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Clinical Trial Methodology (Paperback)
Loot Price: R1,498
Discovery Miles 14 980
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Clinical Trial Methodology (Paperback)
Series: Chapman & Hall/CRC Biostatistics Series
Expected to ship within 12 - 17 working days
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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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