ABSTRACT
A Clinical Development Plan (CDP) is a detailed plan that lays out the path for obtaining regulatory approval of a single indication. It typically contains a commercial rationale, a scientific rationale, an investigational plan (including the target product profile, roadmap of trials, study design schemas, and statistical assumptions), a regulatory plan, and a governance summary that captures the operating assumptions for the investment opportunity. This chapter describes the utility of the CDP, its contents, and a process that project managers can follow to create a CDP. We also discuss the risk assessment in the form of probability of technical and regulatory success.
