When planning a noninferiority trial, one should adequately understand its concept and the possible drawbacks. How to design and interpret the results of such studies so that they can support a. This guidance finalizes the draft guidance for industry, noninferiority clinical trials, published in 2010. Non inferiority clinical trials are being performed with an increasing frequency nowadays, because it helps in finding a new treatment that have approximately the same efficacy, but may offer other benefits such as better safety profile. The guidance briefly discusses alternative designs that may be preferable in these situations, including addon studies, carefully selected patient. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials.
Design issues edgar r miller iii phd, md welch center for prevention, epidemiology and clinical research johns hopkins university school of medicine and bloomberg school of public health 2 type of studies nonexperimental observational case report case series crosssectional survey. Critical issues in the design and conduct of noninferiority trials include. Pdf the noninferiority trial design has gained popularity within the last decades to compare a. Noninferiority trials attempt to establish whether or not a new treatment drug or nondrug is no worse than an established treatment for which efficacy has been determined in placebocontrolled trials. Statistical grand rounds equivalence and noninferiority. Consort extension for noninferiority and equivalence trials. Noninferiority trials are experimental models designed to determine whether a new treatment or. Statistical grand rounds equivalence and noninferiority testing in regression. Non inferiority studies are used to show that a minimum level of efficacy has been achieved. Noninferiority trial, controlled clinical trials, randomized controlled. Superiority trials are always used when comparisons are made to placebo or vehicle treatments.
Noninferiority trials are more complex to design, conduct, and interpret. In this paper, we want to develop some designs for. In comparison studies with a current therapy, non inferiority is used to demonstrate that the new therapy provides at least the same benefit to the patient. Pdf design of phase ii noninferiority trials researchgate. The noninferiority trial design has gained popularity within the last decades to compare a new treatment to the standard active control.
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