Statistical issues in drug development:
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Chichester [u.a.]
Wiley
2007
|
| Ausgabe: | 2. ed. |
| Schriftenreihe: | Statistics in practice
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XIX, 498 S. graph. Darst. |
| ISBN: | 9780470018774 |
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| adam_text | STATISTICAL ISSUES IN DRUG DEVELOPMENT SECOND KDITION STEPHEN SENN
DEPARTMENT OF STATISTICS UNIVERSITY OF GLASGOW. UK 18 0 7 4 WILEY 2 O O
7 JOHN WILEY & SONS, LTD CONTENTS PREFACE TO THE SECOND EDITION XIII
PREFACE TO THE FIRST EDITION X VII ACKNOWLEDGEMENTS XX J 1 INTRODUCTION
1 1.1 DRUG DEVELOPMENT 1 1.2 THE ROLE OF STATISTICS IN DRUG DEVELOPMENT
2 1.3 THE OBJECT OF THIS BOOK 3 1.4 THE AUTHOR S KNOWLEDGE OF STATISTICS
IN DRUG DEVELOPMENT 4 1.5 THE READER AND HIS OR HER KNOWLEDGE OF
STATISTICS 4 1.6 HOW TO USE THE BOOK 5 REFERENCES 6 PART 1 FOUR VIEWS OF
STATISTICS IN DRUG DEVELOPMENT: HISTORICAL, METHODOLOGICAL, TECHNICAL
AND PROFESSIONAL 9 2 A BRIEF AND SUPERFICIAL HISTORY OF STATISTICS FOR
DRUG DEVELOPERS 11 2.1 INTRODUCTION 11 2.2 EARLY PROBABILISTS 12 2.3
FAMES BERNOULLI (1654-1705) 13 2.4 JOHN ARBUTHNOTT (1667-1753) 14 2.5
THE MATHEMATICS OF PROBABILITY IN THE LATE 17TH, THE 18TH AND EARLY 19TH
CENTURIES 14 2.6 THOMAS BAYES (1701-1761) 15 2.7
ADOLPHEQUETELET(1796-LH74) 16 2.8 FRANCIS GALTON (1822-1911) 16 2.9 KARL
PEARSON (1857-19 36) 17 2.10 STUDENT (1876-1937) 17 2.11 R.A. FISHER
(1890-1962) 17 2.12 MODERN MATHEMATICAL STATISTICS 18 2.13 MEDICAL
STATISTICS 19 2.14 STATISTICS IN CLINICAL TRIALS TODAY 20 2.15 THE
CURRENT DEBATE 21 2.16 A LIVING SCIENCE 21 2.17 FURTHER READING 2 5
REFERENCES 2 3 VIII CONTENTS DESIGN AND INTERPRETATION OF CLINICAL
TRIALS AS SEEN BY A STATISTICIAN 27 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9
3.10 3.11 3.12 3.13 PREFATORY WARNING INTRODUCTION DENNING EFFECTS
PRACTICAL PROBLEMS IN USING THE COUNTERFACTUAL ARGUMENT REGRESSION TO
THE MEAN CONTROL IN CLINICAL TRIALS RANDOMIZATION BLINDING USING
CONCOMITANT OBSERVATIONS MEASURING TREATMENT EFFECTS DATA GENERATION
MODELS IN CONCLUSION FURTHER READING REFERENCES 27 27 28 28 29 33 34 36
37 38 39 41 41 41 4 PROBABILITY, BAYES, F-VALUES, TESTS OF HYPOTHESES
AND CONFIDENCE INTERVALS **3 4.1 INTRODUCTION 43 4.2 AN EXAMPLE 44 4.3
ODDS AND SODS 44 4.4 THE BAYESIAN SOLUTION TO THE EXAMPLE 45 4.5 WHY
DON T WE REGULARLY USE THE BAYESIAN APPROACH IN CLINICAL TRIALS? 46 4.6
A FREQUENTIST APPROACH 47 4.7 HYPOTHESIS TESTING IN CONTROLLED CLINICAL
