Multiple testing problems in pharmaceutical statistics:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Boca Raton [u.a.]
CRC Press
2010
|
| Schriftenreihe: | Chapman & Hall/CRC biostatistics series
33 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | XVI, 304 S. graph. Darst. |
| ISBN: | 9781584889847 |
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| 245 | 1 | 0 | |a Multiple testing problems in pharmaceutical statistics |c ed. by Alex Dmitrienko ... |
| 264 | 1 | |a Boca Raton [u.a.] |b CRC Press |c 2010 | |
| 300 | |a XVI, 304 S. |b graph. Darst. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 490 | 1 | |a Chapman & Hall/CRC biostatistics series |v 33 | |
| 500 | |a Includes bibliographical references and index | ||
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| 650 | 4 | |a Clinical Trials as Topic | |
| 650 | 4 | |a Statistics as Topic | |
| 700 | 1 | |a Dmitrienko, Alex |e Sonstige |4 oth | |
| 830 | 0 | |a Chapman & Hall/CRC biostatistics series |v 33 |w (DE-604)BV023097394 |9 33 | |
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Datensatz im Suchindex
| _version_ | 1804140936931835904 |
|---|---|
| adam_text | CHAPMAN & HALL/CRC BIOSTATISTICS SERIES MULTIPLE TESTING PROBLEMS IN
PHARMACEUTICAL STATISTICS EDITED BY ALEX DMITRIENKO ELI LILLY AND
COMPANY INDIANAPOLIS, INDIANA, U.S.A. AJIT C. TAMHANE NORTHWESTERN
UNIVESITY EVANSTON, ILLINOIS, U.S.A. FRANK BRETZ NOVARTIS PHARMA AG
BASEL, SWITZERLAND HANNOVER MEDICAL SCHOOL GERMANY LTFI) CRC PRESS V^ J
TAYLOR & FRANCIS CROUP ^ **^ BOCA RATON LONDON NEW YORK CRC PRESS IS AN
IMPRINT OF THE TAYLOR & FRANCIS GROUP, AN INFORMA BUSINESS A CHAPMAN &
HALL BOOK CONTENTS PREFACE XI LIST OF CONTRIBUTORS XV 1 MULTIPLICITY
PROBLEMS IN CLINICAL TRIALS: A REGULATORY PERSPECTIVE 1 MOHAMMAD HUQUE
AND JOACHIM ROHMEL 1.1 INTRODUCTION 1 1.2 COMMON MULTIPLICITY PROBLEMS
IN CLINICAL TRIALS 3 1.2.1 CLINICAL WIN CRITERIA WITH PRIMARY ENDPOINTS
4 1.2.2 CONSISTENCY-ENSURED ANALYSIS OF MULTIPLE ENDPOINTS . 7 1.2.3
CO-PRIMARY ENDPOINTS 8 1.2.4 SECONDARY ENDPOINTS 11 1.2.5 DOSE-RESPONSE
AND DOSE-CONTROL COMPARISONS 12 1.2.6 SUBGROUP ANALYSES 14 1.2.7
COMBINATION DRUG TRIALS 16 1.2.8 THREE-ARM TRIALS WITH AN ACTIVE CONTROL
17 1.2.9 ADVANCED MULTIPLICITY PROBLEMS 20 1.3 REDUCING MULTIPLICITY IN
CLINICAL TRIALS 23 1.3.1 HIERARCHICAL TESTING 23 1.3.2 COMPOSITE
ENDPOINTS 25 1.4 MULTIPLICITY CONCERNS IN SPECIAL SITUATIONS 28 1.4.1
USE OF MULTIPLE SUBSETS OF PATIENT DATA 28 1.4.2 USE OF MULTIPLE
STATISTICAL METHODS 29 1.4.3 ANALYSIS OF COVARIANCE 29 1.5 MULTIPLICITY
IN THE ANALYSIS OF SAFETY ENDPOINTS 30 1.6 CONCLUDING REMARKS 32 2
MULTIPLE TESTING METHODOLOGY 35 ALEX DMITRIENKO, FRANK BRETZ, PETER H.
WESTFALL, JAMES TROENDLE, BRIAN L. WIENS, AJIT C. TAMHANE, AND JASON C.
