Active Control Non-Inferiority Studies: Theory, Assay Sensitivity, Choice of Margin

2/25/02


Click here to start


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

Author: Sandra Benton