Clinical Trials Handbook.
Title:
Clinical Trials Handbook.
Author:
Gad, Shayne Cox.
ISBN:
9780470466353
Personal Author:
Edition:
1st ed.
Physical Description:
1 online resource (1247 pages)
Series:
Pharmaceutical Development Series ; v.8
Pharmaceutical Development Series
Contents:
Clinical Trials Handbook -- Contents -- Preface -- Contributors -- 1 Introduction to Clinical Trials -- 2 Regulatory Requirements for Investigational New Drug -- 3 Preclinical Assessment of Safety in Human Subjects -- 4 Predicting Human Adverse Drug Reactions from Nonclinical Safety Studies -- 5.1 History of Clinical Trial Development and the Pharmaceutical Industry -- 5.2 Adaptive Research -- 6 Organization and Planning -- 7 Process of Data Management -- 8 Clinical Trials Data Management -- 9.1 Clinical Trials and the Food and Drug Administration -- 9.2 Phase I Clinical Trials -- 9.3 Phase II Clinical Trials -- 9.4 Designing and Conducting Phase III Studies -- 9.5 Phase IV: Postmarketing Trials -- 9.6 Phase IV and Postmarketing Clinical Trials -- 9.7 Regulatory Approval -- 9.8 New Paradigm for Analyzing Adverse Drug Events -- 10.1 Clinical Trials in Interventional Cardiology: Focus on XIENCE Drug-Eluting Stent -- 10.2 Clinical Trials Involving Oral Diseases -- 10.3 Dermatology Clinical Trials -- 10.4 Emergency Clinical Trials -- 10.5 Gastroenterology -- 10.6 Gynecology Randomized Control Trials -- 10.7 Special Population Studies (Healthy Patient Studies) -- 10.8 Musculoskeletal Disorders -- 10.9 Oncology -- 10.10 Pharmacological Treatment Options for Nonexudative and Exudative Age-Related Macular Degeneration -- 10.11 Paediatrics -- 10.12 Clinical Trials in Dementia -- 10.13 Clinical Trials in Urology -- 10.14 Clinical Trials on Cognitive Drugs -- 10.15 Bridging Studies in Pharmaceutical Safety Assessment -- 10.16 Brief History of Clinical Trials on Viral Vaccines -- 11 Methods of Randomization -- 12 Randomized Controlled Trials -- 13 Cross-Over Designs -- 14.1 Biomarkers -- 14.2 Biomarkers in Clinical Drug Development: Parallel Analysis of Alzheimer Disease and Multiple Sclerosis -- 15 Review Boards -- 16 Size of Clinical Trials.
17 Blinding and Placebo -- 18 Pharmacology -- 19 Modeling and Simulation in Clinical Drug Development -- 20 Monitoring -- 21 Inference Following Sequential Clinical Trials -- 22 Statistical Methods for Analysis of Clinical Trials -- 23 Explanatory and Pragmatic Clinical Trials -- 24.1 Ethics of Clinical Research in Durg Trials -- 24.2 Ethical Issues in Clinical Research -- 25 Regulations -- 26 Future Challenges in Design and Ethics of Clinical Trials -- 27 Proof-of-Principle/Proof-of-Concept Trials in Drug Development -- Index.
Abstract:
Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
Local Note:
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2017. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
Genre:
Electronic Access:
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