HSU 2.1 INTRODUCTION 35 2.2 ERROR RATE DEFINITIONS 36 2.2.1
COMPARISONWISE AND FAMILY WISE ERROR RATES 36 2.2.2 GENERALIZED
FAMILYWISE ERROR RATE, FALSE DISCOVERY RATE AND FALSE DISCOVERY
PROPORTION 38 VI 2.2.3 ROLE OF TYPE II ERRORS 39 2.3 MULTIPLE TESTING
PRINCIPLES 40 2.3.1 UNION-INTERSECTION TESTING 40 2.3.2
INTERSECTION-UNION TESTING 41 2.3.3 CLOSURE PRINCIPLE 41 2.3.4
PROPERTIES OF CLOSED TESTING PROCEDURES 44 2.3.5 PARTITIONING PRINCIPLE
45 2.4 ADJUSTED SIGNIFICANCE LEVELS, P-VALUES AND CONFIDENCE INTERVALS
46 2.4.1 ADJUSTED SIGNIFICANCE LEVELS AND P- VALUES 46 2.4.2
SIMULTANEOUS CONFIDENCE INTERVALS 47 2.5 COMMON MULTIPLE TESTING
PROCEDURES 48 2.5.1 CLASSIFICATION OF MULTIPLE TESTING PROCEDURES 48
2.5.2 NOTATION 50 2.5.3 DOSE-FINDING TRIAL EXAMPLE 50 2.6 MULTIPLE
TESTING PROCEDURES BASED ON UNIVARIATE P-VALUES . . 52 2.6.1 BONFERRONI
PROCEDURE 52 2.6.2 HOLM PROCEDURE AND ITS EXTENSIONS 53 2.6.3
FIXED-SEQUENCE PROCEDURE 56 2.6.4 FALLBACK PROCEDURE 57 2.6.5
BONFERRONI-BASED CLOSED TESTING PROCEDURES 58 2.6.6 REVERSE
FIXED-SEQUENCE PROCEDURE 62 2.6.7 SIMES GLOBAL TEST 63 2.6.8 HOMMEL
PROCEDURE 65 2.6.9 HOCHBERG PROCEDURE 66 2.6.10 ADJUSTED P-VALUES 67
2.6.11 SIMULTANEOUS CONFIDENCE INTERVALS 70 2.7 PARAMETRIC MULTIPLE
TESTING PROCEDURES 73 2.7.1 SINGLE-STEP DUNNETT PROCEDURE 74 2.7.2
STEPWISE DUNNETT PROCEDURES 75 2.7.3 EXTENDED SHAFFER-ROYEN PROCEDURE 78
2.7.4 ADJUSTED JJ-VALUES AND SIMULTANEOUS CONFIDENCE INTERVALS 78 2.7.5
MULTIPLE COMPARISONS IN GENERAL LINEAR MODELS 81 2.8 RESAMPLING-BASED
MULTIPLE TESTING PROCEDURES 82 2.8.1 CLOSED RESAMPLING-BASED PROCEDURES
83 2.8.2 STEP-DOWN DUNNETT PROCEDURES BASED ON PARAMETRIC AND
NONPARAMETRIC RESAMPLING 85 2.8.3 STEP-DOWN RESAMPLING-BASED PROCEDURES
FOR MULTIVARI- ATE LINEAR MODELS 88 2.8.4 PERMUTATION-BASED PROCEDURES
90 2.9 SOFTWARE IMPLEMENTATION 94 2.9.1 MULTIPLE COMPARISON PROCEDURES
IN SAS 94 2.9.2 MULTIPLE COMPARISON PROCEDURES IN R 95 VLL MULTIPLE
TESTING IN DOSE-RESPONSE PROBLEMS 99 FRANK BRETZ, AJIT C. TAMHANE, AND
JOSE PINHEIRO 3.1 INTRODUCTION 99 3.2 DOSE-RESPONSE TREND TESTS 101
3.2.1 NOTATION 101 3.2.2 CONTRAST TESTS 102 3.2.3 MULTIPLE CONTRAST
TESTS FOR GENERAL LINEAR MODELS ... 104 3.2.4 THALIDOMIDE STUDY EXAMPLE
105 3.3 TARGET DOSE ESTIMATION USING MULTIPLE HYPOTHESIS TESTING . . 109
3.3.1 ESTIMATION OF THE MINIMUM EFFECTIVE DOSE ILL 3.3.2 ESTIMATION OF
THE MAXIMUM SAFE DOSE 115 3.4 POWER AND SAMPLE SIZE CALCULATION FOR
TARGET DOSE ESTIMATION 117 3.5 HYBRID APPROACHES COMBINING MULTIPLE
TESTING AND MODELING 118 3.5.1 MODELING TECHNIQUES 119 3.5.2 MCP-MOD: AN
INTEGRATED DOSE-FINDING APPROACH COM- BINING MULTIPLE COMPARISONS AND
