Retrospective Assessment of Non-Inferiority in the Rare Disease, Guillain–Barre Syndrome
نویسندگان
چکیده
After a non-inferiority margin is established, a prospective non-inferiority trial is usually conducted to confirm the noninferiority of the new product when compared to the existing product. Non-inferiority trials typically require considerably larger sample sizes than placebo-controlled trials [4]. This is due to the fact that the margin of equivalence (non-inferiority) is often much smaller than the treatment difference, which a placebo-controlled trial must be powered to detect. It is therefore important for non-inferiority trials to have large sample sizes, and for this reason, trials of orphan drugs in rare diseases face significant challenges in terms of recruiting sufficient sample sizes to formally assess prospectively defined non-inferiority and of completing the trial within a realistic timeframe.
منابع مشابه
Guillain-Barre Syndrome: A Retrospective Study of Clinical and Epidemiological Features in Kurdistan, West of Iran, From 2005 To 2014
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