The symposium will cover selected topics in the design, interim monitoring, and analysis of clinical trials of pediatric patients. A review of new phase I designs will be presented. These designs utilize information that emerges during the study to inform the dose escalation process. The design and analysis of comparative trials will also be discussed, with particular reference to topics relevant to trials involving children. These will include deciding on appropriate study size, issues of reduction-intherapy studies, and pitfalls in study analysis. Independent data safety and monitoring committees (DSMC) play an increasingly important role in the conduct of trials. The types of analytic tools and decision processes that DSMCs bring to the clinical trials enterprise will be discussed.