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Title Clinical Trial Methodology.
Imprint Hoboken : CRC Press, 2010.


 Internet  Electronic Book    AVAILABLE
Description 1 online resource (422 pages)
Series Chapman & Hall/CRC Biostatistics Series, 35
Note Available only to authorized UTEP users.
Print version record.
Subject Clinical trials.
Drugs -- Testing.
Contents Front cover; Contents; Preface; Chapter 1: Overview of Clinical Trial Methodology; Chapter 2: Overview of the Drug Development Processand Regulation of Clinical Trials; Chapter 3: Ethical Considerations in the Designand Conduct of Clinical Trials; Chapter 4: Sample Size Considerations in ClinicalTrials Pre-Market Approval; Chapter 5: Sequential, Group Sequential, StochasticCurtailment, and Adaptive DesignProcedures in Clinical Trials; Chapter 6: Biostatistical Aspects of the Protocol; Chapter 7: The Statistical Analysis Plan; Chapter 8: Pooling of Data from Multicenter Clinical Trials.
Chapter 9: Validity of Statistical InferenceChapter 10: Bioequivalence Clinical Trials; Chapter 11: Dose and Frequency Determinationfrom Phase II Clinical Trials in StressTest-Induced Angina; Chapter 12: Confirmation of Clinically Optimal Dosingin the Treatment of Duodenal Ulcers:A Phase III Dose Comparison Trial; Chapter 13: Pivotal Proof-of-Efficacy Clinical Trialsin the Prevention of NANSAID-InducedGastric Ulcera.
Summary 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 various clinical trials.
Other Title Print version: Peace, Karl E. Clinical Trial Methodology. Hoboken : CRC Press, ©2010 9781584889175