## What is/are Equivalence Trials?

Equivalence Trials - Of the 49 ACTs included, there were 13 superiority, eight non‐inferiority and seven equivalence trials.^{[1]}Guidance has been published in the reporting non-inferiority and equivalence trials (Piaggio et al.

^{[2]}Such studies are called noninferiority trials, which we describe in this paper in relation to superiority trials and equivalence trials.

^{[3]}Despite differences were observed, uncertainty remains on the clinical relevance of these data as by golden standard it should still be confirmed by bioequivalence trials.

^{[4]}Efficacy trials should usually be designed as equivalence trials to ensure that the efficacy of the biosimilar is neither decreased nor increased compared with the reference product.

^{[5]}The primary statistical analysis will be per protocol rather than intention-to-treat analysis because the latter increases type I error in non-inferiority or equivalence trials.

^{[6]}We propose the application of an equivalence trials framework to clarify the concept of reproducibility by changing the (narrow) equivalence zone around a zero difference by a zone of reproducibility around (a) previous finding(s).

^{[7]}Three out of the four participants with delayed emergence in Condition MixB initially failed in symmetry trials, the other two in Condition PTB failed exclusively in equivalence trials.

^{[8]}Tang derived the exact power formulas for t tests and analysis of covariance (ANCOVA) in superiority, noninferiority (NI), and equivalence trials.

^{[9]}3% favoured equivalence trials and 15.

^{[10]}bioequivalence trials, Schuirmann in J Pharmacokinet Pharmacodyn 15(6):657–680, 1987) would be appropriate instead.

^{[11]}Further research is required on comparisons of psychodynamic therapy to other treatments (equivalence trials), the treatment of specific mental disorders such as obsessive-compulsive disorder or posttraumatic stress disorder, and mechanisms of change, as well as on the effects specific to psychodynamic therapy (added value), transdiagnostic and unified protocols, and the question of who benefits most from which treatment.

^{[12]}This study is reported using CONSORT Extension checklist for non-inferiority and equivalence trials.

^{[13]}Food and Drug Administration recommend equivalence trials to demonstrate biosimilarity (2, 16).

^{[14]}The CONSORT (consolidated standards of reporting trials) statement for noninferiority and equivalence trials clearly states, “Failure to show a difference does not mean they are equivalent.

^{[15]}However, routine bioequivalence trials using subjects with normal gastric pH (i.

^{[16]}Guidelines for paediatric bioequivalence trials are warranted.

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