Preclinical and Early Clinical Development of Chemotherapeutic Drugs, Mechanism‐Based Agents and Biologics

Abstract

Overview Over the past 10 years, the approach to drug development has changed considerably. Owing to the enormous increase in insights into the molecular biology of cancer cells, a largely empirical approach has been mostly abandoned and replaced with a biology‐driven, hypothesis‐based, and translational approach. Notwithstanding this dramatic development, the hierarchical sequence of clinical drug‐development trials basically remained unchanged and is divided into three phases. This chapter provides an overview of the various steps of early clinical development with milestones of the drug‐development process, the role of the National Cancer Institute, and the switch to mechanism‐based drug development. It outlines challenges in the clinical development of these new agents and provides a fundamental understanding of the complexity involved in early clinical drug development.