MODELING 121 3.5.3 ASTHMA DOSE-FINDING TRIAL 125 ANALYSIS OF MULTIPLE
ENDPOINTS IN CLINICAL TRIALS 131 AJIT C. TAMHANE AND ALEX DMITRIENKO 4.1
INTRODUCTION 131 4.2 INFERENTIAL GOALS 133 4.2.1 AT-LEAST-ONE PROCEDURES
133 4.2.2 GLOBAL PROCEDURES 134 4.2.3 ALL-OR-NONE PROCEDURES 135 4.2.4
SUPERIORITY-NONINFERIORITY PROCEDURES 135 4.3 AT-LEAST-ONE PROCEDURES
136 4.3.1 PROCEDURES BASED ON UNIVARIATE P- VALUES 136 4.3.2 PARAMETRIC
AND RESAMPLING-BASED PROCEDURES 143 4.4 GLOBAL TESTING PROCEDURES 147
4.4.1 NORMAL THEORY MODEL 147 4.4.2 OLS AND GLS PROCEDURES 148 4.4.3
LIKELIHOOD RATIO AND OTHER PROCEDURES 153 4.4.4 PROCEDURES FOR
INDIVIDUAL ENDPOINTS 155 4.5 ALL-OR-NONE PROCEDURES 157 4.6
SUPERIORITY-NONINFERIORITY PROCEDURES 159 4.7 SOFTWARE IMPLEMENTATION
163 GATEKEEPING PROCEDURES IN CLINICAL TRIALS 165 ALEX DMITRIENKO AND
AJIT C. TAMHANE 5.1 INTRODUCTION 165 5.2 MOTIVATING EXAMPLES 166 5.2.1
CLINICAL TRIALS WITH SERIAL GATEKEEPERS 167 5.2.2 CLINICAL TRIALS WITH
PARALLEL GATEKEEPERS 168 5.2.3 CLINICAL TRIALS WITH TREE-STRUCTURED
GATEKEEPERS . . . . 170 VLLL 5.3 SERIAL GATEKEEPING PROCEDURES 171 5.3.1
GENERAL SERIAL GATEKEEPING FRAMEWORK 172 5.3.2 SERIAL GATEKEEPING
PROCEDURES WITH A SINGLE DECISION- MAKING BRANCH 173 5.3.3 SERIAL
GATEKEEPING PROCEDURES WITH MULTIPLE DECISION- MAKING BRANCHES 175 5.3.4
OTHER SERIAL GATEKEEPING PROCEDURES 176 5.4 PARALLEL GATEKEEPING
PROCEDURES 177 5.4.1 GENERAL PARALLEL GATEKEEPING FRAMEWORK 177 5.4.2
MULTISTAGE PARALLEL GATEKEEPING PROCEDURES 178 5.4.3 CARDIOVASCULAR
CLINICAL TRIAL EXAMPLE 182 5.5 TREE GATEKEEPING PROCEDURES 186 5.5.1
GENERAL TREE GATEKEEPING FRAMEWORK 186 5.5.2 COMBINATION-THERAPY
CLINICAL TRIAL EXAMPLE 188 5.6 SOFTWARE IMPLEMENTATION 189 ADAPTIVE
DESIGNS AND CONFIRMATORY HYPOTHESIS TESTING 193 WILLI MAURER, MICHAEL
BRANSON, AND MARTIN POSCH 6.1 INTRODUCTION 193 6.2 BASIC PRINCIPLES AND
METHODS OF ERROR RATE CONTROL 196 6.2.1 INTRODUCTION 196 6.2.2 CAUSES OF
MULTIPLICITY AND BIAS IN ADAPTIVE DESIGNS . . 196 6.2.3 REPEATED
HYPOTHESIS TESTING AT INTERIM ANALYSES IN GROUP SEQUENTIAL DESIGNS 197
6.2.4 ADAPTATION OF DESIGN FEATURES: SAMPLE SIZE 200 6.2.5 MULTIPLE
HYPOTHESIS SELECTION AND TESTING IN ADAPTIVE DESIGNS 204 6.3 PRINCIPLES
OF ADAPTIVE TESTING PROCEDURES 210 6.3.1 COMBINATION TEST PRINCIPLE 211
6.3.2 CONDITIONAL ERROR PRINCIPLE 212 6.4 ADAPTIVE MULTIPLE TESTING
PROCEDURES 214 6.4.1 ADAPTIVE CLOSED TESTS 214 6.4.2 ESTIMATION 218 6.5
CASE STUDIES 220 6.5.1 TREATMENT SELECTION DESIGN 220 6.5.2
SUBPOPULATION SELECTION DESIGN 229 6.6 DISCUSSION 235 DESIGN AND
ANALYSIS OF MICROARRAY EXPERIMENTS FOR PHARMACOGENOMICS 239 JASON C.