TRIALS 48 4.8 SIGNIFICANCE TESTS AND / -VALUES 49 4.9 CONFIDENCE
INTERVALS AND LIMITS AND CREDIBLE INTERVALS 50 4.10 SOME BAYESIAN
CRITICISM OF THE FREQUENTIST APPROACH 51 4.11 DECISION THEORY 51 4.12
CONCLUSION 52 4.13 FURTHER READING 52 REFERENCES 5 3 5 THE WORK OF THE
PHARMACEUTICAL STATISTICIAN 55 5.1 PREFATORY REMARKS 55 5.2 INTRODUCTION
56 5.3 IN THE BEGINNING 5 7 5.4 THE TRIAL PROTOCOL 57 5.5 THE
STATISTICIAN S ROLE IN PLANNING THE PROTOCOL 58 5.6 SAMPLE SIZE
DETERMINATION 59 5.7 OTHER IMPORTANT DESIGN ISSUES 60 5.8 RANDOMIZATION
60 5.9 DATA COLLECTION PREVIEW 61 5.10 PERFORMING THE TRIAL 61 5.11 DATA
ANALYSIS PREVIEW 61 5.12 ANALYSIS AND REPORTING 62 5.13 OTHER ACTIVITIES
6 3 CONTENTS I 5.14 STATISTICAL RESEARCH 63 5.15 FURTHER READING 64
REFERENCES 6 5 PART 2 STATISTICAL ISSUES: DEBATABLE AND CONTROVERSIAL
TOPICS IN DRUG DEVELOPMENT 67 6 ALLOCATING TREATMENTS TO PATIENTS IN
CLINICAL TRIALS 69 6.1 BACKGROUND 69 6.2 ISSUES 71 REFERENCES 8 7 6.A
TECHNICAL APPENDIX 88 7 BASELINES AND CORARIATE INFORMATION 95 7. 1
BACKGROUND 9 5 7.2 ISSUES 98 REFERENCES 108 7. A TECHNICAL APPENDIX 109
8 THE MEASUREMENT OF TREATMENT EFFECTS 113 8.1 BACKGROUND 113 8.2 ISSUES
114 REFERENCES 129 8.A TECHNICAL APPENDIX 1 30 9 DEMOGRAPHIC SUBGROUPS:
REPRESENTATION AND ANALYSIS 133 9.1 BACKGROUND 13 3 9.2 ISSUES 154
REFERENCES 144 9.A TECHNICAL APPENDIX 145 10 MULTIPLICITY 149 10.1
BACKGROUND 149 10.2 ISSUES 150 REFERENCES 161 10.A TECHNICAL APPENDIX
162 11 INTENTION TO TREAT, MISSING DATA AND RELATED MATTERS 165 11.1
BACKGROUND 165 11.2 ISSUES !* REFERENCES L X 11.A TECHNICAL APPENDIX
I K ) 12 ONE-SIDED AND TWO-SIDED TESTS AND OTHER ISSUES TO DO WITH
SIGNIFICANCE AND P-VALUES 1 ** 1 12.1 BACKGROUND 1*5 12.2 ISSUES L S 4
REFERENCES L 1 *- CONTENTS 16 17 18 19 20 21 13 DETERMINING THE SAMPLE
SIZE 195 13.1 BACKGROUND 19 5 13.2 ISSUES 198 REFERENCES 211 14
MULTICENTRE TRIALS 14.1 BACKGROUND 213 14.2 ISSUES 15 REFERENCES 14.A
TECHNICAL APPENDIX ACTIVE CONTROL EQUIVALENCE STUDIES 15.1 BACKGROUND
15.2 ISSUES REFERENCES 15.A TECHNICAL APPENDIX META- ANA LYSIS 16.1
BACKGROUND 16.2 ISSUES REFERENCES 16.A TECHNICAL APPENDIX CROSS-OVER
TRIALS 17.1 BACKGROUND 17.2 ISSUES REFERENCES N-OF-1 TRIALS 18.1
BACKGROUND 18.2 ISSUES REFERENCES SEQUENTIAL TRIALS 19.1 BACKGROUND 19.2
ISSUES REFERENCES DOSE-FINDING 20.1 BACKGROUND 20.2 ISSUES REFERENCES
CONCERNING PHARMACOKINETICS AND PHARMACODYNAMICS 21.1 BACKGROUND 21.2
ISSUES REFERENCES 230 231 235 235 237 247 249 251 251 253 268 270 273
273 275 284 287 287 289 293 295 295 302 313 317 317 319 334 337 337 343
