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520slide - ST 520 D Zhang ST 520 Statistical Principles of...

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ST 520 D. Zhang ST 520: Statistical Principles of Clinical Trials and Epidemiology Daowen Zhang [email protected] http://www4.stat.ncsu.edu/ dzhang2 Slide 1
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TABLE OF CONTENTS ST520, D. Zhang Contents 1 Introduction 5 1.1 Brief Introduction to Epidemiology . . . . . . . . . . . . . 7 1.2 Brief Introduction and History of Clinical Trials . . . . . . 29 2 Phase I and Phase II Clinical Trials 42 2.1 Phase I clinical trials (from Dr. Marie Davidian) . . . . . . 44 2.2 Phase II Clinical Trials . . . . . . . . . . . . . . . . . . . . 99 3 Phase III Clinical Trials 133 4 Randomization 159 5 Some Additional Issues in Phase III Clinical Trials 201 6 Sample Size Calculations 209 7 Comparing More Than Two Treatments 234 Slide 2
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TABLE OF CONTENTS ST520, D. Zhang 8 Causality, Non-compliance and Intent-to-treat 275 8.1 Causality and Counterfactual Random Variables . . . . . . 275 8.2 Noncompliance and Intent-to-treat analysis . . . . . . . . 282 8.3 A Causal Model with Noncompliance . . . . . . . . . . . . 288 9 Survival Analysis in Phase III Clinical Trials 300 9.1 Describing the Distribution of Time to Event . . . . . . . 301 9.2 Censoring and Life-Table Methods . . . . . . . . . . . . . 310 9.3 Kaplan-Meier or Product-Limit Estimator . . . . . . . . . 320 9.4 Two-sample Log-rank Tests . . . . . . . . . . . . . . . . . 326 9.5 Power and Sample Size Based on the Log-rank Test . . . . 336 9.6 K-Sample Log-rank Tests . . . . . . . . . . . . . . . . . . 352 9.7 Sample-size Considerations for the K-sample Log-rank Test 355 9.8 Analyzing Data Using K -sample Log-rank Test . . . . . . 357 10 Early Stopping of Clinical Trials 360 10.1 General Issues in Monitoring Clinical Trials . . . . . . . . . 360 Slide 3
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TABLE OF CONTENTS ST520, D. Zhang 10.2 Information Based Design and Monitoring . . . . . . . . . 366 10.3 Choice of Boundaries . . . . . . . . . . . . . . . . . . . . 382 10.4 Power and Sample Size in Terms of Information . . . . . . 388 Slide 4
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CHAPTER 1 ST 520, D. Zhang 1 Introduction Two areas of studies on human beings: EPIDEMIOLOGY and CLINICAL TRIALS EPIDEMIOLOGY : Systematic study of disease etiology (causes and origins of disease) using 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 Slide 5
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CHAPTER 1 ST 520, D. Zhang 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) Slide 6
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CHAPTER 1 ST 520, D. Zhang 1.1 Brief Introduction to Epidemiology I. Cross-sectional study : data are obtained from a random sample at one point in time. This gives a snapshot of a population. Example : Based on a survey or a random sample thereof, we determine the proportion of individuals with heart disease at one time point. This is referred to as the prevalence of disease. The prevalence can be broken down by age, race, sex, socio-economic status, geographic, etc.
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