Clinical trials : a practical approach
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| Format: | E-Book Buch |
| Sprache: | Englisch |
| Veröffentlicht: |
Chichester
Wiley
1983
John Wiley & Sons, Incorporated |
| Ausgabe: | 1 |
| Schlagworte: | |
| ISBN: | 0471901555, 9780471901556 |
| Online-Zugang: | Volltext |
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Inhaltsangabe:
- 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