{"entity":{"id":"non-inferiority","kind":"term","name":"Non-inferiority trial","aka":["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"],"tldr":"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.","asOf":"2026-09-09","wikipedia":"https://en.wikipedia.org/wiki/Non-inferiority_trial","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Non-inferiority_trial"}],"tags":[],"related":["de-escalation","hypofractionation","intention-to-treat","statistical-significance","non-inferiority-margin","randomised-trial","stepped-wedge-design","estimand","trial-failure-modes"],"cancers":[],"sections":["drug-discovery"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["sano","persephone","fast-forward","pace-b","tailorx","dynamic","convert"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Trials"},"route":"/terms/non-inferiority/","neighbours":{"term":[{"id":"control-arm","kind":"term","name":"Control arm and comparator (investigator's choice)","route":"/terms/control-arm/"},{"id":"de-escalation","kind":"term","name":"De-escalation, escalation and response-adapted therapy","route":"/terms/de-escalation/"},{"id":"estimand","kind":"term","name":"Estimands and intercurrent events (ICH E9(R1))","route":"/terms/estimand/"},{"id":"hypofractionation","kind":"term","name":"Hypofractionation (fewer, larger radiotherapy doses)","route":"/terms/hypofractionation/"},{"id":"intention-to-treat","kind":"term","name":"Intention-to-treat (ITT) and per-protocol analysis","route":"/terms/intention-to-treat/"},{"id":"non-inferiority-margin","kind":"term","name":"Non-inferiority margin and equivalence trials","route":"/terms/non-inferiority-margin/"},{"id":"trial-phases","kind":"term","name":"Phase 1, 2 and 3 trials","route":"/terms/trial-phases/"},{"id":"randomised-trial","kind":"term","name":"Randomised trial","route":"/terms/randomised-trial/"},{"id":"statistical-significance","kind":"term","name":"Statistical significance (P values, alpha, multiplicity)","route":"/terms/statistical-significance/"},{"id":"stepped-wedge-design","kind":"term","name":"Stepped-wedge design","route":"/terms/stepped-wedge-design/"},{"id":"trial-failure-modes","kind":"term","name":"Why trials fail: underpowered, wrong endpoint, control arm drift, subgroup fishing, crossover","route":"/terms/trial-failure-modes/"}],"section":[{"id":"drug-discovery","kind":"section","name":"Drug Discovery Platforms","route":"/fronts/drug-discovery/"}],"trial":[{"id":"ahl2011","kind":"trial","name":"AHL2011","route":"/trials/ahl2011/"},{"id":"convert","kind":"trial","name":"CONVERT","route":"/trials/convert/"},{"id":"dynamic","kind":"trial","name":"DYNAMIC","route":"/trials/dynamic/"},{"id":"eortc-h10","kind":"trial","name":"EORTC/LYSA/FIL H10","route":"/trials/eortc-h10/"},{"id":"fast-forward","kind":"trial","name":"FAST-Forward","route":"/trials/fast-forward/"},{"id":"flyer","kind":"trial","name":"FLYER","route":"/trials/flyer/"},{"id":"fortplus","kind":"trial","name":"FORTplus","route":"/trials/fortplus/"},{"id":"hd18","kind":"trial","name":"GHSG HD18","route":"/trials/hd18/"},{"id":"pace-b","kind":"trial","name":"PACE-B","route":"/trials/pace-b/"},{"id":"persephone","kind":"trial","name":"PERSEPHONE","route":"/trials/persephone/"},{"id":"sano","kind":"trial","name":"SANO","route":"/trials/sano/"},{"id":"tailorx","kind":"trial","name":"TAILORx","route":"/trials/tailorx/"}],"paper":[{"id":"paper-eortc-h10-pet-adapted-early-hodgkin-jco-2017","kind":"paper","name":"Early positron emission tomography response-adapted treatment in stage I and II Hodgkin lymphoma: final results of the randomized EORTC/LYSA/FIL H10 trial","route":"/key-papers/paper-eortc-h10-pet-adapted-early-hodgkin-jco-2017/"},{"id":"paper-flyer-four-vs-six-cycles-r-chop-lancet-2019","kind":"paper","name":"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)","route":"/key-papers/paper-flyer-four-vs-six-cycles-r-chop-lancet-2019/"},{"id":"paper-ahl2011-pet-adapted-treatment-advanced-hodgkin-lancet-oncol-2019","kind":"paper","name":"PET-adapted treatment for newly diagnosed advanced Hodgkin lymphoma (AHL2011): a randomised, multicentre, non-inferiority, phase 3 study","route":"/key-papers/paper-ahl2011-pet-adapted-treatment-advanced-hodgkin-lancet-oncol-2019/"},{"id":"paper-ghsg-hd18-pet-guided-escalated-beacopp-lancet-2017","kind":"paper","name":"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","route":"/key-papers/paper-ghsg-hd18-pet-guided-escalated-beacopp-lancet-2017/"}]}}