358 CONTENTS XI 22. BIOEQUIVALENCE STUDIES 361 22.1 BACKGROUND 361 22.2
ISSUES 362 REFERENCES 3 79 23 SAFETY DATA, HARMS, DRUG MONITORING AND
PHARMACO-EPIDEMIOLOGY 383 23.1 BACKGROUND 383 23.2 ISSUES 388 REFERENCES
40 3 24 PHARMACO-ECONOMICS AND PORTFOLIO MANAGEMENT 405 24.1 BACKGROUND
405 24.2 ISSUES 407 REFERENCES 429 25 CONCERNING PHARMACOGENETICS,
PHARMACOGENOMICS AND RELATED MATTERS 433 25.1 BACKGROUND 433 25.2 ISSUES
437 REFERENCES 450 25.A TECHNICAL APPENDIX 451 GLOSSARY 453 INDEX 483
|
| adam_txt |
STATISTICAL ISSUES IN DRUG DEVELOPMENT SECOND KDITION STEPHEN SENN
DEPARTMENT OF STATISTICS UNIVERSITY OF GLASGOW. UK 18 0 7 4 WILEY 2 O O
7 JOHN WILEY & SONS, LTD CONTENTS PREFACE TO THE SECOND EDITION XIII
PREFACE TO THE FIRST EDITION X VII ACKNOWLEDGEMENTS XX J 1 INTRODUCTION
1 1.1 DRUG DEVELOPMENT 1 1.2 THE ROLE OF STATISTICS IN DRUG DEVELOPMENT
2 1.3 THE OBJECT OF THIS BOOK 3 1.4 THE AUTHOR'S KNOWLEDGE OF STATISTICS
IN DRUG DEVELOPMENT 4 1.5 THE READER AND HIS OR HER KNOWLEDGE OF
STATISTICS 4 1.6 HOW TO USE THE BOOK 5 REFERENCES 6 PART 1 FOUR VIEWS OF
STATISTICS IN DRUG DEVELOPMENT: HISTORICAL, METHODOLOGICAL, TECHNICAL
AND PROFESSIONAL 9 2 A BRIEF AND SUPERFICIAL HISTORY OF STATISTICS FOR
DRUG DEVELOPERS 11 2.1 INTRODUCTION 11 2.2 EARLY PROBABILISTS 12 2.3
FAMES BERNOULLI (1654-1705) 13 2.4 JOHN ARBUTHNOTT (1667-1753) 14 2.5
THE MATHEMATICS OF PROBABILITY IN THE LATE 17TH, THE 18TH AND EARLY 19TH
CENTURIES 14 2.6 THOMAS BAYES (1701-1761) 15 2.7
ADOLPHEQUETELET(1796-LH74) 16 2.8 FRANCIS GALTON (1822-1911) 16 2.9 KARL
PEARSON (1857-19 36) 17 2.10 'STUDENT' (1876-1937) 17 2.11 R.A. FISHER
(1890-1962) 17 2.12 MODERN MATHEMATICAL STATISTICS 18 2.13 MEDICAL
STATISTICS 19 2.14 STATISTICS IN CLINICAL TRIALS TODAY 20 2.15 THE
CURRENT DEBATE 21 2.16 A LIVING SCIENCE 21 2.17 FURTHER READING 2 5
REFERENCES 2 3 VIII CONTENTS DESIGN AND INTERPRETATION OF CLINICAL
TRIALS AS SEEN BY A STATISTICIAN 27 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9
3.10 3.11 3.12 3.13 PREFATORY WARNING INTRODUCTION DENNING EFFECTS
PRACTICAL PROBLEMS IN USING THE COUNTERFACTUAL ARGUMENT REGRESSION TO
THE MEAN CONTROL IN CLINICAL TRIALS RANDOMIZATION BLINDING USING
CONCOMITANT OBSERVATIONS MEASURING TREATMENT EFFECTS DATA GENERATION
MODELS IN CONCLUSION FURTHER READING REFERENCES 27 27 28 28 29 33 34 36
37 38 39 41 41 41 4 PROBABILITY, BAYES, F-VALUES, TESTS OF HYPOTHESES
AND CONFIDENCE INTERVALS **3 4.1 INTRODUCTION 43 4.2 AN EXAMPLE 44 4.3
ODDS AND SODS 44 4.4 THE BAYESIAN SOLUTION TO THE EXAMPLE 45 4.5 WHY
