On non-inferiority analysis based on delta-method confidence intervals.

  title={On non-inferiority analysis based on delta-method confidence intervals.},
  author={Mark D. Rothmann and H H Tsou},
  journal={Journal of biopharmaceutical statistics},
  volume={13 3},
For many indications where there is an effective standard therapy, active controlled trials are generally conducted when it is unethical to use a placebo. The efficacy objective of most such trials is the demonstration that the experimental therapy has superior efficacy to the active-control. The efficacy objective of a non-inferiority trial may be to rule out that the experimental treatment loses some prespecified fraction of the active-control effect. The size of the active-control effect may… CONTINUE READING

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