机译:Issues with Statistical Risks for Testing Methods in Noninferiority Trial Without a Placebo ARM
Division of Biometrics I, Office of Biostatistics, OTS/CDER, FDA. Silver Spring, MD. USA;
Office of Biostatistics, OTS/CDER, FDA. Silver Spring, MD. USA;
Across-trial or unconditional Type I error rate; Active-controlled; Fixed margin method; Noninferiority margin; Placebo-controlled; Within-trial or conditional Type I error rate; Synthesis method;