How to Design a Clinical Trial

Clinical research, like all research, stems from curiosity. Although some research questions are harder to answer than others, the application of a well-designed trial coupled with the right question can yield valuable information. Indeed, a poorly designed randomized trial will not generate as much scientific information as a well-designed and well-executed prospective observational study. The success and applicability of a research trial depends on many factors. This chapter is not intended to be a treatise on clinical epidemiology or statistics, but instead will focus on some of these factors and other practical aspects of trial design specifically related to nephrology.