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Clinical trial methodology

Chen, Ding-Geng.

Clinical trial methodology

Record Type:	Electronic resources : Monograph/item
Title/Author:	Clinical trial methodologyKarl E. Peace, Ding-Geng (Din) Chen.
Author:	Peace, Karl E.,
other author:	Chen, Ding-Geng.
Published:	Boca Raton :Chapman and Hall/CRC Press,2011.
Description:	420 p.
Subject:	Clinical trials.
Online resource:	Distributed by publisher. Purchase or institutional license may be required for access.
ISBN:	9781584889182 (e-book : PDF)

Clinical trial methodology
Peace, Karl E.,1941-

Clinical trial methodology[electronic resource] /Karl E. Peace, Ding-Geng (Din) Chen. - Boca Raton :Chapman and Hall/CRC Press,2011. - 420 p. - Chapman & Hall/CRC biostatistics series ;35. - Chapman & Hall/CRC biostatistics series ;38..

Includes bibliographical references and index.

"Now 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.

Mode of access: World Wide Web.

ISBN: 9781584889182 (e-book : PDF)Subjects--Topical Terms:

181901
Clinical trials.
Index Terms--Genre/Form:

214472
Electronic books.

Clinical trial methodology
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245 1 0 $a Clinical trial methodology $h [electronic resource] / $c Karl E. Peace, Ding-Geng (Din) Chen.
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300 $a 420 p.
490 1 $a Chapman & Hall/CRC biostatistics series ; $v 35
504 $a Includes bibliographical references and index.
520 $a "Now 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.
530 $a Also available in print edition.
538 $a Mode of access: World Wide Web.
650 0 $a Clinical trials. $3 181901
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655 7 $a Electronic books. $2 local. $3 214472
700 1 $a Chen, Ding-Geng. $3 487343
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830 0 $a Chapman & Hall/CRC biostatistics series ; $v 38. $3 487298
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