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Updated: Jul 29, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Superior safety in noninferiority trials
1Purdue Pharma LP, Cranbury, New Jersey, USA. drbris@msn.com
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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