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Non-Inferiority Clinical Trials to Establish Effectiveness
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- Biomarkers as drug development tools: discovery, validation, qualification and use
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- Non-Inferiority Clinical Trials to Establish Effectiveness
- FDA Approval Process
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Non-Inferiority Clinical Trials to Establish Effectiveness
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- Guidance to sponsors and applicants submitting investigational drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of non-inferiority (N.I.) study designs to provide evidence of a drug’s or biologic’s effectiveness, usually because a superiority study design (drug versus placebo, dose response, or sup) study design (drug versus placebo, dose response, or sup) study design ( When N.I. Studies designed to illustrate the efficacy of an experimental medication can yield interpretable findings, how to determine the N.I. Margin, and how to test the N.I. The hypothesis is all covered in the recommendations.
- I. research designs for evaluating the safety of a medication is not recommended in this advice. The FDA’s guideline documents, in general, do not impose legally enforceable requirements. Instead, guidance materials represent the Agency’s current thinking on an issue and should only be considered suggestions unless specific regulatory or statutory requirements are referenced. In FDA guidance documents, the term “should” denotes “advised” or “preferred,” but not “mandated.”
- The FDA’s requirements on sufficient and well-controlled studies (21 CFR 314.126) outline four different types of simultaneously controlled trials that offer evidence of efficacy. Three of these — placebo, no treatment, and dose-response controlled trials — are superiority studies in which a test medicine is compared to a controlled drug (placebo, no treatment, or a lower dose of the test drug). Suppose the goal is to prove that the new medicine is more effective than the control. In that case, the fourth kind, compared with an active therapy (active control), might also be a superior trial.
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References
Fleming, T.R. (2011). “Some Essential Considerations in the Design and Conduct of Non-inferiority Trials.” Clinical Trials 8, 432-439.
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