Statistical methods for clinical trials:
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
New York [u.a.]
Dekker
2001
|
| Schriftenreihe: | Biostatistics
8 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XVIII, 257 S. graph. Darst. |
| ISBN: | 0824704673 |
Internformat
MARC
| LEADER | 00000nam a2200000 cb4500 | ||
|---|---|---|---|
| 001 | BV013492614 | ||
| 003 | DE-604 | ||
| 005 | 20160202 | ||
| 007 | t | ||
| 008 | 001213s2001 d||| |||| 00||| eng d | ||
| 020 | |a 0824704673 |9 0-8247-0467-3 | ||
| 035 | |a (OCoLC)45121723 | ||
| 035 | |a (DE-599)BVBBV013492614 | ||
| 040 | |a DE-604 |b ger |e rakwb | ||
| 041 | 0 | |a eng | |
| 049 | |a DE-355 | ||
| 050 | 0 | |a R853.C55 | |
| 082 | 0 | |a 610/.7/27 |2 21 | |
| 100 | 1 | |a Norleans, Mark X. |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Statistical methods for clinical trials |c Mark X. Norleans |
| 264 | 1 | |a New York [u.a.] |b Dekker |c 2001 | |
| 300 | |a XVIII, 257 S. |b graph. Darst. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 490 | 1 | |a Biostatistics |v 8 | |
| 650 | 7 | |a Clinical trials |2 gtt | |
| 650 | 7 | |a Statistische methoden |2 gtt | |
| 650 | 4 | |a Études cliniques - Méthodes statistiques | |
| 650 | 4 | |a Biometry | |
| 650 | 4 | |a Clinical Trials as Topic | |
| 650 | 4 | |a Clinical trials |x Statistical methods | |
| 650 | 0 | 7 | |a Klinisches Experiment |0 (DE-588)4164223-5 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Statistik |0 (DE-588)4056995-0 |2 gnd |9 rswk-swf |
| 689 | 0 | 0 | |a Klinisches Experiment |0 (DE-588)4164223-5 |D s |
| 689 | 0 | 1 | |a Statistik |0 (DE-588)4056995-0 |D s |
| 689 | 0 | |5 DE-604 | |
| 830 | 0 | |a Biostatistics |v 8 |w (DE-604)BV013101415 |9 8 | |
| 856 | 4 | 2 | |m HBZ Datenaustausch |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009209003&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-009209003 | ||
Datensatz im Suchindex
| _version_ | 1804128282923237376 |
|---|---|
| adam_text | Contents
Series Introduction v
Preface vii
Chapter 1
The Logical Basis of Clinical Studies and Statistical Methods 1
1.1 The logical basis of clinical studies 1
1.2 The principle of statistical methods 3
1.3 Statistical methods for clinical studies 5
1.3.1 Data visualization and graphical data analysis 5
1.3.2 Comparison of summary measures 7
1.3.3 The analysis of variance 9
1.3.4 The analysis of dispersion 10
1.3.5 Permutation test 12
Chapter 2
Graphical Data Analysis 17
2.1 Cross display of data distribution 17
2.2 Categorical data and continuous data 19
2.3 Direct display of frequencies 19
2.3.1 Bar chart for categorical data 20
2.3.2 Picket fence plot for continuous data 21
2.3.3 Histogram for continuous data 24
2.4 Cumulative frequency plot for continuous data 24
2.5 Box plot for showing main body and outliers 27
2.6 Delta plot and tree plot for within patient contrasts 29
2.6.1 Delta plot for change from baseline 29
2.6.2 Tree plot for efficacy analysis 31
2.7 Scatter plot for profile analysis 33
xiii
xiv Contents
Chapter 3
Data Analysis with Summary Measures 37
3.1 Cross tabulation and display of summary measures 37
3.2 Number of patients for reliability and robustness 40
3.3 Mean and number of observations for categorical data 42
3.4 Frequently used summary measures 43
3.4.1 Mean and median 43
3.4.2 Standard deviation and average deviation 45
3.4.3 Standard error 46
Chapter 4
The Analysis of Variance 49
4.1 The method 49
4.2 Basic operations in the analysis of variance 52
4.2.1 Controlled versus uncontrolled factors 54
4.2.2 Grouping and curve fitting 55
4.2.3 Linear models as a technical language 57
4.3 Effects and their measurement 58
4.3.1 Type I measure 58
| 4.3.2 Type II measure 59
f 4.3.3 Type HI measure 61
4.3.4 Pros and cons and making choices 63
4.4 Presentation of analysis results 64
4.4.1 Graphical presentation 65
4.4.2 Marginal means or least squares means 66
4.4.3 The analysis of variance table 69
4.5 Limitations 70
4.6 Pairwise comparisons of multiple means 70
