ABSTRACT
This chapter focuses on the essential considerations of project management as it relates to efforts of designing innovative clinical trials. Process-driven methodology requires a particular set of steps in a particular order without exception, whereas principle-driven methodology instead focuses on the overarching goal or outcome achieved. This important distinction is especially valuable in situations where processes are too prescriptive and restrictive and/or become outdated quickly as the industry and work rapidly evolves. As one can imagine, principle-driven methodology makes for a compelling case in the design of innovative clinical trials given that what is innovative today may soon become standard practice and new innovations will emerge. This approach also allows for the Project Manager and other key personnel to select from a range of practical steps that can reflect differences among projects such as industry/entity type, timelines, regulatory bodies providing oversight, and scopes and budgets of all sizes.
