Analysis of Safety Data of Drug Trials

Preface



 

Chapter 1                                                                                                                                                                                                                                                                                                                                                                                                                                                                               

General Introduction 

 

The authors are well-qualified in their field. Professor Zwinderman is past-president of the International Society of Biostatistics (2012-2015), and Professor Cleophas is past-president of the American College of Angiology (2000-2002).
Professor Zwinderman is one of the Principle Investigators of the Academic Medical Center Amsterdam, and his research is concerned with developing statistical methods for new research designs in biomedical science, particularly integrating omics data, like genomics, proteomics, metabolomics, and analysis tools based on parallel computing and the use of cluster computers and grid computing.
Professor Cleophas is a member of the Academic Committee of the European College of Pharmaceutical Medicine, that provides, on behalf of 22 European Universities, the Master-ship trainings "Pharmaceutical Medicine" and "Medicines Development".
From their expertise they should be able to make adequate selections of modern methods for clinical data analysis for the benefit of physicians, students, and investigators. The authors have been working and publishing together for 18 years, and their research can be characterized as a continued effort to demonstrate that clinical data analysis is not mathematics but rather a discipline at the interface of biology and mathematics.
The authors as professors and teachers in statistics at universities in The Netherlands and France for the most part of their lives, are concerned, that their students find regression-analyses harder than any other methodology in statistics. This is serious, because almost all of the novel methodologies in current data mining and data analysis include elements of regression-analysis, and they do hope that the current production "Regression Analysis for Starters and 2nd Levelers" will be a helpful companion for the purpose. Five textbooks complementary to the current production and written by the same authors are
Statistics applied to clinical studies 5th edition, 2012,

"The analysis of safety data in drug trials, or in other drug studies, is an important topic. ... it is doubtful that this would make it a real book about safety analysis." (ISCB News, Vol. 68, 2019)