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 |
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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.
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Drugs -- Testing.
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Clinical Trials as Topic
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Clinical trials
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Drugs -- Testing
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Form |
Electronic book
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ISBN |
9781584889182 |
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1584889187 |
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