عنوان

Introduction to randomized controlled clinical trials /

1584886242

9781584886242

b754483

Introduction to randomized controlled clinical trials /

[Book]

John N.S. Matthews.

2nd ed.

Boca Raton, Fla. :

CRC Press,

©2006.

283 pages :

illustrations ;

24 cm.

Texts in statistical science

Includes bibliographical references (pages 269-272) and index.

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.

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.

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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. It details the concepts behind randomization and methods for designing and analyzing trials and also includes information on meta-analysis and specialized designs, such as cross-over trials, cluster-randomized designs, and equivalence studies. This latest edition features new and revised references, examples, exercises, and a new chapter dedicated to binary outcomes and survival analysis. It also presents numerous examples taken from the medical literature, contains exercises at the end of each chapter, and offers solutions in an appendix. The author uses Minitab and R software throughout the text for implementing the methods that are presented. Comprehensive and accessible, Introduction to Randomized Controlled Clinical Trials is well-suited for those familiar with elementary statistical ideas and methods who want to further their knowledge of the subject.

Clinical trials-- Statistical methods.

Randomized Controlled Trials as Topic.

Research Design.

Statistics as Topic.

Études cliniques-- Méthodes statistiques.

Clinical trials-- Statistical methods.

Clinical trials.

Klinisk prövning-- statistiska metoder.

Statistische methoden.

Matthews, J. N. S.

20201204141249.0

[Book]

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