4.7 The analysis of variance for categorical data 72
Chapter 5
Frequently Debated Issues in the Analysis of
Clinical Trial Data 75
5.1 An overview 76
5.2 No center treatment interaction 77
5.3 The effects of center treatment interaction 79
5.4 The analysis of variance with covariates 81
Statistical Methods for Clinical Trials xv
5.4.1 Baseline measures 82
5.4.2 Statistical adjustment for the effects of covariates 83
5.5 Mean response profiles in a time course 86
5.6 Far from average individual response profiles 91
Chapter 6
Nonparametric Analysis, Analysis on a Complex Scale,
Analysis of Longitudinal Data, and Mixed Linear Models 93
6.1 An overview 94
6.2 Nonparametric analysis 94
6.3 The analysis of variance on a complex scale 95
6.4 Recent proposals for the analysis of longitudinal data 100
6.5 Analysis of longitudinal data with mixed linear models 105
Chapter 7
Survival Analysis 109
7.1 Survival data and summary measures 109
7.2 Cross tabulation of death and proj ected survival rates Ill
7.3 Kaplan Meier plot of projected survival rates 113
7.4 The analysis of variance on survival data 116
7.5 Analysis of variance with proportional hazard models 119
Chapter 8
The Design of Clinical Study Programs 123
8.1 An overview 123
8.2 Parallel and crossover setups 124
8.2.1 Parallel setups 124
8.2.2 Crossover setups 127
8.3 Randomization 130
8.4 Stratification 131
8.5 Blinding 133
8.6 Control 135
8.6.1 Longitudinal control 135
8.6.2 Parallel control 137
8.6.3 Placebo control versus active control 138
8.6.4 Pivotal control in clinical study program 140
8.7 Studies for dose efficacy safety relationship 141
xvi Contents
8.7.1 Confounding factors in evaluation of dosing 142
8.7.2 Dose escalating studies 144
8.7.3 Reflection on the traditional phases II and III paradigm 146
8.8 Studies for treatment substitution 147
8.8.1 Target range of disease control and study sensitivity 147
8.8.2 Patient heterogeneity and disease fluctuation 148
8.9 Determination of sample size 149
8.9.1 Sampling unit 150
8.9.2 Criteria for projecting sample size 150
8.9.3 Measurement of efficiency 155
Chapter 9
Integration of Clinical Studies 157
9.1 An overview 157
9.2 The principle of integration 159
9.2.1 Consistency and heterogeneity 159
9.2.2 Parameters to consider in planning integration studies 161
9.2.3 Source of information 163
9.3 The quality of clinical studies 165
9.3.1 The integrity of study design 165
9.3.2 The sufficiency of observations 167
9.3.3 Documentation in clinical study reports 168
9.4 Graphical analysis of integrated studies 171
9.4.1 Stratification by quality 171
9.4.2 Graphical arrays 173
9.5 The analysis of variance on pooled data 178
9.5.1 Common ground and appropriate stratification 178
9.5.2 An analysis of variance technique for compiling studies... 183
9.6 Some other techniques in meta analysis 184
9.6.1 The analysis of variance on summary measures 184
9.6.2 Effect size versus group specific measures 187
9.6.3 Variations among studies and the random effects 188
Chapter 10
The Fiction Behind the Current Statistics
and Its Consequences 191
10.1 An overview 191
Statistical Methods for Clinical Trials xvii
10.2 The fantasy of truth and the concept of errors 192
10.3 Assumption of distribution 193
10.4 P value 196
10.5 Confidence interval 197
10.6 Devastating impact on clinical research 198
10.6.1 Multiplicity 198
10.6.2 Statistical power and sample size 200
10.7 Statistical inference and testing for equivalence 201
10.8 The maximum likelihood technique 204
10.9 Clinical research and statistical methods 205
Chapter 11
Good Clinical Practice Guidelines 207
11.1 A brief history 207
11.2 An overview 208
11.3 Benefits of compliance with GCP guidelines 209
11.4 Investigators 210
11.4.1 Responsibilities 210
11.4.2 Necessary resources for an investigator site 212
11.5 Institutional review boards 214
11.6 Sponsors 215
11.6.1 Development of protocol 215
11.6.2 Handling of adverse events 218
Chapter 12
Data Management in Clinical Research 221
12.1 Perspective 221
