Human Experimentation: Methodologic Issues Fundamental to Clinical Trials

ISBN-13: 9780792358275 / Angielski / Miękka / 1999 / 120 str.

Ton J. Cleophas; T. J. Cleophas

Opis

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.

Spis treści

Foreword. Preface. 1. Placebos. 2. Fundamental Issues of Choosing the Right Type of Trial. 3. Lack of Real Science of Symptom-Based Care. 4. Carryover Effects in Clinical Research. 5. Criticism of Negative Studies Due to Negative Correlations. 6. Between-Group Disparities in Drug Response. 7. Specific Problems with Trials of Chronic Diseases. 8. Clinical Trials With New Endpoints. 9. Linear Scale Assessment of Relevant Domains of Quality of Life - an example. 10. Item Response Modeling and Quality of Life. 11. Is Selective Reporting of Well-Designed Research Unethical as Well as Unscientific? 12. Informed Consent Under Scrutiny, Suggestions for Improvement.