Statistics Applied to Clinical Trials

✍ Scribed by Ton J. Cleophas MD, PhD, Associate-Professor, Aeilko H. Zwinderman Math D, PhD, Professor, Toine F. Cleophas D Techn (auth.)

• Publisher: Springer Netherlands
• Year: 2006
• Tongue: English
• Leaves: 363
• Edition: 3
• Category: Library

✦ Synopsis

From the reviews of the fourth edition:

"Readership: Students, physicians and investigators interested in statistical methods for clinical trials. This book was originally written for a course in medical statistics given in the EU sponsored program European Interuniversity Diploma of Pharmaceutical Medicine starting in the year 2000. … it has been expanded and updated in order to serve as a guide and reference-text to students, physicians and investigators." (Andreas Rosenblad, International Statistical Review, Vol. 77 (3), 2009)

✦ Table of Contents

Front Matter....Pages i-xv
Hypotheses, Data, Stratification....Pages 1-16
The Analysis of Efficacy Data of Drug Trials....Pages 17-39
The Analysis of Safety Data of Drug Trials....Pages 41-58
Equivalence Testing....Pages 59-65
Statistical Power and Sample Size....Pages 67-78
Interim Analyses....Pages 79-85
Multiple Statistical Inferences....Pages 87-96
Controlling the Risk of False Positive Clinical Trials....Pages 97-101
The Interpretation of the P-Values....Pages 103-115
Research Data Closer to Expectation than Compatible with Random Sampling....Pages 117-123
Principles of Linear Regression....Pages 125-140
Subgroup Analysis Using Multiple Linear Regression: Confounding, Interaction, Synergism....Pages 141-150
Curvilinear Regression....Pages 151-163
Logistic and Cox Regression, Problems with Regression Modeling, Markow Models....Pages 165-178
Regression Modeling for Improved Precision....Pages 179-185
Post-Hoc Analyses in Clinical Trials, a Case for Logistic Regression Analysis....Pages 187-191
Interaction Effects in Clinical Trials....Pages 193-204
Meta-Analysis....Pages 205-218
Crossover Studies with Continuous Variables: Power Analysis....Pages 219-228
Crossover Studies with Binary Responses....Pages 229-237
Cross-Over Trials Should Not be Used to Test Treatments with Different Chemical Class....Pages 239-248
Quality-Of-Life Assessments in Clinical Trials....Pages 249-259
Statistical Analysis of Genetic Data....Pages 261-269
Relationship Among Statistical Distributions....Pages 271-283
Testing Clinical Trials for Randomness....Pages 285-295
Clinical Data where Variability is more Important than Averages....Pages 297-306
Testing Reproducibility....Pages 307-317
Accuracy of Diagnostic Tests....Pages 319-328
Advanced Analysis of Variance....Pages 329-336
Statistics is No “Bloodless” Algebra....Pages 337-343
Bias Due to Conflicts of Interests, some Guidelines....Pages 345-351
Back Matter....Pages 353-366

✦ Subjects

Statistics for Life Sciences, Medicine, Health Sciences; Statistics, general