Design and analysis of oncology clinical trials

Abstract

In this chapter, we discuss the design and analysis of oncology clinical trials. Because analysis follows naturally from design and is specified a priori in any well-planned trial, it is appropriate to discuss these topics together. We review clinical trial designs and associated analytical methods used in the different phases of therapy development. Along the way we identify areas in which the methodology is adapting to new approaches to therapeutic intervention. This chapter provides only a brief sketch of the main concepts and current research areas, and we refer the reader to primary sources and comprehensive texts on clinical trials in oncology for further details. Two excellent recent texts in particular, the Handbook of Statistics in Clinical Oncology and Clinical Trials in Oncology, provide the fundamentals of trial design, conduct, and analysis, as well as up-to-date discussion of new challenges and active research in statistical methods for oncology clinical trials. © 2006 Springer Science+Business Media, Inc.