Quantitative Decision Criteria

MBDD activities should begin with defining target values and criteria for decision making. These criteria should be stated as explicitly as possible and discussed by governance committees responsible for making drug development decisions. Target values and criteria may be based on a marketing target profile, an assessment of what is clinically relevant perhaps based on information provided by key opinion leaders, information on a competitor's drug – possibly through a meta-analysis, or registration criteria for drug approval, to a name a few. Understanding the key drug development questions to be addressed such that these may be evaluated quantitatively and the criteria used to make decisions, is critical to determining the type of data to be collected and models to be developed for a successful MBDD implementation.