Clinical Trials Handbook

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