Recommendations concerning Studies on Therapeutic Equivalence

This paper provides recommendations when the requirement to demonstrate the superiority of a new therapeutic regimen compared to placebo or to an accepted standard therapy before bringing it into practice is abandoned. In this situation a study can only aim at demonstrating therapeutic equivalence of different treatments. This procedure is justified if in addition to therapeutic equivalence in a main outcome variable, other advantages of the new therapy can be expressed. In general, more detailed information must be available for the justification of an equivalence trial compared to the common investigations planned to show the superiority of a new therapy. This also concerns the adequate interpretation of the results.