{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,21]],"date-time":"2026-02-21T13:09:39Z","timestamp":1771679379536,"version":"3.50.1"},"reference-count":11,"publisher":"Scientific Scholar","content-domain":{"domain":["nmji.in"],"crossmark-restriction":true},"short-container-title":["NMJI"],"abstract":"<jats:p>Randomized controlled trials (RCTs) are the gold standard design of studies evaluating novel interventions, pharmaceutical and otherwise. The standard RCT design is a \u2018superiority\u2019 study to assess if the tested intervention is better than existing treatments. However, a new intervention that has additional benefits, such as better adverse effect profile, may be useful even if it is not more effective than existing treatments. In such cases, a non-inferiority (NI) design may be preferable. In NI designs, once NI is demonstrated, sequential analysis for superiority may be done, provided it is pre-specified. This article discusses the utility and principles of an NI design. Examples to illustrate the design are taken from published trials of anticoagulation in atrial fibrillation.<\/jats:p>","DOI":"10.25259\/nmji_1051_2024","type":"journal-article","created":{"date-parts":[[2026,2,21]],"date-time":"2026-02-21T12:39:01Z","timestamp":1771677541000},"page":"120-123","update-policy":"https:\/\/doi.org\/10.25259\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Non-inferiority clinical trials: What they are and when they should be done"],"prefix":"10.25259","volume":"39","author":[{"given":"PREM","family":"PAIS","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"10894","published-online":{"date-parts":[[2026,2,21]]},"reference":[{"key":"10.25259\/NMJI_1051_2024\/ref-1","doi-asserted-by":"publisher","first-page":"54","DOI":"10.1056\/NEJMra1112570","article-title":"A tale of coronary artery disease and myocardial infarction","volume":"366","author":"Nabel","year":"2012","journal-title":"N 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