identifying:

• The diagnostic’s intended use, proposed indication, and target patient population
• The clinical decisions that are expected to result in improved health outcomes
• The physicians who make relevant treatment decisions and the context in which they make them
• Evidence for linkage between such treatment decisions and clinical outcomes
• Any accepted surrogate endpoints for the desired clinical outcome

While these considerations can better inform an RCT, explore five ways to approach how an RCT should be designed and conducted to fully achieve clinical utility.