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| Preface | |
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| Contributors | |
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| Introduction to Clinical Trials | |
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| Regulatory Requirements for Investigational New Drug | |
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| Preclinical Assessment of Safety in Human Subjects | |
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| Predicting Human Adverse Drug Reactions from Nonclinical Safety Studies | |
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| History of Clinical Trial Development and the Pharmaceutical Industry | |
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| Adaptive Research | |
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| Organization and Planning | |
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| Process of Data Management | |
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| Clinical Trials Data Management | |
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| Clinical Trials and the Food and Drug Administration | |
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| Phase I Clinical Trials | |
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| Phase II Clinical Trials | |
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| Designing and Conducting Phase III Studies | |
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| Phase IV: Postmarketing Trials | |
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| Phase IV and Postmarketing Clinical Trials | |
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| Regulatory Approval | |
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| New Paradigm for Analyzing Adverse Drug Events | |
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| Clinical Trials in Interventional Cardiology: Focus on XIENCE Drug-Eluting Stent | |
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| Clinical Trials Involving Oral Diseases | |
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| Dermatology Clinical Trials | |
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| Emergency Clinical Trials | |
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| Gastroenterology Lise Lotte Gluud and J�rgen Rask-Madsen | |
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| Gynecology Randomized Control Trials Khalid S. Khan, Tara Selman, and Jane Daniels | |
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| Special Population Studies (Healthy Patient Studies) | |
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| Musculoskeletal Disorders | |
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| Oncology | |
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| Pharmacological Treatment Options for Nonexudative and Exudative Age-Related Macular Degeneration | |
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| Paediatrics | |
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| Clinical Trials in Dementia | |
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| Clinical Trials in Urology | |
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| Clinical Trials on Cognitive Drugs | |
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| Bridging Studies in Pharmaceutical Safety Assessment | |
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| Brief History of Clinical Trials on Viral Vaccines | |
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| Methods of Randomization | |
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| Randomized Controlled Trials | |
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| Cross-Over Designs | |
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| Biomarkers | |
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| Biomarkers in Clinical Drug Development: Parallel Analysis of Alzheimer Disease and Multiple Sclerosis | |
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| Review Boards | |
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| Size of Clinical Trials | |
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| Blinding and Placebo | |
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| Pharmacology | |
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| Modeling and Simulation in Clinical Drug Development | |
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| Monitoring | |
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| Inference Following Sequential Clinical Trials | |
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| Statistical Methods for Analysis of Clinical Trials | |
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| Explanatory and Pragmatic Clinical Trials | |
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| Ethics of Clinical Research in Durg Trials | |
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| Ethical Issues in Clinical Research | |
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| Regulations | |
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| Future Challenges in Design and Ethics of Clinical Trials | |
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| Proof-of-Principle/Proof-of-Concept Trials in Drug Development | |
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| Index | |