Clinical Trials Handbook

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.

Best practices for conducting effective and safe clinicaltrialsClinical trials are arguably the most important steps in provingdrug effectiveness and safety for public use. They requireintensive planning and organization and involve a wide range ofdisciplines: data management, biostatistics, pharmacologytoxicology, modeling and simulation, regulatory monitoring, ethicsand particular issues for given disease areas. Clinical TrialsHandbook provides a comprehensive and thorough reference on thebasics and practices of clinical trials.With contributions from a range of international authors, thebook takes the reader through each trial phase, technique, andissue. Chapters cover every key aspect of preparing and conductingclinical trials, including:* Interdisciplinary topics that have to be coordinated for asuccessful clinical trialData management (and adverse eventreporting systems)* Biostatistics, pharmacology, and toxicology* Modeling and simulation* Regulatory monitoring and ethics* Particular issues for given disease areas-cardiology, oncologycognitive, dementia, dermatology, neuroscience, and moreWith unique information on such current issues as adverse eventreporting (AER) systems, adaptive trial designs, and crossovertrial designs, Clinical Trials Handbook will be a readyreference for pharmaceutical scientists, statisticiansresearchers, and the many other professionals involved in drugdevelopment.