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Contents
1 Introduction to Clinical Trials.................................................................. 1
2 Ethical Issues.............................................................................................. 19
3 What Is the Question?............................................................................... 37
4 Study Population........................................................................................ 55
5 Basic Study Design..................................................................................... 67
6 The Randomization Process...................................................................... 97
7 Blindness..................................................................................................... 119
8 Sample Size................................................................................................. 133
9 Baseline Assessment................................................................................. 169
10 Recruitment of Study Participants......................................................... 183
11 Data Collection and Quality Control..................................................... 199
12 Assessing and Reporting Adverse Events.............................................. 215
13 Assessment of Health-Related Quality of Life....................................... 233
14 Participant Adherence............................................................................. 251
15 Survival Analysis...................................................................................... 269
16 Monitoring Response Variables.............................................................. 293
17 Issues in Data Analysis............................................................................ 345
18 Closeout..................................................................................................... 399
19 Reporting and Interpreting of Results................................................... 411
20 Multicenter Trials.................................................................................... 427
Fundamentals of Clinical Trials.pdf
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