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

Clinical Trial Methodology (eBook, PDF)

• Format: PDF

Produktbeschreibung

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. Bioequivalence clinical trials are then discussed. The final chapters incorporate real-world case studies of clinical trials from the authors' own experiences.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 420
• Erscheinungstermin: 20. Juli 2010
• Englisch
• ISBN-13: 9781584889182
• Artikelnr.: 57533565

Autorenporträt

Karl E. Peace is the Georgia Cancer Coalition Distinguished Cancer Scholar, founding director of the Center for Biostatistics, and professor of biostatistics in the Jiann-Ping Hsu College of Public Health at Georgia Southern University.

Din Chen is the Karl E. Peace Endowed Eminent Scholar Chair in Biostatistics and professor of biostatistics in the Jiann-Ping Hsu College of Public Health at Georgia Southern University.

Inhaltsangabe

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.