Designing clinical research studies: Part I

Research study design requires careful planning and key decisions. While these steps may seem tedious, they will save time and perhaps aggravation later. In addition, if you plan to seek funding for the study, you must provide a detailed description of how you plan to conduct it. Part 2 of study design (December 2003) will include how to determine the number of subjects, how to select measures for the variables, and what should be included in the procedures and the plan for data analysis sections.