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

chapter 1|8 pages

Overview of Clinical Trial Methodology

chapter 6|14 pages

Biostatistical Aspects of the Protocol

chapter 7|10 pages

The Statistical Analysis Plan

chapter 9|10 pages

Validity of Statistical Inference

chapter 10|54 pages

Bioequivalence Clinical Trials

chapter 17|14 pages

Combination Clinical Trials