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Clinical Utility Index (CUI) Analysis
Traditionally, trial designs have been concerned with drug efficacy. As a result, modeling and simulation technologies used for those designs have also focused on efficacy. However, the clinical utility and economic worth of a compound depend on many dimensions beyond efficacy, including target population, product formulation, third-party payer acceptance, and patient adherence.
A CUI provides a single metric for multiple dimensions of benefit and risk, and captures expert opinion on the clinical and commercial importance of various product characteristics. A CUI also helps your organization understand and explain the difference in clinical daily doses among Europe, the United States, Japan, and other regions. Finally, a CUI enhances communication between discovery, development, regulatory affairs and marketing functions. A CUI can be used to determine appropriate dosing, as an objective in clinical trial design, and as a first-order valuation tool for in-licensing candidates.
Benefits of using a CUI include enhanced collaboration, increased confidence in decisions, and stronger commercial results.