LEADER 05074oam 2200637I 450 001 9910458853903321 005 20200520144314.0 010 $a0-429-14207-2 010 $a1-58488-918-7 024 7 $a10.1201/EBK1584889175 035 $a(CKB)2670000000033117 035 $a(EBL)555711 035 $a(OCoLC)652654235 035 $a(SSID)ssj0000414237 035 $a(PQKBManifestationID)11307058 035 $a(PQKBTitleCode)TC0000414237 035 $a(PQKBWorkID)10401383 035 $a(PQKB)10085636 035 $a(MiAaPQ)EBC555711 035 $a(Au-PeEL)EBL555711 035 $a(CaPaEBR)ebr10405036 035 $a(CaONFJC)MIL694454 035 $a(EXLCZ)992670000000033117 100 $a20180331d2011 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aClinical trial methodology /$fKarl E. Peace, Ding-Geng (Din) Chen 210 1$aBoca Raton :$cChapman and Hall/CRC Press,$d2011. 215 $a1 online resource (422 p.) 225 1 $aChapman & Hall/CRC biostatistics series ;$v35 300 $aDescription based upon print version of record. 311 $a1-322-63172-7 311 $a1-58488-917-9 320 $aIncludes bibliographical references and index. 327 $aFront 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 327 $aChapter 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 Risk 327 $aChapter 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 cover 330 $aNow viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. Drawing from the authors courses on the subject as well as the first authors more than 30 years working in the pharmaceutical industry, Clinical Trial Methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research. From ethical issues and sample size considerations to adaptive design procedures and statistical analysis, the book first covers the methodology that spans every clinical trial regardless of the area of application. Crucial to the generic drug industry, bioequivalence clinical trials are then discussed. The authors describe a parallel bioequivalence clinical trial of six formulations incorporating group sequential procedures that permit sample size re-estimation. The final chapters incorporate real-world case studies of clinical trials from the authors own experiences. These examples include a landmark Phase III clinical trial involving the treatment of duodenal ulcers and Phase III clinical trials that contributed to the first drug approved for the treatment of Alzheimers disease. Aided by the U.S. FDA, the U.S. National Institutes of Health, the pharmaceutical industry, and academia, the area of clinical trial methodology has evolved over the last six decades into a scientific discipline. This guide explores the processes essential for developing and conducting a quality clinical trial protocol and providing quality data collection, biostatistical analyses, and a clinical study report, all while maintaining the highest standards of ethics and excellence--Provided by publisher. 410 0$aChapman & Hall/CRC biostatistics series ;$v35. 606 $aClinical trials 606 $aDrugs$xTesting 608 $aElectronic books. 615 0$aClinical trials. 615 0$aDrugs$xTesting. 676 $a615.5072/4 700 $aPeace$b Karl E.$f1941,$0863165 701 $aChen$b Ding-Geng$0863166 801 0$bFlBoTFG 801 1$bFlBoTFG 906 $aBOOK 912 $a9910458853903321 996 $aClinical trial methodology$91926880 997 $aUNINA