Clinical Trial Methodology [Print Replica] [Format Kindle] Author: Peace Karl E. | Language: English | ISBN:
B008KZC622 | Format: PDF, EPUB
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Présentation de l'éditeur
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 author’s 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 Alzheimer’s 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.
Biographie de l'auteur
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.
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NIH Clinical Center Clinical Trial Methodology Feb 13 2014 Advanced knowledge of both clinical trial methodology and the regulatory pathways leading to approval of new treatments for or Dr Billy Dunn Clinical Trial Methodology CRC Press Book Editorial Reviews This comprehensive text introduces the key areas of clinical trial methodology from the perspective of the biostatistician in the pharmaceutical PPD Acquires RCT Logic s Exclusive License to Patented Sep 03 2014 SPCD is an alternative method for conducting well controlled clinical trials that of the SPCD methodology in more than 10 trials ClinicalTrials gov Official Site ClinicalTrials gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world Clinical Research Methodology SlideShare Jan 10 2010 Clinical Research Methodology Aims and Objectives Be able to Steps in Designing Clinical Trial Rationale Hypothesis Type of trial
Great book. Was my Semester Text book. Very detailed, from a great teacher.Strongly recommend it. There may be later versions, I wish the data-sets came on Cd's so that its easy to copy that into SAS, or it had a link to a website where u can download the data-sets examples.
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