ST 520 Statistical Principles of Clinical Trials - NCSU Statistics ...

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TABLE OF CONTENTS ST 520, A. Tsiatis and D. Zhang 9.4 Two-sample Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144 9.5 Power and Sample Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149 9.6 K-Sample Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157 9.7 Sample-size considerations for the K-sample logrank test . . . . . . . . . . . . . . 160 10 Early Stopping of Clinical Trials 164 10.1 General issues in monitoring clinical trials . . . . . . . . . . . . . . . . . . . . . . 164 10.2 Information based design and monitoring . . . . . . . . . . . . . . . . . . . . . . . 167 10.3 Type I error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171 10.3.1 Equal increments of information . . . . . . . . . . . . . . . . . . . . . . . . 175 10.4 Choice of boundaries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177 10.4.1 Pocock boundaries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178 10.4.2 O’Brien-Fleming boundaries . . . . . . . . . . . . . . . . . . . . . . . . . . 179 10.5 Power and sample size in terms of information . . . . . . . . . . . . . . . . . . . . 181 10.5.1 Inflation Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184 10.5.2 Information based monitoring . . . . . . . . . . . . . . . . . . . . . . . . . 188 10.5.3 Average information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189 10.5.4 Steps in the design and analysis of group-sequential tests with equal increments of information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193 iii
CHAPTER 1 ST 520, A. TSIATIS and D. Zhang 1 Introduction 1.1 Scope and objectives The focus of this course will be on the statistical methods and principles used to study disease and its prevention or treatment in human populations. There are two broad subject areas in the study of disease; Epidemiology and Clinical Trials. This course will be devoted almost entirely to statistical methods in Clinical Trials research but we will first give a very brief introduction to Epidemiology in this Section. EPIDEMIOLOGY: Systematic study of disease etiology (causes and origins of disease) us- ing observational data (i.e. data collected from a population not under a controlled experimental setting). • Second hand smoking and lung cancer • Air pollution and respiratory illness • Diet and Heart disease • Water contamination and childhood leukemia • Finding the prevalence and incidence of HIV infection and AIDS CLINICAL TRIALS: The evaluation of intervention (treatment) on disease in a controlled experimental setting. • The comparison of AZT versus no treatment on the length of survival in patients with AIDS • Evaluating the effectiveness of a new anti-fungal medication on Athlete’s foot • Evaluating hormonal therapy on the reduction of breast cancer (Womens Health Initiative) PAGE 1
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