Assignment task:
Rephrase. FDA regulations have recognized since 1985 the critical need to know, for an NI trial to be interpretable, that the active control had its expected effect in the trial. Thus, 21 CFR 314.126(a)(2)(iv), unchanged since 1985, says: If the intent of the trial is to show similarity of the test and control drugs, the report of the study should assess the ability of the study to have detected a difference between treatments. Similarity of test drug and active control can mean either that both drugs were effective or that neither was effective. The analysis of the study should explain why the 3 drugs should be considered effective in the study, for example, by reference to results in previous placebo-controlled studies of the active control drug.