Points to Consider on Switching between Superiority and Non-inferiority & Guideline on the Choice of Non-inferiority Margin への討論 [in Japanese] Discussion about Points to Consider on Switching between Superiority and Non-inferiority & Guideline on the Choice of Non-inferiority Margin [in Japanese]
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Two guidelines related to non-inferiority trials were released by the European Medicines Agency (EMEA). One pertains to the choice of non-inferiority margin and the other to switching the objective of a trial between superiority and non-inferiority. These guidelines describe principles for appropriately designing and interpreting non-inferior trials, but it is very difficult to follow these principles in an actual clinical trial setting. In this article, recommendations in interpreting these guidelines are discussed from a sponsor statisticians' point of view. Some issues of non-inferior trials not mentioned in these guidelines are also discussed.
- Japanese Journal of Biometrics
Japanese Journal of Biometrics 27, S105-S115, 2006-09-30
The Biometric Society of Japan