Clinical Trial Methodology

Drawing from the authors' courses on the subject as well as Peace's more than 30 years working in the pharmaceutical industry, "Clinical Trial Methodology" emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research.

Overview of Clinical Trial Methodology. Overview of the Drug Development Process and Regulation of Clinical Trials. Ethical Considerations in the Design and Conduct of Clinical Trials. Sample Size Considerations in Clinical Trials Pre-Market Approval. Sequential, Group Sequential, Stochastic Curtailment, and Adaptive Design Procedures in Clinical Trials. Biostatistical Aspects of the Protocol. The Statistical Analysis Plan. Pooling of Data from Multicenter Clinical Trials. Validity of Statistical Inference. Bioequivalence Clinical Trials. Dose and Frequency Determination from Phase II Clinical Trials in Stress Test-Induced Angina. Confirmation of Clinically Optimal Dosing in the Treatment of Duodenal Ulcers: A Phase III Dose Comparison Trial. Pivotal Proof-of-Efficacy Clinical Trials in the Prevention of NANSAID-Induced Gastric Ulceration. Clinical Trials in the Treatment of Alzheimer's Disease Based upon Enrichment Designs. A Clinical Trial to Establish Reduction of CHD Risk. Pivotal Proof-of-Efficacy Clinical Trials in the Treatment of Panic Disorder. Combination Clinical Trials. Monitoring Clinical Trials for Adverse Events. Index.