Understanding Clinical Data Analysis

Chapter 1

Randomness

Basis of All Scientific Methods

 

Chapter 2

Randomized and Observational Research

Writing Protocols, Making Study Data Files

 

Chapter 3

Randomized Clinical Trials, Designs

Questionable Use of Placebos and Lack of Placebos, Stepped Wedge and  Adaptive Designs

 

Chapter 4

Randomized Clinical Trials, Analysis Sets, Statistical Analysis, Reporting Issues

Principal Features of Statistical Analyses, the Cochrane Risk-of-Bias-Tool

 

Chapter 5

Discrete Data Analysis, Failure Time Data Analysis

Better Assessments of Biological and Pharmaceutical Agents              

 

Chapter 6

Quantitative Data Analysis

Modeling for False Positive Findings, Using Median Absolute Deviations

 

Chapter 7

Subgroup AnalysisEuropean Medicines Agency's and American Food Drug Administration's Directives 



 

Chapter 8

Interim Analysis

Alpha Spending Function Approach 



Chapter 9

Multiplicity Analysis

Gate Keeping Strategies and Closure Principles

 

Chapter 10

Medical Statistics, a Discipline at the Interface of Biology and Mathematics

Equating Subjective Feelings with Probabilities, and Providing Quality Criteria for Diagnostic Tests

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). From their expertise they should be able to choose the best-help-there-is for making difficult issues understandable, that is real data examples from the global literature rather than hypothetical examples.

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 philosophy, 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 convinced, that the scientific method of statistical reasoning and hypothesis testing is little used by physicians and other health workers, and they hope, that the current production will help them find the appropriate ways for answering their scientific questions. Four textbooks complementary to the current production and written by the same authors are Statistics applied to clinical studies 5th edition, 2012, Machine learning in medicine a complete overview, 2015, SPSS for starters and 2nd levelers 2nd edition, 2015, Clinical Data Analysis on a Pocket Calculator 2nd edition, 2016, all of them edited by Springer Heidelberg Germany.