Rev Epidemiol Sante
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Rev Epidemiol Sante · Aug 2008
Review[Methodological and statistical aspects of equivalence and non inferiority trials].
- The existence of effective reference treatments means that the superior therapeutic efficacy of new treatments is less marked and thus more difficult to demonstrate statistically. Moreover, the potential value of a new treatment is also based on other criteria, such as costs, ease of use, non invasiveness, and immediate or long-term side effects. In this context, methodological issue becomes one of looking for equivalence or non inferiority of the new treatment in comparison with an existing, high-performance reference treatment. ⋯ - A checklist of items to include when reporting the results of randomized controlled trials (Consolidated Standards of Reporting Trials, the CONSORT recommendations) has been adapted for use in non inferiority and equivalence randomized controlled trials.