DON'T WE REGULARLY USE THE BAYESIAN APPROACH IN CLINICAL TRIALS? 46 4.6
A FREQUENTIST APPROACH 47 4.7 HYPOTHESIS TESTING IN CONTROLLED CLINICAL
TRIALS 48 4.8 SIGNIFICANCE TESTS AND /'-VALUES 49 4.9 CONFIDENCE
INTERVALS AND LIMITS AND CREDIBLE INTERVALS 50 4.10 SOME BAYESIAN
CRITICISM OF THE FREQUENTIST APPROACH 51 4.11 DECISION THEORY 51 4.12
CONCLUSION 52 4.13 FURTHER READING 52 REFERENCES 5 3 5 THE WORK OF THE
PHARMACEUTICAL STATISTICIAN 55 5.1 PREFATORY REMARKS 55 5.2 INTRODUCTION
56 5.3 IN THE BEGINNING 5 7 5.4 THE TRIAL PROTOCOL 57 5.5 THE
STATISTICIAN'S ROLE IN PLANNING THE PROTOCOL 58 5.6 SAMPLE SIZE
DETERMINATION 59 5.7 OTHER IMPORTANT DESIGN ISSUES 60 5.8 RANDOMIZATION
60 5.9 DATA COLLECTION PREVIEW 61 5.10 PERFORMING THE TRIAL 61 5.11 DATA
ANALYSIS PREVIEW 61 5.12 ANALYSIS AND REPORTING 62 5.13 OTHER ACTIVITIES
6 3 CONTENTS I\ 5.14 STATISTICAL RESEARCH 63 5.15 FURTHER READING 64
REFERENCES 6 5 PART 2 STATISTICAL ISSUES: DEBATABLE AND CONTROVERSIAL
TOPICS IN DRUG DEVELOPMENT 67 6 ALLOCATING TREATMENTS TO PATIENTS IN
CLINICAL TRIALS 69 6.1 BACKGROUND 69 6.2 ISSUES 71 REFERENCES 8 7 6.A
TECHNICAL APPENDIX 88 7 BASELINES AND CORARIATE INFORMATION 95 7. 1
BACKGROUND 9 5 7.2 ISSUES 98 REFERENCES 108 7. A TECHNICAL APPENDIX 109
8 THE MEASUREMENT OF TREATMENT EFFECTS 113 8.1 BACKGROUND 113 8.2 ISSUES
114 REFERENCES 129 8.A TECHNICAL APPENDIX 1 30 9 DEMOGRAPHIC SUBGROUPS:
REPRESENTATION AND ANALYSIS 133 9.1 BACKGROUND 13 3 9.2 ISSUES 154
REFERENCES 144 9.A TECHNICAL APPENDIX 145 10 MULTIPLICITY 149 10.1
BACKGROUND 149 10.2 ISSUES 150 REFERENCES 161 10.A TECHNICAL APPENDIX
162 11 INTENTION TO TREAT, MISSING DATA AND RELATED MATTERS 165 11.1
BACKGROUND 165 11.2 ISSUES !* " REFERENCES L" X 11.A TECHNICAL APPENDIX
I K ) 12 ONE-SIDED AND TWO-SIDED TESTS AND OTHER ISSUES TO DO WITH
SIGNIFICANCE AND P-VALUES 1 ** 1 12.1 BACKGROUND 1*5 12.2 ISSUES L S 4
REFERENCES L 1 *- CONTENTS 16 17 18 19 20 21 13 DETERMINING THE SAMPLE
SIZE 195 13.1 BACKGROUND 19 5 13.2 ISSUES 198 REFERENCES 211 14
MULTICENTRE TRIALS 14.1 BACKGROUND 213 14.2 ISSUES 15 REFERENCES 14.A
TECHNICAL APPENDIX ACTIVE CONTROL EQUIVALENCE STUDIES 15.1 BACKGROUND
15.2 ISSUES REFERENCES 15.A TECHNICAL APPENDIX META- ANA LYSIS 16.1
BACKGROUND 16.2 ISSUES REFERENCES 16.A TECHNICAL APPENDIX CROSS-OVER
TRIALS 17.1 BACKGROUND 17.2 ISSUES REFERENCES N-OF-1 TRIALS 18.1
BACKGROUND 18.2 ISSUES REFERENCES SEQUENTIAL TRIALS 19.1 BACKGROUND 19.2
ISSUES REFERENCES DOSE-FINDING 20.1 BACKGROUND 20.2 ISSUES REFERENCES
CONCERNING PHARMACOKINETICS AND PHARMACODYNAMICS 21.1 BACKGROUND 21.2
