Clinical Trial Methodology: 35 (Chapman & Hall/CRC Biostatistics Series) - Hardcover

Peace, Karl E.; Chen, Ding-Geng (Din)

Hardcover

ISBN 10: 1584889179 ISBN 13: 9781584889175

Publisher: Chapman and Hall/CRC, 2010

Synopsis

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.

About this title

Review

This comprehensive text introduces the key areas of clinical trial methodology from the perspective of the biostatistician in the pharmaceutical industry. ... Throughout, the text benefits from a highly structured and logical flow ... the arguments made in the book are grounded in many years of practical experience in drug development and at the very least will act as a prompt for in-depth discussion or critical review of one’s own perceptions. ... Clinical Trial Methodology will be of substantial value to early career pharmaceutical industry statisticians.
―Christopher J. Weir, Pharmaceutical Statistics, 2012

... informative discussions of mechanisms such as IND and NDA ... are unique strengths of this book, distinguishing it from the many other clinical trial texts available. ... Case studies ... are presented carefully ... The authors’ writing style is disciplined, careful, and informative. ... this is a helpful and informative book, a nice reference to have for most biostatisticians working on clinical trials.
―Mithat Gönen, Journal of Biopharmaceutical Statistics, 21, 2011

The book is an excellent overview predicated on the first author’s seasoned experiences in designing, analyzing, and communicating the results of clinical trials across a broad number of medical disciplines. ... A nice introductory feature is the history of drug law and regulation, which helps to frame the subsequent statistical discussion nicely. ... The real-world examples that dominate the last few chapters are fantastic. ... There is nothing like a series of examples from an experienced clinical trialist to whet the appetite of those involved in the noble enterprise of medical (and more specifically pharmaceutical) research with the goal of improving the public’s health. This book does an admirable job in giving the regulatory and statistical foundations for clinical trials, coupled with real-world examples of how statistical methodology has guided the development of important medicines. ...
―Gregory Enas

About the Author

Karl E. Peace is the Georgia Cancer Coalition Distinguished Cancer Scholar, founding director of the Center for Biostatistics, and professor of biostatistics in the Jiann-Ping Hsu College of Public Health at Georgia Southern University.

Din Chen is the Karl E. Peace Endowed Eminent Scholar Chair in Biostatistics and professor of biostatistics in the Jiann-Ping Hsu College of Public Health at Georgia Southern University.

Edition details

• Publisher: Chapman and Hall/CRC
• Publication date: 2010
• ISBN 10: 1584889179
• ISBN 13: 9781584889175
• Binding: Hardcover
• Language: English
• Edition number: 1
• Number of pages: 420