SCS Capabilities — Applied Modeling and Simulation Training Curriculum
Modeling and the Clinical Utility Index
(1 day course, lecture and computer-based lab)
Historically, trial designs have been concerned primarily with drug efficacy,
and therefore, modeling and simulation technologies used for clinical
trial designs have focused on efficacy. The clinical utility and economic
worth of a compound depends on many dimensions beyond efficacy, including
important influences such as target population, presence on provider
formularies, convenience, and patient compliance. To enhance market share
and value to patients, pharmaceutical companies should consider those
dimensions explicitly throughout the drug development process. The use
of a clinical utility index (CUI) can help companies consider these attributes
in a systematic manner and enhance communication between the discovery,
development, and commercial groups.
This course shows how to develop and use a clinical utility index. Topics include: axioms of utility; assessing components and levels of a utility function; understanding the impact of uncertainty; sensitivity of results to assessments; handling disagreement; the relationship to conjoint analysis; impact and avoidance of subjective biases.