Human Experimentation - Cleophas, Ton J.

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Biographie:
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 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 17 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 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 productionwill help them find the appropriate ways for answering their scientific questions. Three 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, 2015, all of them edited by Springer Heidelberg Germany....

Sommaire:
1 Placebos.- 1.1 Introduction.- 1.2 Ethical problems with placebo-controlled trials.- 1.3 Benefits of placebo-controlled trials.- 1.4 Technical problems with placebo-controlled trials.- 1.5 Conclusions.- 2 Fundamental Issues of Choosing the Right Type of Trials.- 2.1 Introduction.- 2.2 Ethical problems.- 2.3 Costs.- 2.4 Sample size.- 2.5 Between-subject variability of symptoms.- 2.6 Physical carryover effects.- 2.7 Time effects.- 2.8 Correlation between treatment modalities.- 2.9 Conclusions and examples.- 3 Lack of Real Science of Symptom-Based Care.- 3.1 Introduction.- 3.2 Methods.- 3.3 Study selection and data extraction.- 3.4 Data synthesis.- 3.5 Discussion.- 4 Carryover Effects in Clinical Research.- 4.1 Introduction.- 4.2 Dose response and dose titration studies.- 4.3 Studies with duplicate standard deviations.- 4.4 Open evaluations studies.- 4.5 Cross-over studies.- 4.6 Self-controlled Studies.- 4.7 Parallel-group studies.- 4.8 Studies with subjective variables.- 4.9 Discussion.- 5 Criticism of Negative Studies due to Negative Correlations.- 5.1 Introduction.- 5.2 Levels of correlation and sensitivity of testing.- 5.3 A simple test to check a posteriori whether the cause of a negative result is its level of correlation.- 5.4 Review of published crossover studies with a presumably negative correlation.- 5.5 Review of published crossover studies with a presumably positive correlation.- 5.6 Conclusions and recommendations.- 5.7 Conclusions.- 6 Between-Group Disparities in Drug Response.- 6.1 Introduction.- 6.2 Statistical model.- 6.3 Hypothetical examples, power analysis.- 6.4 Discussion.- 7 Specific Problems with Trials of Chronic Diseases.- 7.1 Introduction.- 7.2 Published clinical trials.- 7.3 Strengths and weaknesses of the two designs.- 7.4 Stage of study and the type of trial.- 7.5 More recent statistical papers on the subject.- 7.6 Conclusions.- 8 Clinical Trials with New Endpoints.- 8.1 Introduction.- 8.2 Subjective endpoints.- 8.3 New ethical priorities.- 8.4 Human touch rather than scientific rigor.- 8.5 Little emphasis on informed consent.- 8.6 Self-controlled rather than parallel-group designs.- 8.7 Conclusions.- 9 Linear Scale Assessment of Relevant Domains of Quality of Life - an example.- 9.1 Introduction.- 9.2 Patients and methods.- 9.3 Results.- 9.4 Discussion.- 10 Item Response Modeling and Quality of Life.- 10.1 Introduction.- 10.2 Methods.- 10.3 Results.- 10.4 Discussion.- 11 Is Selective Reporting of Well-Designed Research Unethical as Well as Unscientific ?.- 11.1 Introduction.- 11.2 Arguments against reporting negative studies.- 11.3 Arguments in favor of reporting negative studies.- 11.4 How progress of science was made in the past.- 11.5 Today the progress of science is faster, new rules are required.- 11.6 Suggestions for a balanced approach to the problem of selective reporting.- 11.7 Conclusions.- 12 Informed Consent Under Scrutiny, Suggestions for Improvement.- 12.1 Introduction.- 12.2 Ethical difficulties with the informed consent principle.- 12.3 Ethical difficulties with the informed consent process.- 12.4 Example of a flawed consent information form of a double-blind parallel-group study.- 12.5 Suggestions for improvement of the informed consent procedure.- 12.6 Conclusion.