Teaching the principles of clinical trials design and management

This paper presents the aims, conduct and references that we feel would be appropriate for a formal interdisciplinary graduate course in the design and management of clinical trails. Recent papers in the medical and statistical literature, accompanied by in-class discussion, constitute a good "text". Opportunity to gain "experience" can be provided by assignments to review and critique clinical trials reported in the literature, and especially by an assignment to design "from scratch" a clinical trial. Practice in interdisciplinary discussions and decision-making is afforded when biostatistics students and other research-oriented students take the course together.