Design of clinical development programs

Clinical development is the scientific process of exploring and confirming the product attributes and therapeutic role of potential new medical treatments. This chapter provides an overview of the clinical development of a pharmaceutical product for medical use, introducing and discussing the principles of clinical development and application of those principles on both a programmatic and a study level. While the development process is continuous, beginning during the discovery of an innovative potential pharmaceutical product and ending with the replacement of the innovative pharmaceutical by a more effective or safer alternative treatment, the process follows an orderly path of evidence-based, goal-directed development. This chapter focuses on the clinical development and registration of an innovative pharmaceutical product in the treatment of patients or of an additional indication for an existing pharmaceutical product.