Good clinical practice and the conduct of clinical studies in pediatric oncology

This article discusses the principles that guide good clinical practice standards, with particular emphasis on how they to relate to pediatric oncology research and recent efforts at harmonization. The authors review the clinical trials process and the roles of the participants, highlighting the pivotal role of the clinical investigator and the research team, and briefly review the historical aspects of drug development regulations in the United States and the current regulatory paths for pediatric oncology drug development. Where relevant, historical events that underlie many of the regulations and their current applications are described, and practical examples are provided.