ISSUES REFERENCES 230 231 235 235 237 247 249 251 251 253 268 270 273
273 275 284 287 287 289 293 295 295 302 313 317 317 319 334 337 337 343
358 CONTENTS XI 22. BIOEQUIVALENCE STUDIES 361 22.1 BACKGROUND 361 22.2
ISSUES 362 REFERENCES 3 79 23 SAFETY DATA, HARMS, DRUG MONITORING AND
PHARMACO-EPIDEMIOLOGY 383 23.1 BACKGROUND 383 23.2 ISSUES 388 REFERENCES
40 3 24 PHARMACO-ECONOMICS AND PORTFOLIO MANAGEMENT 405 24.1 BACKGROUND
405 24.2 ISSUES 407 REFERENCES 429 25 CONCERNING PHARMACOGENETICS,
PHARMACOGENOMICS AND RELATED MATTERS 433 25.1 BACKGROUND 433 25.2 ISSUES
437 REFERENCES 450 25.A TECHNICAL APPENDIX 451 GLOSSARY 453 INDEX 483 |
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| index_date | 2024-07-02T18:53:51Z |
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| isbn | 9780470018774 |
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| spelling | Senn, Stephen Verfasser aut Statistical issues in drug development Stephen Senn 2. ed. Chichester [u.a.] Wiley 2007 XIX, 498 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Statistics in practice Médicaments - Développement - Méthodes statistiques Clinical Trials as Topic Drug Design Drug development Statistical methods Statistics as Topic methods GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016096521&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Senn, Stephen Statistical issues in drug development Médicaments - Développement - Méthodes statistiques Clinical Trials as Topic Drug Design Drug development Statistical methods Statistics as Topic methods |
| title | Statistical issues in drug development |
| title_auth | Statistical issues in drug development |
| title_exact_search | Statistical issues in drug development |
| title_exact_search_txtP | Statistical issues in drug development |
| title_full | Statistical issues in drug development Stephen Senn |
| title_fullStr | Statistical issues in drug development Stephen Senn |
| title_full_unstemmed | Statistical issues in drug development Stephen Senn |
| title_short | Statistical issues in drug development |
| title_sort | statistical issues in drug development |
| topic | Médicaments - Développement - Méthodes statistiques Clinical Trials as Topic Drug Design Drug development Statistical methods Statistics as Topic methods |
| topic_facet | Médicaments - Développement - Méthodes statistiques Clinical Trials as Topic Drug Design Drug development Statistical methods Statistics as Topic methods |
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