Drug Regulators, FDA, Publish Draft Guidance for Industry, Non-Inferiority Clinical Trials

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This guidance provides sponsors and review staff in the Center for Drug Evaluation and Research (CDER) and Center for Biologic Evaluation and Research (CBER) at the Food and Drug Administration (FDA) with our interpretation of the underlying principles involved in the use of non-inferiority (NI) study designs to provide evidence of the effectiveness of a drug or biologic. The guidance gives advice on when NI studies can be interpretable, on how to choose the NI margin, and how to analyze the results.

This guidance consists of four parts. The first part is a general discussion of regulatory, study design, scientific, and statistical issues associated with the use of non-inferiority studies when these are used to establish the effectiveness of a new drug. The second part focuses on some of these issues in more detail, notably the quantitative analytical and statistical approaches used to determine the non-inferiority margin for use in NI studies, as well as the advantages and disadvantages of available methods. The third part addresses commonly asked questions about NI studies and provides practical advice about various approaches.  The fourth part includes five examples of successful and unsuccessful efforts to define non inferiority margins and conduct NI studies.

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