Despite their effectiveness in the evaluation of new pharmacological compounds, controlled clinical trials are sometimes inadequate. Using data from the literature as well as from the author's own experience with clinical trials, Human Experimentation: Methodologic Issues Fundamental to Clinical Trials addresses such inadequacies and tries to provide solutions. This work is the first to thoroughly examine these unsolved inadequacies and problems with the design and the execution of clinical trials and, more importantly, to provide solutions for these problems. It is important for anyone who is…mehr
Despite their effectiveness in the evaluation of new pharmacological compounds, controlled clinical trials are sometimes inadequate. Using data from the literature as well as from the author's own experience with clinical trials, Human Experimentation: Methodologic Issues Fundamental to Clinical Trials addresses such inadequacies and tries to provide solutions. This work is the first to thoroughly examine these unsolved inadequacies and problems with the design and the execution of clinical trials and, more importantly, to provide solutions for these problems. It is important for anyone who is involved in clinical research: clinicians, pharmacists, biochemists, statisticians, nurses, sponsors, etc., and anyone who is involved in applying results of research to patients, i.e. physicians.
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.
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.
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