Teaching Courses in Clinical Trial Research Methods

This article describes nine separate elements that are part of any course: 1) the teachers, 2) the students, 3) expectations and attitudes of the teachers, 4) expectations and attitudes of the students, 5) a strategy of how to achieve the expectations, 6) materials to use, 7) types of presentations, 8) organizing the individual sessions, and 9) time and place for the course and each of its sessions. The relationship of each of these elements to a course on clinical-trial research methods is discussed. Approaches to use for designing an overall curriculum for a school, company, or regulatory authority also are discussed. Sixteen separate courses are identified and briefly described. Several methods to enhance the effectiveness of individual lectures or discussions are mentioned. Potential courses, as well as those currently offered, should be periodically evaluated by all institutions that are involved in the area of clinical-trial research methods.