Research fundamentals: III. Elements of a research protocol for clinical trials

A clinical trial is a powerful technique for evaluating the effectiveness o f an experimental intervention. The initial stages of planning a clinical t rial involve choosing and refining a research question, selecting a study d esign, and deciding on appropriate statistical tests and sample sizes. The success of the study depends upon how well these issues are thought out in advance, and how they can be put into practice. The protocol is the written document that allows the investigator to communicate details of how the re search question will be answered. In the following article, the basic compo nents of the research protocol are described. Issues related to quality con trol, data entry, and pilot testing are discussed. This is the third in a s eries of research fundamental concept papers, written by members of the SAE M Research Committee.