Overview
- Authors:
-
-
Ton J. Cleophas
-
European Interuniversity College of Pharmaceutical Medicine Lyon, France
Department Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands
-
Aeilko H. Zwinderman
-
European Interuniversity College of Pharmaceutical Medicine Lyon, France
Department Biostatistics and Epidemiology, Academic Medical Center Amsterdam, The Netherlands
-
Toine F. Cleophas
-
Technical University, Delft, The Netherlands
Access this book
Other ways to access
Table of contents (18 chapters)
-
Front Matter
Pages i-xiii
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 1-16
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 17-38
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 39-46
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 47-52
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 53-64
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 65-71
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 73-82
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 83-94
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 95-104
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 105-117
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 119-132
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 133-142
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 143-150
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 151-155
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 157-166
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 167-176
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 177-189
-
- Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas
Pages 191-197
-
Back Matter
Pages 199-210
About this book
In 1948 the first randomized controlled trial was published by the English Medical Research Council in the British Medical Journal. Until then, observations had been uncontrolled. Initially, trials frequently did not confirm hypotheses to be tested. This phenomenon was attributed to low sensitivity due to small samples, as well as inappropriate hypotheses based on biased prior trials. Additional flaws were recognized and subsequently were better accounted for: carryover effects due to insufficient washout from previous treatments, time effects due to external factors and the natural history of the condition under study, bias due to asymmetry between treatment groups, lack of sensitivity due to a negative correlation between treatment responses, etc. Such flaws, mainly of a technical nature, have been largely corrected and led to trials after 1970 being of significantly better quality than before. The past decade has focused, in addition to technical aspects, on the need for circumspection in planning and conducting of clinical trials. As a consequence, prior to approval, clinical trial protocols are now routinely scrutinized by different circumstantial bodies, including ethics committees, institutional and federal review boards, national and international scientific organizations, and monitoring committees charged with conducting interim analyses.
This book not only explains classical statistical analyses of clinical trials, but addresses relatively novel issues, including equivalence testing, interim analyses, sequential analyses, and meta-analyses, and provides a framework of the best statistical methods currently available for such purposes. The book is not only useful for investigators involved in the field of clinical trials, but also for all physicians who wish to better understand the data of trials as currently published.
