The clinical development of antibacterial drugs: A guide for the discovery scientist

Abstract

Every decision a drug discovery scientist makes along the way will impact the ultimate product to emerge from the long and arduous discovery and development process. To meet this challenge, an innovator must have a basic understanding of those steps in this process that demand far more than knowledge of basic bench science. Perhaps the most difficult of these steps involves an understanding of regulatory and clinical development issues that only become relevant years after the potential product has overcome its initial scientific hurdles. This chapter provides a review of currently available clinical development paradigms for antibacterial drugs including non-inferiority trials and various approaches to superiority trials. The thorny problem of how pathogen-specific antibiotics can be developed is explored. The goal of this chapter is simply to familiarize the bench scientist with the challenges ahead for any project and to provide a framework for assessing risk in that context.