Randomized clinical trials: design application and reporting
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| Main Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Oxford [u.a.]
Wiley-Blackwell
2010
|
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XII, 361 S. graph. Darst. |
| ISBN: | 9780471498124 0471498122 |
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Record in the Search Index
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| adam_text | Titel: Randomized clinical trials
Autor: Machin, David
Jahr: 2010
Contents
Introduction
1.1 Introduction
1.2 Some completed trials
1.3 Choice of design
1.4 Practical constraints
1.5 Influencing clinical practice
1.6 History
1.7 How trials arise
1.8 Ethical considerations
1.9 Regulatory requirements
1.10 Focus
1.11 Further reading
Preface xi
l
2
9
14
15
16
18
19
20
20
21
2 Design Features 23
23
24
26
28
29
31
33
34
34
37
38
39
The Trial Protocol 41
3.1 Introduction 41
3.2 Protocol - abstract 43
3.3 Protocol - background 44
3.4 Protocol - research objectives 45
3.5 Protocol - design 48
3.6 Protocol - intervention details 49
2.1 Introduction
2.2 The research question
2.3 Patient selection
2.4 The consent process
2.5 Choice of interventions
2.6 Choice of design
2.7 Assigning the interventions
2.8 Making the assessments
2.9 Analysis and reporting
2.10 Technical details
2.11 Guidelines
2.12 Further reading
4.1 Introduction
4.2 Measures and endpoints
4.3 Making the observations
4.4 Baseline measures
4.5 Types of measures
4.6 Data recording
4.7 Technical notes
4.8 Guidelines
viii CONTENTS
3.7 Protocol - eligibility 52
3.8 Protocol - randomization 53
3.9 Protocol - assessment and data collection 56
3.10 Protocol - statistical considerations 58
3.11 Protocol - ethical issues 62
3.12 Protocol - organizational structure 64
3.13 Protocol - publication policy 65
3.14 Protocol - trial forms 66
3.15 Protocol - appendices 67
3.16 Regulatory requirements 68
3.17 Guidelines 69
3.18 Protocols 69
4 Measurement and Data Capture 71
71
72
79
82
82
84
92
93
5 Randomization 95
95
96
96
105
106
109
110
110
111
113
113
114
121
124
127
127
128
128
131
7.1 Introduction 131
7.2 Regular feedback 131
7.3 Publicity 134
7.4 Data monitoring committees 135
5.1 Introduction
5.2 Rationale
5.3 Mechanics
5.4 Application
5.5 Carrying out randomization
5.6 Documentation
5.7 Unacceptable methods
5.8 Software
5.9 Guidelines
Trial Initiation
6.1 Introduction
6.2 Trial organization
6.3 Data collection and processing
6.4 Data monitoring
6.5 Ethical and regulatory requirements
6.6 Launching the trial
6.7 Trial registries
6.8 Guidelines
Trial Conduct
8.1 Introduction
8.2 Confidence intervals
8.3 Statistical tests
8.4 Examples of analysis
8.5 Other issues
8.6 Practice
8.7 Technical details
CONTENTS ix
7.5 Protocol modifications 139
7.6 Preparing the publication(s) 140
7.7 The next trial? 143
7.8 Protocols 143
8 Basics of Analysis 145
145
146
147
148
171
175
175
9 Trial Size 179
179
180
182
184
190
194
196
197
199
199
200
204
206
206
217
226
227
227
11 Adaptations of the Basic Design 229
229
230
236
244
249
9.1 Introduction
9.2 Significance level and power
9.3 The fundamental equation
9.4 Specific situations
9.5 Practical considerations
9.6 Further topics
9.7 Other methods and software
9.8 Guideline
10 Reporting
10.1 Introduction
10.2 Publication guidelines
10.3 Responsibilities
10.4 Background
10.5 Methods
10.6 Findings
10.7 When things go wrong
10.8 Conclusions
10.9 Guidelines
11.1 Introduction
11.2 Repeated measures
11.3 Cluster-randomized trials
11.4 Non-inferiority trials
11.5 Guidelines
Paired Designs
12.1 Cross-over trials
12.2 Split-mouth designs
12.3 Paired organs
12 Paired Designs 251
251
264
269
x CONTENTS
13 More Than Two Interventions 275
275
275
279
284
289
297
297
298
306
310
315
318
322
323
329
337
349
13.1 Introduction
13.2 Unstructured comparisons
13.3 Comparisons with placebo (or standard)
13.4 Dose response designs
13.5 Factorial trials
14 Further Topics
14.1 Introduction
14.2 Adaptive approaches
14.3 Large simple trials
14.4 Bayesian methods
14.5 Zelen randomized-consent designs
14.6 Systematic overviews
14.7 Conclusion
Statistic al Tables
Glossary
References
Index
|
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| isbn | 9780471498124 0471498122 |
| language | English |
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| spelling | Machin, David 1939- Verfasser (DE-588)133115364 aut Randomized clinical trials design application and reporting David Machin ; Peter M. Fayers Oxford [u.a.] Wiley-Blackwell 2010 XII, 361 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Biomedical Research methods Clinical trials Clinical trials Statistical methods Data Interpretation, Statistical Randomized Controlled Trials as Topic methods Research Design Kontrollierte klinische Studie (DE-588)4202997-1 gnd rswk-swf Kontrollierte klinische Studie (DE-588)4202997-1 s DE-604 Fayers, Peter M. Verfasser aut HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=018625597&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Machin, David 1939- Fayers, Peter M. Randomized clinical trials design application and reporting Biomedical Research methods Clinical trials Clinical trials Statistical methods Data Interpretation, Statistical Randomized Controlled Trials as Topic methods Research Design Kontrollierte klinische Studie (DE-588)4202997-1 gnd |
| subject_GND | (DE-588)4202997-1 |
| title | Randomized clinical trials design application and reporting |
| title_auth | Randomized clinical trials design application and reporting |
| title_exact_search | Randomized clinical trials design application and reporting |
| title_full | Randomized clinical trials design application and reporting David Machin ; Peter M. Fayers |
| title_fullStr | Randomized clinical trials design application and reporting David Machin ; Peter M. Fayers |
| title_full_unstemmed | Randomized clinical trials design application and reporting David Machin ; Peter M. Fayers |
| title_short | Randomized clinical trials |
| title_sort | randomized clinical trials design application and reporting |
| title_sub | design application and reporting |
| topic | Biomedical Research methods Clinical trials Clinical trials Statistical methods Data Interpretation, Statistical Randomized Controlled Trials as Topic methods Research Design Kontrollierte klinische Studie (DE-588)4202997-1 gnd |
| topic_facet | Biomedical Research methods Clinical trials Clinical trials Statistical methods Data Interpretation, Statistical Randomized Controlled Trials as Topic methods Research Design Kontrollierte klinische Studie |
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