Statistics Applied to Clinical Trials: Self-Assessment Book

Naslovnica
Springer Science & Business Media, 6. pro 2012. - Broj stranica: 226
The authors have taught statistics and given statistics workshops in France and the Netherlands for almost 4 years by now. Their material, mainly on power point, consists of 12 lectures that have been continuously changed and improved by interaction with various audiences. For the purpose of the current book simple English text has been added to the formulas and figures, and the power points sheets have been rewritten in the format given by Kluwer Academic Publishers. Cartoons have been removed, since this is not so relevant for the transmission of thought through a written text, and at the end of each lecture (chapter) a representative number of questions and exercises for self-assessment have been added. At the end of the book detailed answers to the questions and exercises per lecture are given. The book has been produced with the same size and frontpage as the textbook "Statistics Applied To Clinical Trials" by the same authors and edited by same publishers ( 2nd Edition, DordrechtiBostonlLondon, 2002), and can be applied together with the current self-assessment book or separately. The current self-assessment book is different from the texbook, because it focuses on the most important aspects rather than trying to be complete. So, it does not deal with all of the subjects assessed in the texbook. Instead, it repeats on and on the principle things that are needed for every analysis, and it gives many examples that are further explained by arrows in the figures.
 

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INTRODUCTION TO THE STATISTICAL ANALYSIS OF CLINICAL TRIALS CONTINUOUS DATA ANALYSIS 1 Scientific rigor 2 Two types o...
1
Historical controls 4 Factorial designs 5 Biology is full of variations
2
Summarize the data
3
Two Gaussian curves 8 Human brain
4
Hypothesis
8
Nullhypothesis
9
Alpha the Type I error
10
Ttable
11
Sequential trials
129
Efficacy Z
130
Conclusion
131
MULTIPLE TESTING 1 Two situations
133
51
134
graphical display
135
Two strategies
136
Alternatives
137

Reject the nullhypothesis
12
Negative trial
13
Borderline result
14
Testing two means
15
Testing paired samples
16
Unpaired testing of paired samples
17
Positive and negative correlations
18
Unpaired analysis of variance ANOVA
19
Paired analysis of variance ANOVA
20
Nonparametric testing for skewed data
21
Paired nonparametric test MannWhitney
22
Unpaired nonparametric test Wilcoxon rank sum
23
Summary
24
Exercises to chapter 1
34
Alpha beta 1beta
41
CHAPTER 2EQUIVALENCE TESTING V xiii XV 1 1 2 222 2 2 3 4 4 5 6 7 8 9 9 10 12 14 15 15 17 18 19 20 22 22
44
Use of Ttable to find power one more example
47
Conclusions
53
McNemars test for paired yesno observations
65
PROPORTIONAL DATA ANALYSIS PART II
72
2x2 table
85
Sample size calculation
87
Discussed so far
88
1 sample two measurements
89
A negative study equivalent study why so? 2 Summarize the data 3 Two Gaussian curves 4 Nullhypothesis
90
McNemars test
91
Cochrans test
92
special techniques
93
KaplanMeier curve
94
definition
95
3333
96
example
97
logrank test
98
software
99
Questions to chapter 5
100
METAANALYSIS 1 Review of the past
103
What is a metaanalysis
104
Proportions standard errors of proportions odds odds ratios
105
How to calculate 95 confidence intervals of an odds ratio
106
Another summary of metaanalyses helpful to cardiologists for
107
Important matters need few words
108
Negative study 6 Equivalence testing 27 28 29
109
Strict inclusion criteria
110
second pitfall heterogeneity
111
How to test heterogeneity calculate and pool odds ratios of various studies
112
What to do in case of heterogeneity
113
third pitfall lack of robustness
115
Criticizms of metaanalyses
116
Example of published metaanalysis
117
47
118
Additional exercises to chapter 6
121
looking at the data before closure
123
50
124
Changing inclusion criteria
125
Dangers random high
126
Correction for increasing typeI error rate
127
Some rules
128
results
138
another graphical display
139
Multiple testing
140
Correction
141
graphical display
142
graphical display
143
Conclusion
144
25
147
Paired data plotted first
148
Correlation coefficient
149
SPSS Statistical software to analyze data from paragraph 1 stool data
150
Three columns of paired observations instead of two
151
Another example of multiple linear regression model
152
Multicollinearity testing of the above example
153
Conclusions
154
SUBGROUP ANALYSIS USING REGRESSION MODELING 1 Subgroup questions 159
158
Different regression models
160
Linkfunctions
161
Assumptions of the linear regression model
162
Logistic and Cox regression model
163
PROPORTIONAL DATA ANALYSIS PART I
164
An example where the Cox model does not fit
165
example
166
example of a regression model
167
graphical illustration
168
Confounding
169
warning
170
example
171
graphical illustration
172
Questions to chapter 10
173
RELATIONSHIP AMONG STATISTICAL DISTRIBUTIONS 1 Variables to assess clinical data
175
Creating a chisquare distribution
176
1 x 2 table
177
2 x 2 table
178
Why not x for continuous data
179
What is the advantage of a x²test compared to a z test normal test
180
Examples
181
More examples how to calculate 95 confidence intervals of an odds
182
heterogeneity of trials in a metaanalysis
184
Limitations of statistical tests as discussed and conclusions
185
Questions and exercises to Chapter 11
186
STATISTICS IS NOT BLOODLESS ALGEBRA 1 Biological processes are full of variations
189
Statistical principles improve quality of trial
190
Statistics is not like algebra and requires biological thinking and just a bit
191
Statistics for support rather than illumination?
192
Limitations of statistics
193
BIAS DUE TO CONFLICTS OF INTERESTS SOME GUIDELINES 1 Introduction 197
196
Need for circumspection recognized
198
Flawed procedures jeopardizing current clinical trials
199
The good news
200
References
202
STATISTICAL TABLES
203
ANSWERS TO QUESTIONS AND EXERCISES
211
INDEX 221
220
Standard deviation of proportion
224
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