Statistics applied to clinical trials:
Saved in:
| Main Author: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Dordrecht [u.a.]
Kluwer Acad. Publ.
2002
|
| Edition: | 2. ed. |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Item Description: | Includes bibliographical references and index |
| Physical Description: | IX, 210 S. graph. Darst. |
| ISBN: | 1402005695 1402005709 |
Staff View
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| 245 | 1 | 0 | |a Statistics applied to clinical trials |c by Ton J. Cleophas, Aeilko H. Zwinderman, and Toine F. Cleophas |
| 250 | |a 2. ed. | ||
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| 300 | |a IX, 210 S. |b graph. Darst. | ||
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| adam_text | TABLE OF CONTENTS
PREFACE xi
FOREWORD xiii
CHAPTER 1 / HYPOTHESES, DATA, STRATIFICATION
1. General considerations 1
2. Two main hypotheses in drug trials: efficacy and safety 2
3. Different types of data: continuous data 3
4. Different types of data: proportions, percentages and contingency tables 8
5. Different types of data: correlation coefficient 11
6. Stratification issues 13
7. Randomized versus historical controls 14
8. Factorial designs 15
9. References 16
CHAPTER 2 / THE ANALYSIS OF EFFICACY DATA OF DRUG TRIALS
1. Overview 17
2. The principle of testing statistical significance 18
3. Unpaired T Test 21
4. Null hypothesis testing of 3 or more unpaired samples 23
5. Three methods to test statistically a paired sample 24
6. Null hypothesis testing of 3 or more paired samples 28
7. Paired data with a negative correlation 29
8. Rank testing 35
9. References 38
CHAPTER 3 / THE ANALYSIS OF SAFETY DATA OF DRUG TRIALS
1. Introduction, summary display 39
2. Four methods to analyze two unpaired proportions 40
3. Chi square to analyze more than two unpaired proportions 42
4. McNemar s test for paired proportions 43
5. Survival analysis 44
6. Conclusions 46
CHAPTER 4 / EQUIVALENCE TESTING
1. Introduction 47
2. Overview of possibilities with equivalence testing 49
3. Equivalence testing, a new gold standard? 51
4. Validity of equivalence trials 51
VI
CHAPTER 5 / STATISTICAL POWER AND SAMPLE SIZE
1. What is statistical power 53
2. Emphasis on statistical power rather than null hypothesis testing 54
3. Power computations 56
4. Example of power computation using the T Table 57
5. Calculation of required sample size, rationale 59
6. Calculations of required sample size, methods 59
7. Testing not only superiority but also inferiority of a new treatment (type III 62
error)
8. References 64
CHAPTER 6 / INTERIM ANALYSES
1. Introduction 65
2 .Monitoring 65
3. Interim analysis 66
4. Group sequential design of interim analysis 69
5. Continuous sequential statistical techniques 69
6. Conclusions 71
7. References 71
CHAPTER 7 / MULTIPLE STATISTICAL INFERENCES
1. Introduction 73
2. Multiple comparisons 73
3. Primary and secondary variables 78
4. Conclusions 81
5. References 81
CHAPTER 8 / PRINCIPLES OF LINEAR REGRESSION
1 Introduction 83
2 More on paired observations 84
3 Using statistical software for simple linear regression 87
4 Multiple linear regression 89
5 Another real data example of multiple linear regression 93
6 Conclusions 94
CHAPTER 9 / SUBGROUP ANALYSIS USING MULTIPLE LINEAR
REGRESSION: CONFOUNDING, INTERACTION, SYNERGISM
1 Introduction 95
2 Example 95
3 Model 96
4 (I.) Increased precision of efficacy 98
5(11.) Confounding 99
6 (III.) Interaction and synergism 100
7 Estimation, and hypothesis testing 101
8 Goodness of fit 102
Vll
9. Selection procedures 103
10. Conclusions 103
11. References 104
CHAPTER 10 / CURVILINEAR REGRESSION
1. Summary 105
2. An example: curvilinear regression analysis of ambulatory blood pressure
measurements 106
3. Methods, statistical model 106
4. Results 108
5. Discussion 115
6. References 116
CHAPTER 11 / META ANALYSIS
1. Introduction 119
2. Examples 120
3. Clearly defined hypotheses 121
4. Thorough search of trials 121
5. Strict inclusion criteria 122
6. Uniform data analysis 122
7. Discussion, where are we now? 131
8. References 132
CHAPTER 12 / CROSSOVER STUDIES WITH CONTINUOUS VARIABLES:
POWER ANALYSIS
1. Summary 133
2. Introduction 133
3. Mathematical model 134
4. Hypothesis testing 135
5. Statistical power of testing 137
6. Conclusions 140
7. References 141
CHAPTER 13 / CROSSOVER STUDIES WITH BINARY RESPONSES
1. Summary 143
2. Introduction 143
3. Assessment of carryover and treatment effect 144
4. Statistical model for testing treatment and carryover effects 145
5. Results 146
6. Examples 148
7. Discussion 149
8. References 150
viii
CHAPTER 14 / POST HOC ANALYSIS IN CLINICAL TRIALS, A CASE FOR
LOGISTIC REGRESSION ANALYSIS
1. Multivariate methods 151
2. Examples 151
3. Logistic regression equation 154
4. Conclusions 155
5. References 155
CHAPTER 15 / QUALITY OF LIFE ASSESSMENTS IN CLINICAL TRIALS
1. Summary 157
2. Introduction 158
3. Some terminology 158
