Well-Defined Study Objectives and Endpoints

All of the studies that are performed before a therapeutic confirmatory trial is started collect information that facilitates a logical scientific progression from human pharmacology studies to the point where conduct of a therapeutic confirmatory trial is appropriate. In a real sense, all of these smdies, and all of the information gained to date, have had one purpose to allow the primary objective in the therapeutic confirmatory trial to be stated as simply as possible. In this context, the word simple is not pejorative. To the contrary, a primary objective that can be stated simply can be tested simply, i.e., in a straightforward and unambiguous manner. This is a highly desirable attribute in a primary objective. 

The previous section discussed the concerns that accompany multiple comparisons, i.e., the issue of multiplicity. In the context of study objectives, the greater the number of objectives presented in a study protocol, the greater the number of comparisons that will be made at the analysis stage, and the greater the chance of a type I error. As Machin and Campbell (2005) commented, If there are too many end- 

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