Section I Quantitative Methods for Clinical Trials and Epidemiology

Taylor &. Francis

Taylor & Francis Group

http://taylorandfrancis.com

Statistical Issues in HIV Non-Inferiority Trials

Mimi Kim

Albert Einstein College of Medicine, Bronx, NY

CONTENTS

• 1.1 Introduction.....................................................................................................3
• 1.2 Margin of Non-Inferiority.............................................................................5
• 1.3 Analysis of NI Trials......................................................................................7
• 1.4 Sample Size Determination...........................................................................9
• 1.5 Other Considerations in NI Trials..............................................................10
• 1.5.1 Noncompliance...................................................................................11
• 1.5.2 Missing Data.......................................................................................12
• 1.5.3 Misclassification and Measurement Error in

Outcome Variables............................................................................13

1.6 Summary........................................................................................................14

References...............................................................................................................15