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Clinical trials : a practical approach /
This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical devel...
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Chichester :
Wiley,
2013.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Cover; Title Page; Contents; Preface; 1. Introduction: The Rationale of Clinical Trials; 1.1 Types of clinical trial; 1.2 Controlled clinical trials and the scientific method; 1.3 An example of a clinical trial for primary breast cancer; 2. The Historical Development of Clinical Trials; 2.1 Clinical trials before 1950; 2.2 Clinical trials since 1950; 2.3 Cancer chemotherapy in the United States; 2.4 Treatment of acute myocardial infarction; 2.5 The pharmaceutical industry; 3. Organization and Planning; 3.1 The protocol; 3.2 Administration, staff and finance; 3.3 Selection of patients
- 3.4 Treatment schedules 3.5 Evaluation of patient response; 4. The Justification for Randomized Controlled Trials; 4.1 Problems with uncontrolled trials; 4.2 Problems with historical controls; 4.3 Problems with concurrent non-randomized controls; 4.4 Is randomization feasible?; 5. Methods of Randomization; 5.1 Patient registration; 5.2 Preparing the randomization list; 5.3 Stratified randomization; 5.4 Unequal randomization; 6. Blinding and Placebos; 6.1 The justification for double-blind trials; 6.2 The conduct of double-blind trials; 6.3 When is blinding feasible?; 7. Ethical Issues
- 7.1 Medical progress and individual patient care 7.2 Informed patient consent; 8. Crossover Trials; 8.1 Within-patient comparisons; 8.2 The two-period crossover design; 8.3 The analysis and interpretation of crossover trials; 8.4 Multi-period crossover designs; 9. The Size of a Clinical Trial; 9.1 Statistical methods for determining trial size; 9.2 The realistic assessment of trial size; 9.3 The inadequacy of small trials; 9.4 Multi-centre trials; 9.5 The number of treatments and factorial designs; 10. Monitoring Trial Progress; 10.1 Reasons for monitoring; 10.2 Interim analyses
- 10.3 Repeated significance testing: group sequential designs 10.4 Continuous sequential designs; 11. Forms and Data Management; 11.1 Form design; 11.2 Data management; 11.3 The use of computers; 12. Protocol Deviations; 12.1 Ineligible patients; 12.2 Non-compliance and incomplete evaluation; 12.3 Inclusion of withdrawals in analysis; 13. Basic Principles of Statistical Analysis; 13.1 Describing the data; 13.2 Significance tests; 13.3 Estimation and confidence limits; 14. Further Aspects of Data Analysis; 14.1 Prognostic factors; 14.2 The analysis of survival data; 14.3 Multiplicity of data
- 15. Publication and Interpretation of Findings 15.1 Trial reports and their critical evaluation; 15.2 An excess of false-positives; 15.3 Combining evidence and overall strategy; References; Index