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El. knyga: Randomised Clinical Trials: Design, Practice and Reporting

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(Medical Research Council Cancer Trials Office, Cambridge), (Associate Professor, Dept of Epidemiology and Public Health, National University of Singapore, Singapore), (Medical Research Council Clinical Trials Unit, London, UK)
  • Formatas: EPUB+DRM
  • Išleidimo metai: 12-May-2021
  • Leidėjas: Wiley-Blackwell
  • Kalba: eng
  • ISBN-13: 9781119524670
Kitos knygos pagal šią temą:
Randomised Clinical Trials: Design, Practice and ReportingDidesnis paveikslėlis
  • Formatas: EPUB+DRM
  • Išleidimo metai: 12-May-2021
  • Leidėjas: Wiley-Blackwell
  • Kalba: eng
  • ISBN-13: 9781119524670
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Randomised Clinical Trials: Design, Practice and Reporting provides a detailed overview of the methodology for conducting clinical trials, including developing protocols, data capture, randomisation, analysis and reporting. Assuming no prior background, this user-friendly resource describes the statistical, regulatory, and practical components required for conducting randomised clinical trials. Numerous examples and case studies from industry, academia, and the research literature help readers understand each stage of the clinical trial process. 

This second edition contains extensively revised material throughout, including new chapters covering designs for repeated measures, non-inferiority, cluster and stepped wedge trials.  Other new chapters describe data and safety monitoring, biomarker studies, and feasibility studies.  Updated and expanded sections discuss situations where multiple organs, different body locations or competing risks are involved, subgroup analysis, and multiple outcomes.  Written by an author team with extensive experience in conducting clinical trials, this book: 

  • Provides comprehensive coverage of&;randomised clinical trials, ranging from basic to advanced  
  • Features several new chapters, updated case studies and examples, and references to changes in regulations 
  • Explains basic randomised trials, including the parallel two-group controlled trial with a single outcome measure 
  • Covers paired trial designs and trials with more than two interventions 
  • Includes a chapter on miscellaneous topics such as adaptive designs, large simple trials, Bayesian methods for very small trials, alpha-spending functions and the predictive probability test 

Randomised Clinical Trials is essential reading for clinicians, nurses, data managers, and medical statisticians involved in clinical trials, and for health practitioners responsible for direct patient care in a clinical trial setting. 

