Incorporating clinical knowledge and experience in the evaluation of drug development projects using the analytic hierarchy process

Abstract

Resource limitations require balancing factors such as efficacy, safety, market urgency, etc. to reach objective and consistent decisions at the various stages of drug development. Decisions about pursuing, delaying, or terminating a potential drug depend on the knowledge and experience of the product development team and the findings from completed experiments and trials. We describe how the analytic hierarchy process can be used to inform decisions, and illustrate its application to an actual development project. The dimensions of the decisions, the rankings of the possible outcomes for each dimension, and the rules for combining the components are determined by the key stakeholders before obtaining the determinative data. Laying out the rules before a product reaches a decision point facilitates exploration of the sensitivity of potential decisions to various assumptions. The process can be applied at any stage of clinical development. Its statistical properties can be evaluated using standard statistical decision analysis methods.