Statistical quality control in clinical trials:
Saved in:
| Main Author: | |
|---|---|
| Format: | Thesis Book |
| Language: | English |
| Published: |
Wien
WUV-Univ.-Verl.
1999
|
| Series: | Dissertationen der Universität Wien
60 |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | 145 S. graph. Darst. |
| ISBN: | 3851144899 |
Staff View
MARC
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Record in the Search Index
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|---|---|
| adam_text | Content 11
CONTENT
ACKNOWLEDGEMENT 7
ABSTRACT 9
PART I: STATISTICAL QUALITY CONTROL 17
1 Classical Statistical Quality Control 18
1.1 Historical Overview 18
1.2 Applications 21
2 Statistical Quality Control in Clinical Trials 24
2.1 Clinical Trials 24
2.2 Using statistical Quality Control in Clinical Trials 25
2.3 Special characteristics of clinical trials 27
2.4 Quality Characteristics 29
PART II: STATISTICAL METHODS 33
1 General 34
2 Data 34
2.1 Types of data 34
2.2 Units at Risk 35
3 The Role of Time 36
3.1 Calendar Time 36
3.2 Individual patient time 36
3.3 Notation 37
3.4 Individual observations Interval data 37
Content
38
4 Regression Analysis
4.1 Linear Regression
39
4.2 Logistic Regression
39
4.3 Poisson Regression
41
4.4 Notation
41
5 Breakpoint Analysis
42
5.1 Step Breakpoint Model
43
5.2 Slope Breakpoint Model
43
5.3 Likelihood ratio test
44
5.4F Test
44
6 One Step Ahead Forecast Error
44
6.1 Model
45
6.2 Standard deviation
A Q
6.3 Visualization
7 Shewhart Charts 52
7.1 Principles 52
7.2 Control charts for measurement data
7.3 Control charts for event data
8 Plots 57
8.1 Single Plots 5l
8.2 Recruitment Plot 57
PART III: ORIGIN OF INFORMATION 59
1 General 60
2 Requirements to the trials database scheme 60
Example for creating a database view 61
Content J__
3 Considering Quality Characteristics 62
3.1 General 62
3.2 Role of the time 62
3.3 An extract of the database scheme 63
3.4 Analysis overtime 67
3.5 Static analysis 71
PART IV: IMPLEMENTATION 73
1 Introduction 74
1.1 Basic Ideas 74
1.2 Using the macros 74
1.3 Macro features 75
1.4TheSAS System 76
2 Data management 77
2.1 General 77
2.2 Initialization data 77
2.3 Importing data 78
2.4 Selection of observations 79
2.5 Creating time variables and time intervals 80
2.6 Processing of events 81
2.7 Risk population 84
3 Description and syntax of the macros 85
3.1 General 85
3.2 Macros for initialization 87
3.3 Macros for data management 89
3.4 Macros for analysis 94
H Content
4 Examples 104
4.4 The data 104
4.5 Initialization 105
4.6 Data import 105
4.7 Data management 106
4.8 Shewhart Chart for time till data entry 107
4.9 One step ahead forecast error for a baseline value 108
4.10 Breakpoint regression for recruitment rate 109
4.11 Cumulative recruitment 111
4.12 Single Plots 112
CONCLUSION 114
APPENDIX 117
Appendix A Syntax of the macros (for Rel. 3.4) 118
A.I General 118
A.2 Macros for initialization 119
A.3 Macros for data management 120
A.4 Macros for analysis 121
Appendix B Dialogs of the Graphical User Interface 124
B.l Main Dialog 125
B.2 Initialization Information Dialog 126
B.3 Provide ODBC Connect Information Dialog 127
B.4 Import Data Dialog 128
B.5 Rename Variables Dialog 129
B.6 Merge Datasets Dialog 130
B.7 Create a new Variable Dialog 131
Content I5_
B.8 Create an Event Variable Dialog 132
B.9 Longitudinal Compatibility Dialog 133
B.10 Analysis Dialog 134
B.ll Breakpoint Analysis Dialog 135
B.I2 One step ahead forecast error Dialog 136
B.13 Shewhart Charts Dialog 137
B.14 Plot Analysis Dialog 138
INDEX OF TABLES 141
INDEX OF FIGURES 142
BIBLIOGRAPHY 143
|
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| spelling | Svolba, Gerhard Verfasser aut Statistical quality control in clinical trials Gerhard Svolba Wien WUV-Univ.-Verl. 1999 145 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Dissertationen der Universität Wien 60 Zugl.: Wien, Univ., Diss., 1998 Clinical trials gtt Statistik Clinical trials Quality control Statistical methods Klinisches Experiment (DE-588)4164223-5 gnd rswk-swf Arzneimittelprüfung (DE-588)4128030-1 gnd rswk-swf Klinische Prüfung (DE-588)4031192-2 gnd rswk-swf Qualitätssicherung (DE-588)4126457-5 gnd rswk-swf Qualitätskontrolle (DE-588)4047968-7 gnd rswk-swf Datenanalyse (DE-588)4123037-1 gnd rswk-swf Statistik (DE-588)4056995-0 gnd rswk-swf (DE-588)4113937-9 Hochschulschrift gnd-content Klinisches Experiment (DE-588)4164223-5 s Qualitätskontrolle (DE-588)4047968-7 s DE-604 Klinische Prüfung (DE-588)4031192-2 s Datenanalyse (DE-588)4123037-1 s Qualitätssicherung (DE-588)4126457-5 s Statistik (DE-588)4056995-0 s Arzneimittelprüfung (DE-588)4128030-1 s DE-188 Dissertationen der Universität Wien 60 (DE-604)BV010139301 60 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008703174&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Svolba, Gerhard Statistical quality control in clinical trials Dissertationen der Universität Wien Clinical trials gtt Statistik Clinical trials Quality control Statistical methods Klinisches Experiment (DE-588)4164223-5 gnd Arzneimittelprüfung (DE-588)4128030-1 gnd Klinische Prüfung (DE-588)4031192-2 gnd Qualitätssicherung (DE-588)4126457-5 gnd Qualitätskontrolle (DE-588)4047968-7 gnd Datenanalyse (DE-588)4123037-1 gnd Statistik (DE-588)4056995-0 gnd |
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| title | Statistical quality control in clinical trials |
| title_auth | Statistical quality control in clinical trials |
| title_exact_search | Statistical quality control in clinical trials |
| title_full | Statistical quality control in clinical trials Gerhard Svolba |
| title_fullStr | Statistical quality control in clinical trials Gerhard Svolba |
| title_full_unstemmed | Statistical quality control in clinical trials Gerhard Svolba |
| title_short | Statistical quality control in clinical trials |
| title_sort | statistical quality control in clinical trials |
| topic | Clinical trials gtt Statistik Clinical trials Quality control Statistical methods Klinisches Experiment (DE-588)4164223-5 gnd Arzneimittelprüfung (DE-588)4128030-1 gnd Klinische Prüfung (DE-588)4031192-2 gnd Qualitätssicherung (DE-588)4126457-5 gnd Qualitätskontrolle (DE-588)4047968-7 gnd Datenanalyse (DE-588)4123037-1 gnd Statistik (DE-588)4056995-0 gnd |
| topic_facet | Clinical trials Statistik Quality control Statistical methods Klinisches Experiment Arzneimittelprüfung Klinische Prüfung Qualitätssicherung Qualitätskontrolle Datenanalyse Hochschulschrift |
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