Book Cover
E-book
Author Peace, Karl E

Title Clinical Trial Methodology
Published Hoboken : CRC Press, 2010

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Description 1 online resource (422 pages)
Series Chapman & Hall/CRC Biostatistics Series, 35
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
Notes Print version record
Subject Clinical trials.
Drugs -- Testing.
Clinical Trials as Topic
Clinical trials
Drugs -- Testing
Form Electronic book
ISBN 9781584889182
1584889187