Randomized Clinical Trials Design, Practice and Reporting

ISBN-10: 0471498122
ISBN-13: 9780471498124
Edition: 2003
List price: $91.00 Buy it from $58.85
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Description: There have been numerous major advances in clinical trial methodology and this superb book will cover all developments in this important field. Written as a successor to the outstandingly successful book by Pocock 2Clinical Trials2, it will provide  More...

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Book details

List price: $91.00
Copyright year: 2003
Publisher: John Wiley & Sons, Incorporated
Publication date: 3/22/2010
Binding: Paperback
Pages: 374
Size: 6.75" wide x 9.75" long x 1.00" tall
Weight: 1.386
Language: English

There have been numerous major advances in clinical trial methodology and this superb book will cover all developments in this important field. Written as a successor to the outstandingly successful book by Pocock 2Clinical Trials2, it will provide up to date coverage of the topics covered in the original text whilst retaining the same authoritative and didactic approach. It will appeal to a wide readership including clinicians and data managers as well as medics and health care professionals who need to know the simple statistical issues in trials and statisticians who need to know about the medical and other non-statistical aspects of trials.

Preface
Introduction
Introduction
Some completed trials
Choice of design
Practical constraints
Influencing clinical practice
History
How trials arise
Ethical considerations
Regulatory requirements
Focus
Further reading
Design Features
Introduction
The research question
Patient selection
The consent process
Choice of interventions
Choice of design
Assigning the interventions
Making the assessments
Analysis and reporting
Technical details
Guidelines
Further reading
The Trial Protocol
Introduction
Protocol - abstract
Protocol - background
Protocol - research objectives
Protocol - design
Protocol - intervention details
Protocol - eligibility
Protocol - randomization
Protocol - assessment and data collection
Protocol - statistical considerations
Protocol - ethical issues
Protocol - organizational structure
Protocol - publication policy
Protocol - trial forms
Protocol - appendices
Regulatory requirements
Guidelines
Protocols
Measurement and Data Capture
Introduction
Measures and endpoints
Making the observations
Baseline measures
Types of measures
Data recording
Technical notes
Guidelines
Randomization
Introduction
Rationale
Mechanics
Application
Carrying out randomization
Documentation
Unacceptable methods
Software
Guidelines
Trial Initiation
Introduction
Trial organization
Data collection and processing
Data monitoring
Ethical and regulatory requirements
Launching the trial
Trial registries
Guidelines
Trial Conduct
Introduction
Regular feedback
Publicity
Data monitoring committees
Protocol modifications
Preparing the publication(s)
The next trial?
Protocols
Basics of Analysis
Introduction
Confidence intervals
Statistical tests
Examples of analysis
Other issues
Practice
Technical details
Trial Size
Introduction
Significance level and power
The fundamental equation
Specific situations
Practical considerations
Further topics
Other methods and software
Guideline
Reporting
Introduction
Publication guidelines
Responsibilities
Background
Methods
Findings
When things go wrong
Conclusions
Guidelines
Adaptations of the Basic Design
Introduction
Repeated measures
Cluster-randomized trials
Non-inferiority trials
Guidelines
Paired Designs
Cross-over trials
Split-mouth designs
Paired organs
More Than Two Interventions
Introduction
Unstructured comparisons
Comparisons with placebo (or standard)
Dose response designs
Factorial trials
Further Topics
Introduction
Adaptive approaches
Large simple trials
Bayesian methods
Zelen randomized-consent designs
Systematic overviews
Conclusion
Statistical Tables
Glossary
References
Index

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