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 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.
From ethical issues and sample size considerations to adaptive
design procedures and statistical analysis, the book first covers
the methodology that spans every clinical trial regardless of the
area of application. Crucial to the generic drug industry,
bioequivalence clinical trials are then discussed. The authors
describe a parallel bioequivalence clinical trial of six
formulations incorporating group sequential procedures that permit
sample size re-estimation. The final chapters incorporate
real-world case studies of clinical trials from the authors' own
experiences. These examples include a landmark Phase III clinical
trial involving the treatment of duodenal ulcers and Phase III
clinical trials that contributed to the first drug approved for the
treatment of Alzheimer's disease.
Aided by the U.S. FDA, the U.S. National Institutes of Health,
the pharmaceutical industry, and academia, the area of clinical
trial methodology has evolved over the last six decades into a
scientific discipline. This guide explores the processes essential
for developing and conducting a quality clinical trial protocol and
providing quality data collection, biostatistical analyses, and a
clinical study report, all while maintaining the highest standards
of ethics and excellence.
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