Clinical trial biostatistics and biopharmaceutical applications:
Gespeichert in:
| Format: | Elektronisch E-Book |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Boca Raton
CRC Press
[2015]
|
| Schlagworte: | |
| Beschreibung: | "A Chapman & Hall book." Includes bibliographical references and index "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 |
| Beschreibung: | 1 Online-Ressource (574 pages) |
| ISBN: | 9781482212198 |
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| spelling | Clinical trial biostatistics and biopharmaceutical applications edited by Walter R. Young, Ding-Geng (Din) Chen Boca Raton CRC Press [2015] 1 Online-Ressource (574 pages) txt rdacontent c rdamedia cr rdacarrier "A Chapman & Hall book." Includes bibliographical references and index "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 Medizin Medicine Research Statistical methods Clinical trials Methodology Electronic books 1\p (DE-588)4143413-4 Aufsatzsammlung gnd-content Young, Walter R. Sonstige oth Chen, Ding-Geng Sonstige oth Erscheint auch als Druck-Ausgabe, Hardcover 978-1-4822-1218-1 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Clinical trial biostatistics and biopharmaceutical applications Medizin Medicine Research Statistical methods Clinical trials Methodology |
| subject_GND | (DE-588)4143413-4 |
| title | Clinical trial biostatistics and biopharmaceutical applications |
| title_auth | Clinical trial biostatistics and biopharmaceutical applications |
| title_exact_search | Clinical trial biostatistics and biopharmaceutical applications |
| title_full | Clinical trial biostatistics and biopharmaceutical applications edited by Walter R. Young, Ding-Geng (Din) Chen |
| title_fullStr | Clinical trial biostatistics and biopharmaceutical applications edited by Walter R. Young, Ding-Geng (Din) Chen |
| title_full_unstemmed | Clinical trial biostatistics and biopharmaceutical applications edited by Walter R. Young, Ding-Geng (Din) Chen |
| title_short | Clinical trial biostatistics and biopharmaceutical applications |
| title_sort | clinical trial biostatistics and biopharmaceutical applications |
| topic | Medizin Medicine Research Statistical methods Clinical trials Methodology |
| topic_facet | Medizin Medicine Research Statistical methods Clinical trials Methodology Aufsatzsammlung |
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