Principled Structured Incorporation of Clinical Knowledge Into Strategic Development Decisions

Abstract

Efficient use of limited pharmaceutical product development resources requires integrating multiple attributes, such as efficacy, safety, pharmacology, and so on, to decide at any stage whether the development of a product should proceed aggressively or slowly or be terminated. The decision process proceeds most effectively when the knowledge and experience of a product development team are transparently and reproducibly integrated with the findings from completed experiments and trials. In this article, the authors describe an approach for quantitatively and objectively assessing evidence at any stage of development, one based on a mathematical combination of sets of pairwise comparisons. The attributes of the process and the rules for combining its elements to guide decisions are determined by the project team and other stakeholders before obtaining the determinative data to facilitate exploration of the sensitivity of a recommended action to various assumptions. Its statistical properties can be evaluated with standard statistical decision analysis methods.