|
Abstract:
|
With the advance of molecular biology, there have been an increasing number of targeted therapies in development. These drug candidates are often projected to be effective in a specific targeted population, defined by biomarkers. However, it is not uncommon for a targeted therapy to be effective, possibly to a lesser extent, in a more general all-comers population. Whether to develop such a drug candidate in a targeted population only or in a more general population poses a dilemma for drug developers when setting strategies for the development program. We propose a modeling approach to evaluate different late-stage development strategies from a decision analytic perspective based on a benefit cost evaluation so that optimal strategies can be derived.
|
