# Non-inferiority trial

Source: https://onco.cc/terms/non-inferiority/  
OnCo record `non-inferiority` (Term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A trial designed to show a new treatment is not meaningfully worse than the standard, rather than better: used when the new option is shorter, cheaper, less toxic or easier (five radiotherapy fractions instead of 25, six months of trastuzumab instead of twelve).

## Summary

The sponsor pre-specifies a non-inferiority margin (the largest loss of efficacy considered acceptable, e.g. a hazard ratio upper confidence limit below 1.2) and the trial succeeds if the confidence interval excludes that margin. Because a bad trial (poor adherence, wrong population) tends toward no difference, non-inferiority trials must be run rigorously and are analysed per-protocol as well as intention-to-treat. They underpin most de-escalation (hypofractionation, IDEA 3 vs 6 months FOLFOX, PERSEPHONE, segmentectomy vs lobectomy, SANO active surveillance) and biosimilar approvals. Choosing the margin is contentious: a 'non-inferior' result can still mean some patients are harmed.

## Fields

- Kind: Term
- Last checked: 2026-09-09
- Also known as: non-inferiority; noninferiority; non-inferior; noninferior; non-inferiority margin; non-inferiority trial; non-inferiority design; met non-inferiority; superiority; superiority trial; superiority design; equivalence; equivalence trial; non-inferiority designs; non-inferiority margins; non-inferiority trials

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Non-inferiority_trial
- Wikipedia: https://en.wikipedia.org/wiki/Non-inferiority_trial

## Connected records

- terms: [Control arm and comparator (investigator's choice)](https://onco.cc/terms/control-arm/), [De-escalation, escalation and response-adapted therapy](https://onco.cc/terms/de-escalation/), [Estimands and intercurrent events (ICH E9(R1))](https://onco.cc/terms/estimand/), [Hypofractionation (fewer, larger radiotherapy doses)](https://onco.cc/terms/hypofractionation/), [Intention-to-treat (ITT) and per-protocol analysis](https://onco.cc/terms/intention-to-treat/), [Non-inferiority margin and equivalence trials](https://onco.cc/terms/non-inferiority-margin/), [Phase 1, 2 and 3 trials](https://onco.cc/terms/trial-phases/), [Randomised trial](https://onco.cc/terms/randomised-trial/), [Statistical significance (P values, alpha, multiplicity)](https://onco.cc/terms/statistical-significance/), [Stepped-wedge design](https://onco.cc/terms/stepped-wedge-design/), [Why trials fail: underpowered, wrong endpoint, control arm drift, subgroup fishing, crossover](https://onco.cc/terms/trial-failure-modes/)
- fronts: [Drug Discovery Platforms](https://onco.cc/fronts/drug-discovery/)
- trials: [AHL2011](https://onco.cc/trials/ahl2011/), [CONVERT](https://onco.cc/trials/convert/), [DYNAMIC](https://onco.cc/trials/dynamic/), [EORTC/LYSA/FIL H10](https://onco.cc/trials/eortc-h10/), [FAST-Forward](https://onco.cc/trials/fast-forward/), [FLYER](https://onco.cc/trials/flyer/), [FORTplus](https://onco.cc/trials/fortplus/), [GHSG HD18](https://onco.cc/trials/hd18/), [PACE-B](https://onco.cc/trials/pace-b/), [PERSEPHONE](https://onco.cc/trials/persephone/), [SANO](https://onco.cc/trials/sano/), [TAILORx](https://onco.cc/trials/tailorx/)
- key papers: [Early positron emission tomography response-adapted treatment in stage I and II Hodgkin lymphoma: final results of the randomized EORTC/LYSA/FIL H10 trial](https://onco.cc/key-papers/paper-eortc-h10-pet-adapted-early-hodgkin-jco-2017/), [Four versus six cycles of CHOP chemotherapy in combination with six applications of rituximab in patients with aggressive B-cell lymphoma with favourable prognosis (FLYER)](https://onco.cc/key-papers/paper-flyer-four-vs-six-cycles-r-chop-lancet-2019/), [PET-adapted treatment for newly diagnosed advanced Hodgkin lymphoma (AHL2011): a randomised, multicentre, non-inferiority, phase 3 study](https://onco.cc/key-papers/paper-ahl2011-pet-adapted-treatment-advanced-hodgkin-lancet-oncol-2019/), [PET-guided treatment in patients with advanced-stage Hodgkin's lymphoma (HD18): final results of an open-label, international, randomised phase 3 trial by the German Hodgkin Study Group](https://onco.cc/key-papers/paper-ghsg-hd18-pet-guided-escalated-beacopp-lancet-2017/)

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