Randomized Clinical Trials Design, Practice and Reporting

Name: Randomized Clinical Trials Design, Practice and Reporting
Price: 109.45 USD
Availability: InStock
ISBN: 9780471498124

ISBN-10: 0471498122

ISBN-13: 9780471498124

Edition: 2003

Authors: David Machin, Peter M. Fayers

List price: $94.75

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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 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.

Book details

List price: $94.75
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



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