12.2 Grading with clinically meaningful scales 222
12.2.1 Pain scores and visual analog scale 222
12.2.2 Clinically meaningful scales 224
12.3 Raw data and data representing judgment 225
12.4 Data management for physicians on a shoestring budget 226
12.5 Global clinical data management 229
Appendices 231
A Get results with SAS® 231
A.1 SAS ready data 231
xviii Contents
A.2 PROC GLM for the analysis of variance 232
A.3 The four types of sum of squares in PROC GLM 234
A.4 PROC MIXED for mean and individual profiles 237
A.5 PROC GENMOD for ANOVA on an arbitrary scale 239
B Linear models for the analysis of variance 241
B.I The maximum likelihood technique 242
B.2 General linear models 243
B.3 Generalized linear models on an arbitrary scale 244
C Analysis of variance for integrating a series of studies 245
D The results of 18 trials on P blockade 248
References 249
Index 251
|
| any_adam_object | 1 |
| author | Norleans, Mark X. |
| author_facet | Norleans, Mark X. |
| author_role | aut |
| author_sort | Norleans, Mark X. |
| author_variant | m x n mx mxn |
| building | Verbundindex |
| bvnumber | BV013492614 |
| callnumber-first | R - Medicine |
| callnumber-label | R853 |
| callnumber-raw | R853.C55 |
| callnumber-search | R853.C55 |
| callnumber-sort | R 3853 C55 |
| callnumber-subject | R - General Medicine |
| ctrlnum | (OCoLC)45121723 (DE-599)BVBBV013492614 |
| dewey-full | 610/.7/27 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 610 - Medicine and health |
| dewey-raw | 610/.7/27 |
| dewey-search | 610/.7/27 |
| dewey-sort | 3610 17 227 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| format | Book |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01626nam a2200445 cb4500</leader><controlfield tag="001">BV013492614</controlfield><controlfield tag="003">DE-604</controlfield><controlfield tag="005">20160202 </controlfield><controlfield tag="007">t</controlfield><controlfield tag="008">001213s2001 d||| |||| 00||| eng d</controlfield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">0824704673</subfield><subfield code="9">0-8247-0467-3</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)45121723</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)BVBBV013492614</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-604</subfield><subfield code="b">ger</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1="0" ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">DE-355</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">R853.C55</subfield></datafield><datafield tag="082" ind1="0" ind2=" "><subfield code="a">610/.7/27</subfield><subfield code="2">21</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Norleans, Mark X.</subfield><subfield code="e">Verfasser</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Statistical methods for clinical trials</subfield><subfield code="c">Mark X. Norleans</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">New York [u.a.]</subfield><subfield code="b">Dekker</subfield><subfield code="c">2001</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">XVIII, 257 S.</subfield><subfield code="b">graph. Darst.</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="b">n</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="b">nc</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="490" ind1="1" ind2=" "><subfield code="a">Biostatistics</subfield><subfield code="v">8</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Clinical trials</subfield><subfield code="2">gtt</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Statistische methoden</subfield><subfield code="2">gtt</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Études cliniques - Méthodes statistiques</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Biometry</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Clinical Trials as Topic</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Clinical trials</subfield><subfield code="x">Statistical methods</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Klinisches