Samples size calculation (N per group) for non-inferiority trials.

Success rate ranging 60–90%; exclusions ranging 0–25%; non-inferiority margin (delta) 6%, 8% and 10%.

Figshare2015-12-02 更新00

Sample size calculations for non-inferiority trials.

Efficacy in the reference arm from 80%–95%, delta 5–10%, alpha error 0.01, power 90%.The Non-inferiority margin represents the smallest acceptable difference with respect to the success rate with the

Figshare2015-12-02 更新10

Conceptual and practical aspects of the frequentist and the decision theory approach of sample size estimation for non-inferiority trials.

NIAID Data Ecosystem10