Preface xiii
Part I Basic Considerations 1(262)
1 Introduction
3(24)
1.1 Introduction
3(1)
1.2 Some completed trials
4(9)
1.3 Choice of design
13(5)
1.4 Practical constraints
18(2)
1.5 Influencing clinical practice
20(1)
1.6 History
20(2)
1.7 How do trials arise?
22(2)
1.8 Ethical considerations
24(1)
1.9 Regulatory requirements
24(1)
1.10 Focus
25(1)
1.11 Further reading
25(2)
2 Design Features
27(18)
2.1 Introduction
27(2)
2.2 The research question
29(1)
2.3 Patient selection
30(2)
2.4 The consent process
32(1)
2.5 Choice of interventions
33(2)
2.6 Choice of design
35(2)
2.7 Assigning the interventions
37(1)
2.8 Making the assessments
38(1)
2.9 Analysis and reporting
38(4)
2.10 Technical details
42(1)
2.11 Guidelines
43(1)
2.12 Further reading
44(1)
3 The Trial Protocol
45(32)
3.1 Introduction
45(2)
3.2 Abstract
47(2)
3.3 Background
49(1)
3.4 Research objectives
49(3)
3.5 Design
52(1)
3.6 Intervention details
53(3)
3.7 Eligibility
56(2)
3.8 Randomisation
58(3)
3.9 Assessment and data collection
61(2)
3.10 Statistical considerations
63(3)
3.11 Ethical issues
66(3)
3.12 Organisational structure
69(1)
3.13 Publication policy
69(1)
3.14 Trial forms
70(1)
3.15 Appendices
71(1)
3.16 Regulatory requirements
72(2)
3.17 Guidelines
74(1)
3.18 Protocols
74(3)
4 Measurement and Data Capture
77(26)
4.1 Introduction
77(1)
4.2 Types of measures
78(2)
4.3 Measures and endpoints
80(11)
4.4 Making the observations
91(1)
4.5 Baseline measures
92(1)
4.6 Data recording
93(8)
4.7 Technical notes
101(1)
4.8 Guidelines
101(2)
5 Randomisation
103(18)
5.1 Introduction
103(1)
5.2 Rationale
104(1)
5.3 Mechanics
104(9)
5.4 Application
113(2)
5.5 Carrying out randomisation
115(4)
5.6 Documentation
119(1)
5.7 Unacceptable methods
120(1)
5.8 Guidelines
120(1)
6 Trial Initiation
121(16)
6.1 Introduction
121(1)
6.2 Trial organisation
122(8)
6.3 Data collection and processing
130(2)
6.4 Internal data monitoring
132(1)
6.5 Ethical and regulatory requirements
133(1)
6.6 Launching the trial
134(1)
6.7 Trial registries
134(1)
6.8 Guidelines
135(2)
7 Trial Conduct and Completion
137(10)
7.1 Introduction
137(1)
7.2 Regular feedback
137(4)
7.3 Publicity
141(1)
7.4 Protocol modifications
142(1)
7.5 Preparing the publication(s)
142(3)
7.6 The next trial?
145(1)
7.7 Protocol
146(1)
8 Basics for Analysis
147(38)
8.1 Introduction
147(1)
8.2 The standard Normal distribution
148(1)
8.3 Confidence intervals
149(1)
8.4 Statistical tests
150(2)
8.5 Examples of analysis
152(17)
8.6 Regression methods
169(10)
8.7 Other issues
179(3)
8.8 Practice
182(1)
8.9 Technical details
183(2)
9 Trial Size
185(24)
9.1 Introduction
185(1)
9.2 Significance level and power
186(2)
9.3 The fundamental equation
188(2)
9.4 Specific situations
190(8)
9.5 Practical considerations
198(5)
9.6 Further topics
203(3)
9.7 Guideline
206(1)
9.8 Software
206(3)
10 Data and Safety Monitoring
209(20)
10.1 Introduction
209(2)
10.2 The DSMB
211(3)
10.3 Early reviews
214(5)
10.4 Interim reviews
219(9)
10.5 Protocols
228(1)
11 Reporting
229(34)
11.1 Introduction
229(1)
11.2 Publication
230(3)
11.3 Responsibilities
233(2)
11.4 Background
235(1)
11.5 Methods
236(12)
11.6 Findings
248(10)
11.7 When things go wrong
258(1)
11.8 Conclusions
259(1)
11.9 Guidelines
260(3)
Part II Adaptions of the Basic Design 263(152)
12 More Than Two Interventions
265(28)
12.1 Introduction
265(1)
12.2 Unstructured comparisons
266(4)
12.3 Comparisons with placebo (or standard)
270(5)
12.4 Dose-response designs
275(5)
12.5 Factorial. trials
280(9)
12.6 Complex structure comparisons
289(4)
13 Paired and Matched Designs
293(26)
13.1 Matched-pair trials
293(12)
13.2 Cross-over trials
305(6)
13.3 Split-mouth designs
311(6)
13.4 Guidelines
317(2)
14 Repeated Measures Design
319(38)
14.1 Introduction
319(3)
14.2 Simplified analysis
322(7)
14.3 Regression models
329(2)
14.4 Auto-correlation
331(3)
14.5 Accounting for auto-correlation
334(4)
14.6 The design effect (DE)
338(6)
14.7 Trial size
344(3)
14.8 Practicalities
347(3)
14.9 Reporting
350(4)
14.10 Matched organs receiving the same intervention
354(3)
15 Non-Inferiority and Equivalence Trials
357(18)
15.1 Introduction
357(1)
15.2 Non-inferiority
358(3)
15.3 Analysis
361(5)
15.4 Trial size
366(4)
15.5 Equivalence
370(3)
15.6 Reporting
373(1)
15.7 Practical Issues
373(1)
15.8 Guidelines
373(2)
16 Cluster Designs
375(16)
16.1 Design features
375(1)
16.2 Procedures
376(3)
16.3 Regression models
379(1)
16.4 Intra-class correlation
380(1)
16.5 Trial size
381(5)
16.6 Analysis
386(2)
16.7 Practicalities
388(1)
16.8 Reporting
388(1)
16.9 Further reading
389(2)
17 Stepped Wedge Designs
391(24)
17.1 Introduction
391(1)
17.2 Notation
392(4)
17.3 Basic structure
396(2)
17.4 Randomisation
398(1)
17.5 Cross-sectional design
398(10)
17.6 Closed cohort design
408(5)
17.7 Practicalities
413(2)
Part III Further Topics 415(68)
18 Genomic Targets
417(18)
18.1 Introduction
417(1)
18.2 Predictive markers
418(2)
18.3 Enrichment design
420(2)
18.4 Biomarker-Stratified Designs
422(9)
18.5 Adaptive threshold designs
431(4)
19 Feasibility and Pilot Studies
435(16)
19.1 Introduction
435(1)
19.2 Feasibility studies
436(1)
19.3 External-pilot studies
437(7)
19.4 Considerations across external-pilot and main trial
444(1)
19.5 Internal-pilot studies
445(2)
19.6 Other preliminary studies
447(2)
19.7 Reporting
449(2)
20 Further Topics
451(32)
20.1 Introduction
451(1)
20.2 Adaptive approaches
452(9)
20.3 Large simple trials
461(2)
20.4 Bayesian methods
463(4)
20.5 Interim analyses
467(5)
20.6 Zelen randomised consent designs
472(4)
20.7 Systematic overviews
476(7)
Statistical Tables 483(10)
Glossary 493(10)
References 503(20)
Index 523
David Machin, Leicester Cancer Research Group, University of Leicester, UK; and Medical Statistics Group, School of Health and Related Research, University of Sheffield, UK.

Peter M. Fayers, Institute of Applied Health, University of Aberdeen, UK.

Bee Choo Tai, Saw Swee Hock School of Public Health, National University of Singapore, and National University Health System, Singapore; and Yong Loo Lin School of Medicine, National University of Singapore and National University Health System, Singapore.
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