Experiment</subfield><subfield code="0">(DE-588)4164223-5</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Statistik</subfield><subfield code="0">(DE-588)4056995-0</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="689" ind1="0" ind2="0"><subfield code="a">Klinisches Experiment</subfield><subfield code="0">(DE-588)4164223-5</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2="1"><subfield code="a">Statistik</subfield><subfield code="0">(DE-588)4056995-0</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2=" "><subfield code="5">DE-604</subfield></datafield><datafield tag="830" ind1=" " ind2="0"><subfield code="a">Biostatistics</subfield><subfield code="v">8</subfield><subfield code="w">(DE-604)BV013101415</subfield><subfield code="9">8</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="m">HBZ Datenaustausch</subfield><subfield code="q">application/pdf</subfield><subfield code="u">http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009209003&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA</subfield><subfield code="3">Inhaltsverzeichnis</subfield></datafield><datafield tag="999" ind1=" " ind2=" "><subfield code="a">oai:aleph.bib-bvb.de:BVB01-009209003</subfield></datafield></record></collection> |
| id | DE-604.BV013492614 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T18:46:46Z |
| institution | BVB |
| isbn | 0824704673 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-009209003 |
| oclc_num | 45121723 |
| open_access_boolean | |
| owner | DE-355 DE-BY-UBR |
| owner_facet | DE-355 DE-BY-UBR |
| physical | XVIII, 257 S. graph. Darst. |
| publishDate | 2001 |
| publishDateSearch | 2001 |
| publishDateSort | 2001 |
| publisher | Dekker |
| record_format | marc |
| series | Biostatistics |
| series2 | Biostatistics |
| spelling | Norleans, Mark X. Verfasser aut Statistical methods for clinical trials Mark X. Norleans New York [u.a.] Dekker 2001 XVIII, 257 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Biostatistics 8 Clinical trials gtt Statistische methoden gtt Études cliniques - Méthodes statistiques Biometry Clinical Trials as Topic Clinical trials Statistical methods Klinisches Experiment (DE-588)4164223-5 gnd rswk-swf Statistik (DE-588)4056995-0 gnd rswk-swf Klinisches Experiment (DE-588)4164223-5 s Statistik (DE-588)4056995-0 s DE-604 Biostatistics 8 (DE-604)BV013101415 8 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009209003&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Norleans, Mark X. Statistical methods for clinical trials Biostatistics Clinical trials gtt Statistische methoden gtt Études cliniques - Méthodes statistiques Biometry Clinical Trials as Topic Clinical trials Statistical methods Klinisches Experiment (DE-588)4164223-5 gnd Statistik (DE-588)4056995-0 gnd |
| subject_GND | (DE-588)4164223-5 (DE-588)4056995-0 |
| title | Statistical methods for clinical trials |
| title_auth | Statistical methods for clinical trials |
| title_exact_search | Statistical methods for clinical trials |
| title_full | Statistical methods for clinical trials Mark X. Norleans |
| title_fullStr | Statistical methods for clinical trials Mark X. Norleans |
| title_full_unstemmed | Statistical methods for clinical trials Mark X. Norleans |
| title_short | Statistical methods for clinical trials |
| title_sort | statistical methods for clinical trials |
| topic | Clinical trials gtt Statistische methoden gtt Études cliniques - Méthodes statistiques Biometry Clinical Trials as Topic Clinical trials Statistical methods Klinisches Experiment (DE-588)4164223-5 gnd Statistik (DE-588)4056995-0 gnd |
| topic_facet | Clinical trials Statistische methoden Études cliniques - Méthodes statistiques Biometry Clinical Trials as Topic Clinical trials Statistical methods Klinisches Experiment Statistik |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009209003&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV013101415 |
| work_keys_str_mv | AT norleansmarkx statisticalmethodsforclinicaltrials |