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.

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.).

Preface. 1 Introduction to Clinical Trials (John Goffin). 2 Regulatory Requirements for Investigational New Drug (Venkat Rao). 3 Preclinical Assessment of Safety in Human Subjects (Nancy Wintering and Andrew B. Newberg). 4 Predicting human adverse drug reactions from non-clinical safety studies (Jean-Pierre Valentin, Marianne Keisu Pinheiro, Anthony Rossini, Heinz Schmidli, Jean-Louis Steimer, Jing Yu). 20 Monitoring (Nigel Stallard and Susan Todd). 21 Inference Following a Sequential Clinical Trial (Aiyi Liu and Kai F. Yu). 22 Statistical methods for Analysis of Clinical Trials (Duolao Wang, Ameet Bakhai, and Nicola Maffulli). 23 Explanatory and Pragmatic Clinical Trials (Rob Herbert). 24.1 Ethics of Clinical Research in Durg Trials (Roy G. Beran). 24.2 Ethical Issues in Clinical Research (Kelton Tremellen and David Belford). 25 Regulations (Ramzi Dagher, Rajeshwari Sridhara, Nallaperumal Chidambaram, and Brian P. Booth). 26 Future Challenges in the Design and Ethics of Clinical Trials (Carl-Fredrik Burman and Axel Carlberg). 27 Proof-of-Principle/Proof-of-Concept trials in Drug Development (Ayman Al-Shurbaji).