non-inferiority trial
A clinical trial design that aims to demonstrate a new treatment is not worse than standard therapy by more than a predefined margin.
Full Definition
Non-inferiority trials are designed to show that a new intervention is not unacceptably worse than an established standard of care, rather than demonstrating superiority. These trials are common in cardiovascular research when testing safer, more convenient, or cost-effective alternatives to proven therapies. The non-inferiority margin must be pre-specified based on clinical judgment and regulatory guidance, typically preserving a substantial portion of the active control's effect versus placebo. Statistical analysis focuses on the upper confidence limit of the treatment difference, with non-inferiority declared if this limit lies below the pre-defined margin. Both intention-to-treat and per-protocol analyses are typically required.
Usage
Usage note: Always hyphenate; clearly distinguish from superiority and equivalence trials in methodology sections.
In Context
- "The non-inferiority trial established a margin of 1.5% for the primary safety endpoint." — Protocol synopsis
- "Non-inferiority was demonstrated with the upper 95% confidence limit of -0.8% (margin: 2.0%)." — Statistical results