Clinical Trials Handbook

This book provides a comprehensive and thorough reference on the basics and practices of clinical trials, arguably the most important steps in proving a drug effective and safe for public use. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters include interdisciplinary topics that have to be coordinated for a successful clinical trial: data management (and adverse event reporting systems), biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas (ie, cardiology, oncology, neuroscience, etc.).

Shayne Cox Gad, PhD, DABT, ATS, is the Principal of Gad Consulting Services. Dr. Gad has more than thirty years of experience as a toxicologist, statistical consultant, manager, and general consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is the author of thirty-nine books and numerous papers, presentations, and other publications.

Preface	p. xi
Contributors	p. xiii
Introduction to Clinical Trials	p. 1
Regulatory Requirements for Investigational New Drug	p. 23
Preclinical Assessment of Safety in Human Subjects	p. 71
Predicting Human Adverse Drug Reactions from Nonclinical Safety Studies	p. 87
History of Clinical Trial Development and the Pharmaceutical Industry	p. 115
Adaptive Research	p. 135
Organization and Planning	p. 161
Process of Data Management	p. 185
Clinical Trials Data Management	p. 203
Clinical Trials and the Food and Drug Administration	p. 227
Phase I Clinical Trials	p. 245
Phase II Clinical Trials	p. 255
Designing and Conducting Phase III Studies	p. 279
Phase IV: Postmarketing Trials	p. 303
Phase IV and Postmarketing Clinical Trials	p. 325
Regulatory Approval	p. 349
New Paradigm for Analyzing Adverse Drug Events	p. 373
Clinical Trials in Interventional Cardiology: Focus on XIENCE Drug-Eluting Stent	p. 397
Clinical Trials Involving Oral Diseases	p. 435
Dermatology Clinical Trials	p. 461
Emergency Clinical Trials	p. 477
Gastroenterology Lise Lotte Gluud and J¿rgen Rask-Madsen	p. 501
Gynecology Randomized Control Trials Khalid S. Khan, Tara Selman, and Jane Daniels	p. 519
Special Population Studies (Healthy Patient Studies)	p. 531
Musculoskeletal Disorders	p. 563
Oncology	p. 587
Pharmacological Treatment Options for Nonexudative and Exudative Age-Related Macular Degeneration	p. 607
Paediatrics	p. 627
Clinical Trials in Dementia	p. 661
Clinical Trials in Urology	p. 695
Clinical Trials on Cognitive Drugs	p. 705
Bridging Studies in Pharmaceutical Safety Assessment	p. 733
Brief History of Clinical Trials on Viral Vaccines	p. 769
Methods of Randomization	p. 779
Randomized Controlled Trials	p. 807
Cross-Over Designs	p. 823
Biomarkers	p. 851
Biomarkers in Clinical Drug Development: Parallel Analysis of Alzheimer Disease and Multiple Sclerosis	p. 869
Review Boards	p. 895
Size of Clinical Trials	p. 913
Blinding and Placebo	p. 933
Pharmacology	p. 949
Modeling and Simulation in Clinical Drug Development	p. 989
Monitoring	p. 1019
Inference Following Sequential Clinical Trials	p. 1043
Statistical Methods for Analysis of Clinical Trials	p. 1053
Explanatory and Pragmatic Clinical Trials	p. 1081
Ethics of Clinical Research in Durg Trials	p. 1099
Ethical Issues in Clinical Research	p. 1111
Regulations	p. 1153
Future Challenges in Design and Ethics of Clinical Trials	p. 1173
Proof-of-Principle/Proof-of-Concept Trials in Drug Development	p. 1201
Index	p. 1219
Table of Contents provided by Ingram. All Rights Reserved.

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Clinical Trials Handbook

Summary

Author Biography

Table of Contents

Supplemental Materials

FREE SHIPPING

Rent More, Save More! Use code: BBRENTAL

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Clinical Trials Handbook

Summary

Author Biography

Table of Contents

Supplemental Materials

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