China CDE Releases a Guideline on Non-Inferiority Clinical Trials for Drugs

Effective from 24 July 2020 onward, the Center for Drug Evaluation(CDE) of China releases a guideline on Non-Inferiority Clinical Trials for Drugs to promote the correct understanding, implementation, and evaluation of non-inferiority design by all relevant parties in clinical trials, and to standardize sponsors to carry out non-inferiority trials.

The superiority testing (such as proving the superiority of the test drug compared to a placebo or positive drug) is generally an ideal choice to confirm the efficacy of a drug.

When superiority trials are not applicable, for example, the use of placebo controls does not meet ethical requirements, non-inferiority trials can be considered.

The non-inferiority test is to confirm the clinical efficacy of the test drug, even if it is lower than the positive control drug, the difference is still within the clinically acceptable range.

This guideline aims to describe the application conditions, design points, non-inferiority threshold setting, statistical inference, and other regulatory considerations of non-inferiority trials in order to guide the relevant parties in clinical trials to correctly understand, implement and evaluate Non-Inferiority test.

This guideline is mainly applicable for confirmatory clinical trials that support drug registration and marketing, and can also be used as well for reference for exploratory clinical trials.

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