4. Defining QOL in a subjective or objective way 160
5. The patients opinion is an important independent contributor to QOL 160
6. Lack of sensitivity of QOL assessments 162
7. Odds ratio analysis of effects of patient characteristics on QOL data 162
provides increased precision
8. Discussion 165
9. References 166
CHAPTER 16 / STATISTICS FOR THE ANALYSIS OF GENETIC DATA
1. Introduction 167
2. Some terminology 168
3. Genetics, genomics, proteonomics, data mining 170
4. Genomics 171
5. Conclusions 175
6. References 175
CHAPTER 17 / RELATIONSHIP AMONG STATISTICAL DISTRIBUTIONS
1. Summary 177
2. Introduction 177
3. Variances 178
4. The normal distribution 179
5. Null hypothesis testing with the normal or the t distribution 181
6. Relationship between the normal distribution and chi square distribution, 183
null hypothesis testing with the chi square distribution
7. Examples of data where variance is more important than mean 185
8. Chi square can be used for multiple samples of data 186
9. Conclusions 188
10. References 189
1A
CHAPTER 18 / STATISTICS IS NOT BLOODLESS ALGEBRA
1. Introduction 191
2. Statistics is fun because it proves your hypothesis was right 191
3. Statistical principles can help to improve the quality of the trial 192
4. Statistics can provide worthwhile extras to your research 192
5. Statistics is not like algebra bloodless 193
6. Statistics can turn art into science 194
7. Statistics for support rather than illumination? 194
8. Statistics can help the clinician to better understand limitations and 195
benefits of current research
9. Limitations of statistics 195
10. Conclusions 196
11. References 197
APPENDIX 199
INDEX 207
|
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| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615/.1/0727 |
| dewey-search | 615/.1/0727 |
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| dewey-tens | 610 - Medicine and health |
| discipline | Mathematik Medizin |
| edition | 2. ed. |
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| indexdate | 2024-07-09T19:03:13Z |
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| isbn | 1402005695 1402005709 |
| language | English |
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| spelling | Cleophas, Ton J. 1947- Verfasser (DE-588)1069424161 aut Statistics applied to clinical trials by Ton J. Cleophas, Aeilko H. Zwinderman, and Toine F. Cleophas 2. ed. Dordrecht [u.a.] Kluwer Acad. Publ. 2002 IX, 210 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Includes bibliographical references and index Clinical trials gtt Médicaments - Essais cliniques - Méthodes statistiques Statistiek gtt Études cliniques - Méthodes statistiques Statistik Clinical Trials as Topic methods Clinical trials Statistical methods Data Interpretation, Statistical Drugs Testing Statistical methods Medizinische Statistik (DE-588)4127563-9 gnd rswk-swf Medizinische Statistik (DE-588)4127563-9 s DE-604 Zwinderman, Aeilko H. 1960- Sonstige (DE-588)108382225X oth Cleophas, Toine F. Sonstige oth HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009886492&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Cleophas, Ton J. 1947- Statistics applied to clinical trials Clinical trials gtt Médicaments - Essais cliniques - Méthodes statistiques Statistiek gtt Études cliniques - Méthodes statistiques Statistik Clinical Trials as Topic methods Clinical trials Statistical methods Data Interpretation, Statistical Drugs Testing Statistical methods Medizinische Statistik (DE-588)4127563-9 gnd |
| subject_GND | (DE-588)4127563-9 |
| title | Statistics applied to clinical trials |
| title_auth | Statistics applied to clinical trials |
| title_exact_search | Statistics applied to clinical trials |
| title_full | Statistics applied to clinical trials by Ton J. Cleophas, Aeilko H. Zwinderman, and Toine F. Cleophas |
| title_fullStr | Statistics applied to clinical trials by Ton J. Cleophas, Aeilko H. Zwinderman, and Toine F. Cleophas |
| title_full_unstemmed | Statistics applied to clinical trials by Ton J. Cleophas, Aeilko H. Zwinderman, and Toine F. Cleophas |
| title_short | Statistics applied to clinical trials |
| title_sort | statistics applied to clinical trials |
| topic | Clinical trials gtt Médicaments - Essais cliniques - Méthodes statistiques Statistiek gtt Études cliniques - Méthodes statistiques Statistik Clinical Trials as Topic methods Clinical trials Statistical methods Data Interpretation, Statistical Drugs Testing Statistical methods Medizinische Statistik (DE-588)4127563-9 gnd |
| topic_facet | Clinical trials Médicaments - Essais cliniques - Méthodes statistiques Statistiek Études cliniques - Méthodes statistiques Statistik Clinical Trials as Topic methods Clinical trials Statistical methods Data Interpretation, Statistical Drugs Testing Statistical methods Medizinische Statistik |
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