Jan 7, 2006

Superior safety in noninferiority trials

Biometrical Journal. Biometrische Zeitschrift
David R Bristol

Abstract

Noninferiority of a new treatment to a reference treatment with respect to efficacy is usually associated with the superiority of the new treatment to the reference treatment with respect to other aspects not associated with efficacy. When the superiority of the new treatment to the reference treatment is with respect to a specified safety variable, it may be necessary to perform the between-treatment comparisons. The efficacy and safety comparisons may be considered separately or simultaneous comparisons may be performed. Here techniques are discussed for the simultaneous consideration of both aspects.

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Citations

Mentioned in this Paper

Confidence Intervals
Data Interpretation, Statistical
Drug Evaluation
Pharmacotherapy
Therapeutic Equivalency
Biopharmaceutics

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