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Introduction to randomized controlled clinical trials

Author: J N S Matthews
Publisher: Boca Raton, FL : Chapman & Hall/CRC, cop. 2006.
Series: Texts in statistical science.
Edition/Format:   Print book : English : 2nd edView all editions and formats

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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Document Type: Book
All Authors / Contributors: J N S Matthews
ISBN: 9781584886242 1584886242
OCLC Number: 492769094
Description: 1 volume (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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