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The success of a clinical trial rests on achieving clinical and statistical significance on the primary end point of the study. Therefore, proper selection of primary and key secondary end points is of the utmost importance for obtaining regulatory approval of a drug, as well as for identifying the proper therapeutic profile of the agent. If there is an inappropriate selection of study end points, an efficacious drug could appear as nonefficacious or the specifics related to a drug’s profile may not be correctly described.
