Clinical Trial Methodology

Karl E. Peace, Ding-Geng (Din) Chen

• Publisher: Chapman and Hall/CRC
• Year: 2010
• eBook ISBN: 9781040170700
• Topic: Mathematics
• Subtopic: Pharmacology
• Index: Mathematics

Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. Drawing from the authors' courses on the subject as well as the first author's more than 30 years wor

Table of contents

• Cover
• Half Title
• Chapman & Hall/CRC Biostatistics Series
• Title Page
• Copyright Page
• Dedication
• Contents
• Preface
• 1. Overview of Clinical Trial Methodology
• 2. Overview of the Drug Development Process and Regulation of Clinical Trials
• 3. Ethical Considerations in the Design and Conduct of Clinical Trials
• 4. Sample Size Considerations in Clinical Trials Pre-Market Approval
• 5. Sequential, Group Sequential, Stochastic Curtailment, and Adaptive Design Procedures in Clinical Trials
• 6. Biostatistical Aspects of the Protocol
• 7. The Statistical Analysis Plan
• 8. Pooling of Data from Multicenter Clinical Trials
• 9. Validity of Statistical Inference
• 10. Bioequivalence Clinical Trials
• 11. Dose and Frequency Determination from Phase II Clinical Trials in Stress Test–Induced Angina
• 12. Confirmation of Clinically Optimal Dosing in the Treatment of Duodenal Ulcers: A Phase III Dose Comparison Trial
• 13. Pivotal Proof-of-Efficacy Clinical Trials in the Prevention of NANSAID-Induced Gastric Ulceration
• 14. Clinical Trials in the Treatment of Alzheimer’s Disease Based upon Enrichment Designs
• 15. A Clinical Trial to Establish Reduction of CHD Risk
• 16. Pivotal Proof-of-Efficacy Clinical Trials in the Treatment of Panic Disorder
• 17. Combination Clinical Trials
• 18. Monitoring Clinical Trials for Adverse Events
• Index