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本帖最后由 刘泽宏 于 2014-1-14 09:19 编辑
This book was written for those involved in clinical research and who may, from
time to time, need a guide to help demystify some of the most commonly used
statistical methods encountered in our profession.
All too often, I have heard medical directors of clinical research departments
express frustration at seemingly cryptic statistical methods sections of protocols
which they are responsible for approving.Other nonstatisticians, including medical
monitors, investigators, clinical project managers, medical writers and regulatory
personnel, often voice similar sentiment when it comes to statistics, despite the
profound reliance upon statistical methods in the success of the clinical program.
For these people, I offer this book (sans technical details) as a reference guide to
better understand statistical methods as applied to clinical investigation and the
conditions and assumptions under which they are applied.
For the clinical data analyst and statistician new to clinical applications, the
examples from a clinical trials setting may help in making the transition from other
statistical fields to that of clinical trials. The discussions of 'Least-Squares' means,
distinguishing features of the various SAS
®
types of sums-of-squares, and
relationships among various tests (such as the Chi-Square Test, the Cochran
Mantel-Haenszel Testand the Log-Rank Test) may help crystalize the analyst's
understanding of these methods. Analystswith no prior SAS experience should
benefit by the simplifed SAS programming statements provided with each example
as an introduction to SAS analyses.
This book may also aid the SAS programmer with limited statistical knowledge in
better grasping an overall picture of the clinical trials process. Many times
knowledge of the hypotheses being tested and appropriate interpretation of the
SAS output relative to those hypotheses will help the programmer become more
efficient in responding to the requests ofother clinical project team members.
Finally, the medical student will find the focused presentation on the specific
methods presented to be of value while proceeding through a first course in
biostatistics.
For all readers, my goal was to provide a unique approach to the description of
commonly used statistical methods by integrating both manual and computerized
solutions to a wide variety of examplestaken from clinical research. Those who
learn best by example should find this approach rewarding. I have found no other
book which demonstrates that the SAS output actually doeshave the same results
as the manual solution of a problem using the calculating formulas. So ever
reassuring this is for the student of clinical data analysis!
Preface to the Second Edition.........................................................................................................xi
Preface to the First Edition............................................................................................................xiii
Chapter 1 - Introduction & Basics
Chapter 2 – Topics inHypothesis Testing
Chapter 3 – The Data Set TRIAL
Chapter 4 – The One-Sample t-Test
Chapter 5 – The Two-Sample t-Test
Chapter 6 – One-Way ANOVA
Chapter 7 – Two-Way ANOVA
Chapter 8 – Repeated Measures Analysis
Chapter 9 – The Crossover Design
Chapter 10 – Linear Regression
Chapter 11 – Analysis of Covariance
Chapter 12 – The Wilcoxon Signed-Rank Test
Chapter 13 – The Wilcoxon Rank-Sum Test
Chapter 14 – The Kruskal-Wallis Test
Chapter 15 – The Binomial Test
Chapter 16 – The Chi-Square Test
Chapter 17 – Fisher’s Exact Test
Chapter 18 – McNemar’s Test
Chapter 19 – The Cochran-Mantel-Haenszel Test
Chapter 20 – Logistic Regression
Chapter 21 – The Log-Rank Test
Chapter 22 – The Cox Proportional Hazards Model
Chapter 23 – Exercises
Appendix A – Probability Tables
A.1 Probabilities of the Standard Normal Distribution.............................................................390
A.2 Critical Values of the Student t-Distribution.......................................................................391
A.3 Critical Values of the Chi-Square Distribution...................................................................392
Appendix B – Common Distributions Used in Statistical Inference
B.1 Notation....................................................................................................................................393
B.2 Properties.................................................................................................................................394
B.3 Results ......................................................................................................................................395
B.4 Distributional Shapes..............................................................................................................397
Appendix C – Basic ANOVA Concepts
C.1 Within- vs. Between-Group Variation..................................................................................399
C.2 Noise Reductionby Blocking ................................................................................................. 401
C.3 Least Squares Mean(LS-mean) ............................................................................................405
Appendix D – SS Types I, II, III, and IV Methods for an Unbalanced
Two-Way Layout
D.1 SS Types Computed by SAS ..................................................................................................409
D.2 How to Determine the Hypotheses Tested ...........................................................................411
D.3 Empty Cells..............................................................................................................................416
D.4 More Than Two Treatment Groups .....................................................................................417
D.5 Summary..................................................................................................................................419
Appendix E – Multiple Comparison Methods
E.1 Multiple Comparisons of Means ...........................................................................................421
E.2 Multiple Comparisons of Binomial Proportions..................................................................432
E.3 Summary..................................................................................................................................436
Appendix F – Data Transformations
F.1 Introduction.............................................................................................................................437
F.2 The Log Transformation........................................................................................................438
Appendix G – SAS Code for Exercises in Chapter 23....................................................441
References..............................................................................................................................................447
Index...................................................................................................................................................453
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发表于 2014-1-14 09:12:42
