caa a22 4500 469121580 CHVBK 20180323133140.0 cr unu---uuuuu 170328e19920201xx s 000 0 eng 10.1007/BF02246246 doi (NATIONALLICENCE)springer-10.1007/BF02246246 Active control equivalence trials: some methodological aspects [Elektronische Daten] [U. Ferner, N. Neumann] The therapeutic efficacy of an investigational new drug is best demonstrated in clinical trials against a placebo control. However, ethical requirements increasingly preclude the use of an inactive control substance as a treatment alternative, as clinical testing to compare the effects of active treatments, has become more frequent. The statistical evaluation and interpretation of these trials is complex and requires the demonstration of ‘equivalence' or ‘at-least equivalence' between the experimental drug and a comparable standard therapy. The design of controlled clinical trials to compare the effects of moclobemide, a new and selective monoamine oxidase-A inhibitor, with those of standard tricyclic antidepressant drugs involved the refinement of selection strategies, formulation of hypotheses, means of statistical analysis and clinical interpretation. Springer-Verlag, 1992 Equivalence testing nationallicence Active control study design nationallicence Moclobemide nationallicence Clinical trial methodology nationallicence Ferner U. Department of Clinical Research, Biometrics, F. Hoffmann-La Roche Ltd, CH-4002, Basel, Switzerland aut Neumann N. Department of Clinical Research, Biometrics, F. Hoffmann-La Roche Ltd, CH-4002, Basel, Switzerland aut Psychopharmacology Springer-Verlag 106(1992-02-01), S93-S95 0033-3158 106<S93 1992 106 213 https://doi.org/10.1007/BF02246246 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/BF02246246 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Ferner U. Department of Clinical Research, Biometrics, F. Hoffmann-La Roche Ltd, CH-4002, Basel, Switzerland aut NATIONALLICENCE 700 1- Neumann N. Department of Clinical Research, Biometrics, F. Hoffmann-La Roche Ltd, CH-4002, Basel, Switzerland aut NATIONALLICENCE 773 0- Psychopharmacology Springer-Verlag 106(1992-02-01), S93-S95 0033-3158 106<S93 1992 106 213 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer