Table of Contents
Active Control Non-Inferiority Studies: Theory, Assay Sensitivity, Choice of Margin
History of FDA Interest in Non-Inferiority Trials
ICH
Guidance of Interest
Evidence of Efficacy
Equivalence/Non-Inferiority
Evidence of Efficacy
Assay Sensitivity
Active Control Trials
Fundamental Logic of Trials
Assuring Assay Sensitivity in Non-Inferiority Trials
Sensitivity to Drug Effects/Assay Sensitivity
Historical Evidence of Sensitivity to Drug Effects
Historical Evidence of Sensitivity to Drug Effects: a Precondition for Assay Sensitivity
Assay Sensitivity and Study Quality
Assay Sensitivity and Study Quality
Historical Evidence of Sensitivity to Drug Effects
Choosing a Non-Inferiority Margin
Null and Alternative Hypotheses
Choice of M1 is Crucial
Choosing a Non-Inferiority Margin
PPT Slide
Confusion of M1 and M2
M1 vs. M2
Choice of Margin (M2)
M1 for Anti-infectives
ICH E10 - Ethics of Placebo Control
Use of Placebo Control
Use of Placebo Control
Placebo Controls in Infectious Diseases
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