HSU, YOULAN RAO, YOONKYUNG LEE, JANE CHANG, KRISTIN BERGSTEINSDOTTIR,
MAGNUS KARL MAGNUSSON, TAO WANG, AND EIRIKUR STEINGRIMSSON 7. 1
POTENTIAL USES OF BIOMARKERS 239 7.2 CLINICAL USES OF GENETIC PROFILING
240 IX 7.3 TWO STAGES OF PHARMACOGENOMIC DEVELOPMENT 241 7.4
MULTIPLICITY IN PHARMACOGENOMICS 243 7.4.1 MULTIPLICITY OF GENES 244
7.4.2 MULTIPLICITY OF SUBGROUPS 248 7.5 DESIGNING PHARMACOGENOMIC
STUDIES 250 7.5.1 CONTROL FOR PLATFORM CHANGE USING EXTERNAL REFERENCE
SAMPLE 250 7.5.2 DESIGN TO DISCOVER GROUP DIFFERENCES 250 7.5.3
PERMUTATION TESTS MAY NOT CONTROL ERROR RATES 254 7.6 ANALYZING
MICROARRAY DATA BY MODELING 255 7.7 A PROOF OF CONCEPT EXPERIMENT 257
7.8 SOFTWARE IMPLEMENTATION 262 7.8.1 SAS PROCEDURES 262 7.8.2 R
FUNCTIONS 263 BIBLIOGRAPHY 265 INDEX 291
|
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| isbn | 9781584889847 |
| language | English |
| lccn | 2009040277 |
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| physical | XVI, 304 S. graph. Darst. |
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| spelling | Multiple testing problems in pharmaceutical statistics ed. by Alex Dmitrienko ... Boca Raton [u.a.] CRC Press 2010 XVI, 304 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Chapman & Hall/CRC biostatistics series 33 Includes bibliographical references and index Drugs Testing Statistical methods Clinical Trials as Topic Statistics as Topic Dmitrienko, Alex Sonstige oth Chapman & Hall/CRC biostatistics series 33 (DE-604)BV023097394 33 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=018803839&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Multiple testing problems in pharmaceutical statistics Chapman & Hall/CRC biostatistics series Drugs Testing Statistical methods Clinical Trials as Topic Statistics as Topic |
| title | Multiple testing problems in pharmaceutical statistics |
| title_auth | Multiple testing problems in pharmaceutical statistics |
| title_exact_search | Multiple testing problems in pharmaceutical statistics |
| title_full | Multiple testing problems in pharmaceutical statistics ed. by Alex Dmitrienko ... |
| title_fullStr | Multiple testing problems in pharmaceutical statistics ed. by Alex Dmitrienko ... |
| title_full_unstemmed | Multiple testing problems in pharmaceutical statistics ed. by Alex Dmitrienko ... |
| title_short | Multiple testing problems in pharmaceutical statistics |
| title_sort | multiple testing problems in pharmaceutical statistics |
| topic | Drugs Testing Statistical methods Clinical Trials as Topic Statistics as Topic |
| topic_facet | Drugs Testing Statistical methods Clinical Trials as Topic Statistics as Topic |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=018803839&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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