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.