05074oam 2200637I 450 991045885390332120200520144314.00-429-14207-21-58488-918-710.1201/EBK1584889175 (CKB)2670000000033117(EBL)555711(OCoLC)652654235(SSID)ssj0000414237(PQKBManifestationID)11307058(PQKBTitleCode)TC0000414237(PQKBWorkID)10401383(PQKB)10085636(MiAaPQ)EBC555711(Au-PeEL)EBL555711(CaPaEBR)ebr10405036(CaONFJC)MIL694454(EXLCZ)99267000000003311720180331d2011 uy 0engur|n|---|||||txtccrClinical trial methodology /Karl E. Peace, Ding-Geng (Din) ChenBoca Raton :Chapman and Hall/CRC Press,2011.1 online resource (422 p.)Chapman & Hall/CRC biostatistics series ;35Description based upon print version of record.1-322-63172-7 1-58488-917-9 Includes bibliographical references and index.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 TrialsChapter 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 Ulceration; Chapter 14: Clinical Trials in the Treatmentof Alzheimer's Disease Based uponEnrichment Designs; Chapter 15: A Clinical Trial to Establish Reductionof CHD RiskChapter 16: Pivotal Proof-of-Efficacy Clinical Trialsin the Treatment of Panic DisorderChapter 17: Combination Clinical Trials; Chapter 18: Monitoring Clinical Trials for Adverse Events; Index; Back coverNow 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 authors 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 Alzheimers 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--Provided by publisher.Chapman & Hall/CRC biostatistics series ;35.Clinical trialsDrugsTestingElectronic books.Clinical trials.DrugsTesting.615.5072/4Peace Karl E.1941,863165Chen Ding-Geng863166FlBoTFGFlBoTFGBOOK9910458853903321Clinical trial methodology1926880UNINA