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Sample Size for HIV-1 Vaccine Clinical Trials with Extremely Low Incidence Rate

Shein-Chung Chow

Duke University School of Medicine, Durham, NC

Yuanyuan Kong

Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China

National Clinical Research Center for Digestive Disease, Beijing, People's Republic of China

Shih-Ting Chiu

Providence St. Vincent Medical Center, Portland, OR

CONTENTS

2.1 Introduction...................................................................................................17
2.2 Sample Size Determination.........................................................................20
2.2.1 Power Analysis...................................................................................20
2.2.2 Precision Analysis..............................................................................21
2.2.3 Remarks...............................................................................................22
2.2.4 Chow and Chiu's Procedure for Sample Size Estimation...........23
2.3 Sensitivity Analysis......................................................................................25
2.4 An Example...................................................................................................26
2.5 Data Safety Monitoring Procedure............................................................29
2.6 Concluding Remarks....................................................................................38

References...............................................................................................................38

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Sample Size Considerations for a Two-Group Clinical Trial
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Application of HIV-1 Vaccine Trials
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A. Sample Size
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