Clinical Trials: A Practical Guide to Design, Analysis, and Reporting

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Remedica, 2006 - Medical - 480 pages
The author takes a back-to-basics approach to explaining statistics specifically for a medically literate audience. Each article provides essential background information to each topic, explores its meaning, and explains how and when it should be applied. Medical students, statistics students, clinical researchers, pharmaceutical sales representatives Statistics are complicated, but to a large extent this is a reflection of the way in which they are taught. In this book, Dr Bahkar takes a back-to-basics approach to explaining statistics specifically for a medically literate audience. Based on the successful "Practical Issues in Clinical Trial Design" series published in Remedica's flagship journal Clinical Researcher, and supplemented by key contributions from other leading international experts, each article provides essential background information to each topic, explores its meaning, and explains how and when it should be applied. Readers will gain not only an understanding of the basics of medical statistics, but also critical insight into how to review and evaluate clinical trial evidence.
 

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Contents

Introduction
IntentiontoTreat Analysis 255
Subgroup Analysis 265
Randomized Clinical Trials 1
Endpoints 37
Patient Selection 47
Blinding 75
Sample Size and Power 81
Confounding 295
Repeated Measurements 317
Multiplicity 329
Missing Data 339
Interim Monitoring and Stopping Rules 353
Reporting of Trials
Overview of Reporting 365
Trial Profile 377

Factorial Design 101
Bioequivalence Trials 119
Cluster Randomized Trials 141
Types of Data and Normal Distribution 167
Regression Analysis 273
Significance Tests and Confidence Intervals 185
Comparison of Proportions 217
Analysis of Survival Data 235
Adjustment for Covariates 287
Presenting Baseline Data 385
Use of Tables 391
Use of Figures 407
Critical Appraisal of a Report 427
MetaAnalysis 439
Glossary 453
Abbreviations 461
Index 467
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