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Introduction to randomized controlled clinical trials

Author: J N S Matthews
Publisher: Boca Raton, Fla. : CRC Press, ©2006.
Series: Texts in statistical science.
Edition/Format:   Print book : English : 2nd edView all editions and formats
Summary:
Evidence from randomized controlled clinical trials is widely accepted as the only sound basis for assessing the efficacy of new medical treatments. Statistical methods play a key role in all stages of these trials, including their justification, design, and analysis. This second edition of Introduction to Randomized Controlled Clinical Trials provides a concise presentation of the principles applied in this area.  Read more...
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Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: J N S Matthews
ISBN: 1584886242 9781584886242
OCLC Number: 64511342
Description: 283 pages : illustrations ; 24 cm.
Contents: WHAT IS A RANDOMIZED CONTROLLED TRIAL? --
Definition and Key Features --
Historical Context and the Nature of RCTS --
Structure and Justification of RCTs --
Exercises --
BIAS --
What is meant by bias in RCTs? --
Types of Bias --
Exercises --
HOW MANY PATIENTS DO I NEED? --
Criteria for Sample Size Calculations --
Hypothesis Tests --
Sample Size for a Normally Distributed Variable --
Sample Size for a Binary Variable --
General Remarks About Sample Size Calculations --
Exercises --
METHODS OF ALLOCATION --
Simple Randomization --
Random Permuted Blocks --
Biased Coin Designs and Urn Schemes --
Unequal Randomization --
Stratification --
Minimization --
Exercises --
ASSESSMENT, BLINDING AND PLACEBOS --
Double and Single Blindness --
Placebos --
Practical Considerations --
Exercises --
ANALYSIS OF RESULTS --
Example --
Use of Confidence Intervals --
Baselines: Uses and Abuses --
Analysis of Covariance --
Exercises --
FURTHER ANALYSIS: BINARY AND SURVIVAL DATA --
Binary Data: An Example and a Statistical Model --
Point Estimates and Hypothesis Tests --
Interval Estimates for the Binary Case --
Adjusting Binary Outcomes for Baseline Observations --
Survival Analysis --
Analyses Using Randomization Models --
Exercises --
MONITORING ACCUMULATING DATA --
Motivation and Problems with Repeated Analysis of Data --
Sequential and Group-Sequential Methods --
Other Approaches to Accumulating Data --
Data Monitoring Committees --
Exercises --
SUBGROUPS AND MULTIPLE OUTCOMES --
The Role of Sub-groups in Randomized Clinical Trials --
Methods for Comparing Sub-groups --
Methods of Selecting Sub-groups --
Qualitative Interactions --
Multiple outcomes --
Correction of P-values --
Some Alternative Methods for Multiple Outcomes --
Exercises --
PROTOCOLS AND PROTOCOL DEVIATIONS --
Protocols: Their Nature and Role --
Protocol Deviation --
Analysis by Intention-to-Treat --
Exercises. SOME SPECIAL DESIGNS: CROSSOVERS, EQUIVALENCE AND CLUSTERS --
Crossover Trials and Parallel Group Trials --
The AB/BA Design --
Analysis of AB/BA Design for Continuous Outcomes --
The Issue of Carryover --
Equivalence Trials --
Cluster Randomized Trials --
Exercises --
META-ANALYSES OF CLINICAL TRIALS --
What Are Meta-Analyses and Why Are They Needed? --
Some Methodology for Meta-Analysis --
Some Graphical Methods for Meta-Analysis --
Some General Issues in Meta-Analysis --
Exercises --
FURTHER READING --
SOLUTIONS TO EXERCISES --
REFERENCES.
Series Title: Texts in statistical science.
Responsibility: John N.S. Matthews.
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Abstract:

Focusing on the important role that statistical methods play in the analysis of the data collected as well as in the overall clinical trial process, this title provides an introduction to clinical  Read more...

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