Decision-making in drug development: Application of a clinical utility indexSM

Abstract

The Clinical Utility IndexSM (CUISM) is a practical and useful approach for informing drug development decisions where multiple aspects of a drug's clinical profile must be optimally balanced. In its most common application, a CUI is a model of population-level preferences across and within the various efficacy, safety, and tolerability attributes of a product profile for a given indication. By combining the multiple dimensions of a product profile into a single unit of utility, the CUI can easily be linked to pharmacometric simulations of clinical endpoints, thus extending the reach of clinical trial modeling and simulations further into the decision-making process. Although the use of CUI (and related multiattribute methods) is relatively new to the field of drug development, its application is steadily growing as project teams discover the benefits of integrating "utility" models into the overall pharmacometric toolbox. © American Association of Pharmaceutical Scientists 2011.