Introduction to Randomized Controlled Clinical Trials

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, Introduction to Randomized Controlled Clinical Trials provides a concise and accessible introduction to clinical trials. This second edition features new and updated references, examples, exercises, and material on binary outcomes and survival analysis. It features numerous real examples taken from The Lancet, includes exercises at the end of the chapter, and offers solutions in an appendix. Ideal for advanced undergraduate and graduate students, the author uses Minitab and R software throughout the text for implementing the methods presented.

Zusatztext "?this book is very well presented and ? is extremely pleasant and enjoyable to read. Both the statistical concepts and medical examples are very well explained. I highly recommend this book as a course text and as an excellent reference book for anyone interested in clinical trials. A copy of it should certainly appear in every university library."-Journal of Applied Statistics! 2007"?a very welcome revision. The author has drawn upon his experiences to provide a valuable account of the important statistical underpinnings of the randomized clinical trial. ? written primarily for students of statistics ? highly desirable ? ideal for its intended audience." -Susan Todd! The University of Reading! UK "?The second edition builds upon the first by adding a chapter on binary and survival data and updating the chapter on balancing treatment allocations. Whether you might need to introduce a novice to the unique principles and pitfalls of clinical trials or remind an experienced statistician of their importance! this book would serve your purpose admirably. Moreover! as an experienced clinical trialist! I found it to be an excellent reminder of the statistical principles and concepts that underlie the day-to-day rules of our profession. ? Throughout! the author discusses principles! concepts and applications with a clarity that will be truly appreciated by those trained in mathematics. Each chapter focuses on a key challenge in the analysis of clinical trials and its associated statistical implications. ? Overall! the choice of chapter topics is comprehensive and well chosen. ? This text is definitely a handy reference-certainly worthwhile for a statistically conversant audience who are lacking in clinical trials experience. Such an audience will find this book educational and the author's concise style! an easy read. I would definitely recommend it for the bookshelf of anyone working in clinical trials."-Karen Kesler! Journal of Biopharmaceutical Statistics! Issue 5! 2007 Klappentext 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! Introduction to Randomized Controlled Clinical Trials provides a concise and accessible introduction to clinical trials. This second edition features new and updated references! examples! exercises! and material on binary outcomes and survival analysis. It features numerous real examples taken from The Lancet! includes exercises at the end of the chapter! and offers solutions in an appendix. Ideal for advanced undergraduate and graduate students! the author uses Minitab and R software throughout the text for implementing the methods presented. Zusammenfassung 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 trials. It features examples! exercises! and material on binary outcomes and survival analysis. It features various real examples taken from The Lancet. Inhaltsverzeichnis 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 FURT...

"this book is very well presented and is extremely pleasant and enjoyable to read. Both the statistical concepts and medical examples are very well explained. I highly recommend this book as a course text and as an excellent reference book for anyone interested in clinical trials. A copy of it should certainly appear in every university library."Journal of Applied Statistics, 2007 "a very welcome revision. The author has drawn upon his experiences to provide a valuable account of the important statistical underpinnings of the randomized clinical trial. written primarily for students of statistics highly desirable ideal for its intended audience." Susan Todd, The University of Reading, UK "The second edition builds upon the first by adding a chapter on binary and survival data and updating the chapter on balancing treatment allocations. Whether you might need to introduce a novice to the unique principles and pitfalls of clinical trials or remind an experienced statistician of their importance, this book would serve your purpose admirably. Moreover, as an experienced clinical trialist, I found it to be an excellent reminder of the statistical principles and concepts that underlie the day-to-day rules of our profession. Throughout, the author discusses principles, concepts and applications with a clarity that will be truly appreciated by those trained in mathematics. Each chapter focuses on a key challenge in the analysis of clinical trials and its associated statistical implications. Overall, the choice of chapter topics is comprehensive and well chosen. This text is definitely a handy reference-certainly worthwhile for a statistically conversant audience who are lacking in clinical trials experience. Such an audience will find this book educational and the author's concise style, an easy read. I would definitely recommend it for the bookshelf of anyone working in clinical trials."Karen Kesler, Journal of Biopharmaceutical Statistics, Issue 5, 2007

Autorentext

John N.S. Matthews

Klappentext

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.

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