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001400565 020__ $$z9781482212181 (hardback)
001400565 020__ $$a9781482212198 (e-book)
001400565 035__ $$a(MiAaPQ)EBC1718539
001400565 035__ $$a(Au-PeEL)EBL1718539
001400565 035__ $$a(CaPaEBR)ebr10961770
001400565 035__ $$a(CaONFJC)MIL695142
001400565 035__ $$a(OCoLC)894169697
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001400565 050_4 $$aR853.S7$$bC55 2015
001400565 0820_ $$a610.72/7$$223
001400565 24500 $$aClinical trial biostatistics and biopharmaceutical applications /$$cedited by Walter R. Young, Ding-Geng (Din) Chen.
001400565 264_1 $$aBoca Raton :$$bCRC Press,$$c[2015]
001400565 264_4 $$c©2015
001400565 300__ $$a1 online resource (574 pages) :$$billustrations.
001400565 336__ $$atext$$2rdacontent
001400565 337__ $$acomputer$$2rdamedia
001400565 338__ $$aonline resource$$2rdacarrier
001400565 500__ $$a"A Chapman & Hall book."
001400565 504__ $$aIncludes bibliographical references and index.
001400565 506__ $$aAccess limited to authorized users.
001400565 520__ $$a"Since 1945, "The Annual Deming Conference on Applied Statistics" has been an important event in the statistics profession. In Clinical Trial Biostatistics and Biopharmaceutical Applications, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical trials as well as up-to-date biostatistical applications from the pharmaceutical industry. Divided into five sections, the book begins with emerging issues in clinical trial design and analysis, including the roles of modeling and simulation, the pros and cons of randomization procedures, the design of Phase II dose-ranging trials, thorough QT/QTc clinical trials, and assay sensitivity and the constancy assumption in noninferiority trials. The second section examines adaptive designs in drug development, discusses the consequences of group-sequential and adaptive designs, and illustrates group sequential design in R. The third section focuses on oncology clinical trials, covering competing risks, escalation with overdose control (EWOC) dose finding, and interval-censored time-to-event data. In the fourth section, the book describes multiple test problems with applications to adaptive designs, graphical approaches to multiple testing, the estimation of simultaneous confidence intervals for multiple comparisons, and weighted parametric multiple testing methods. The final section discusses the statistical analysis of biomarkers from omics technologies, biomarker strategies applicable to clinical development, and the statistical evaluation of surrogate endpoints.This book clarifies important issues when designing and analyzing clinical trials, including several misunderstood and unresolved challenges. It will help readers choose the right method for their biostatistical application. Each chapter is self-contained with references"--Provided by publisher.
001400565 588__ $$aDescription based on print version record.
001400565 650_0 $$aMedicine$$xResearch$$xStatistical methods.
001400565 650_0 $$aClinical trials$$xMethodology.
001400565 655_0 $$aElectronic books
001400565 7001_ $$aYoung, Walter R.,$$eeditor.
001400565 7001_ $$aChen, Ding-Geng,$$eeditor.
001400565 77608 $$iPrint version:$$tClinical trial biostatistics and biopharmaceutical applications.$$dBoca Raton : CRC Press, [2015]$$z9781482212181$$w(DNLM)101643609$$w(DLC)10961770
001400565 852__ $$bebk
001400565 85640 $$3ProQuest Ebook Central Academic Complete $$uhttps://univsouthin.idm.oclc.org/login?url=https://ebookcentral.proquest.com/lib/usiricelib-ebooks/detail.action?docID=1718539$$zOnline Access
001400565 909CO $$ooai:library.usi.edu:1400565$$pGLOBAL_SET
001400565 980__ $$aBIB
001400565 980__ $$aEBOOK
001400565 982__ $$aEbook
001400565 983__ $$aOnline