Guidelines for planning clinical trials.

This paper outlines the necessary steps involved in setting up and administering a clinical trial. The importance of adequate preparation, with careful definition of priorities and objectives, is emphasized. Guidelines for writing a clinical protocol are discussed in detail, as well as aids to deal with the running of the study, statistical planning, and presentation of results. The principle of different types of study, methods of patient assessment, and an overall plan of study, have already been introduced in the preceding paper.