Premium
How to establish equivalence between treatments: A one‐sided clinical trial in paediatric oncology
Author(s) -
Rodary Chantal,
ComNougue Catherine,
Tournade MarieFrance
Publication year - 1989
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.4780080508
Subject(s) - equivalence (formal languages) , medicine , null hypothesis , clinical trial , oncology , statistics , mathematics , discrete mathematics
The design of a clinical trial to establish the equivalence of two treatments differs from that of an efficacy trial. The conventional null hypothesis of equivalent treatment efficacy is replaced by a null hypothesis of inequivalence which must be tested by appropriate statistics. In addition, the maximum allowable value of the true difference between the efficacy of two equivalent treatments must be specified. In oncology, such a trial is necessary when a standard treatment is replaced by a new less toxic one of equivalent efficacy. The statistical formulation is one‐sided. A trial comparing two pre‐operative treatments in childhood nephroblastoma is presented here and analysed according to this methodology.