Statistics Applied to Clinical Trials
4th Edition
Published on 16. December 2008
XXII, 562 pages
978-1-4020-9523-8 (ISBN)
Description
In clinical medicine appropriate statistics has become indispensable to evaluate treatment effects. Randomized controlled trials are currently the only trials that truly provide evidence-based medicine. Evidence based medicine has become crucial to optimal treatment of patients. We can define randomized controlled trials by using Christopher J. Bulpitt's definition "a carefully and ethically designed experiment which includes the provision of adequate and appropriate controls by a process of randomization, so that precisely framed questions can be answered". The answers given by randomized controlled trials constitute at present the way how patients should be clinically managed. In the setup of such randomized trial one of the most important issues is the statistical basis. The randomized trial will never work when the statistical grounds and analyses have not been clearly defined beforehand. All endpoints should be clearly defined in order to perform appropriate power calculations. Based on these power calculations the exact number of available patients can be calculated in order to have a sufficient quantity of individuals to have the predefined questions answered. Therefore, every clinical physician should be capable to understand the statistical basis of well performed clinical trials. It is therefore a great pleasure that Drs. T. J. Cleophas, A. H. Zwinderman, and T. F. Cleophas have published a book on statistical analysis of clinical trials. The book entitled "Statistics Applied to Clinical Trials" is clearly written and makes complex issues in statistical analysis transparant.
Reviews / Votes
From the reviews of the fourth edition:
"Readership: Students, physicians and investigators interested in statistical methods for clinical trials. This book was originally written for a course in medical statistics given in the EU sponsored program European Interuniversity Diploma of Pharmaceutical Medicine starting in the year 2000. . it has been expanded and updated in order to serve as a guide and reference-text to students, physicians and investigators." (Andreas Rosenblad, International Statistical Review, Vol. 77 (3), 2009)
"The book is written for students in health care and physicians and can be viewed as a guide and reference textbook. . an important contribution to the clinical trials and medical statistics community. . The book's main strength is its presentation, which deepens the knowledge and understanding of applications of statistical methods and analyses of clinical trials. . The many good motivating examples make the book a useful resource for instructors teaching introductory statistics courses. I enjoyed reading this book, and you will too." (Technometrics, Vol. 52 (2), May, 2010)
More details
Series
Edition
Fourth Edition 2009
Language
English
Place of publication
Dordrecht
Netherlands
Publishing group
Springer Netherland
Target group
Professional and scholarly
Illustrations
XXII, 562 p.
File size
9,73 MB
ISBN-13
978-1-4020-9523-8 (9781402095238)
DOI
10.1007/978-1-4020-9523-8
Schweitzer Classification
Other editions
Additional editions
Ton J. Cleophas | A.H. Zwinderman | Toine F. Cleophas
Statistics Applied to Clinical Trials
Book
04/2009
4th Edition
Springer
€80.20
Article exhausted; check for reprint
Previous edition
Ton J. Cleophas | A.H. Zwinderman | T.F. Cleophas
Statistics Applied to Clinical Trials
E-Book
04/2016
3rd Edition
Springer
€96.29
Available for download
Content
Hypotheses, Data, Stratification.- The Analysis Of Efficacy Data.- The Analysis of Safety Data.- Log Likelihood Ratio Tests For Safety Data Analysis.- Equivalence Testing.- Statistical Power And Sample Size.- Interim Analyses.- Controlling The Risk of False Positive Clinical Trials.- Multiple Statistical Inferences.- The Interpretation of The P-Values.- Research Data Closer To Expectation Than Compatible With Random Sampling.- Statistical Tables For Testing Data Closer To Expectation Than Compatible With Random Sampling.- Principles Of Linear Regression.- Subgroup Analysis Using Multiple Linear Regression: Confounding, Interaction, Synergism.- Curvilinear Regression.- Logistic and Cox Regression, Markow Models, Laplace Transformations.- Regression Modeling for Improved Precision.- Post-Hoc Analyses in Clinical Trials, a Case for Logistic Regression Analysis.- Confounding.- Interaction.- Meta-Analysis, Basic Approach.- Meta-Analysis, Review and Update of Methodologies.- Crossover Studies with Continuous Variables.- Crossover Studies with Binary Responses.- Cross-Over Trials Should not be Used to Test Treatments with Different Chemical Class.- Quality-of-Life Assessments in Clinical Trials.- Statistical Analysis of Genetic Data.- Relationship Among Statistical Distributions.- Testing Clinical Trials for Randomness.- Clinical Trials do not Use Random Samples Anymore.- Clinical Data Where Variability is More Important than Averages.- Testing Reproducibility.- Validating Qualitative Diagnostic Tests.- Uncertainty of Qualitative Diagnostic Tests.- Meta-Analysis of Diagnostic Accuracy.- Validating Quantitative Diagnostic Tests.- Summary of Validation Procedures for Diagnostic Tests.- Validating Surrogate Endpoints of Clinical Trials.- Methods for Repeated Measures Analysis.- Advanced Analysis of Variance, Random Effects and Mixed Effects Models.- Monte Carlo Methods.- Physicians' Daily Life and the Scientific Method.- Clinical Trials: Superiority-Testing.- Trend-Testing.-Odds Ratios and Multiple Regression Models, Why and How to Use Them.- Statistics is no "Bloodless" Algebra.- Bias Due to Conflicts of Interests, Some Guidelines.
