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  • Title: Randomized clinical trial design for assessing noninferiority when superiority is expected.
    Author: Freidlin B, Korn EL, George SL, Gray R.
    Journal: J Clin Oncol; 2007 Nov 01; 25(31):5019-23. PubMed ID: 17971602.
    Abstract:
    The randomized clinical trial (RCT) is the gold standard for definitive evaluation of new therapies. RCTs designed to show that the therapeutic efficacy of a new therapy is not unacceptably inferior to that of standard therapy are called noninferiority trials. Traditionally, noninferiority trials have required very large sample sizes. Sometimes, a new treatment regimen with a favorable toxicity and/or tolerability profile is also expected to have some modest improvement in efficacy. In such specialized settings we describe a hybrid trial-design approach that requires a dramatically smaller sample size than that of a standard noninferiority design. This hybrid design can naturally incorporate a formal test of superiority as well as noninferiority.
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