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International Clinical Trials

Playing the Field


Graham Hughes reviews Global Clinical Trials Playbook – Capacity and Capability Building and explains why it is a good point of reference for clinical trials

I recently reviewed a book entitled Principles and Practice of Clinical Research. I criticised this book for being overly theoretical and written by academics without any contribution from industry clinical research professionals. The book also seemed to me to be too concentrated on the US. The latest book to come across my desk, Global Clinical Trials Playbook, is almost the exact reverse; there are many contributions from industry professionals, it is a very practical guide on how clinical trials should be conducted, and it has a very international feel to it.

The book is divided into seven sections dealing with: the principles of clinical trials; how to manage clinical trial sites; regulatory issues; pharmacovigilance; electronic data capture ethics and intellectual property; and quality assurance and data management. It also has appendices of considerable utility with sample protocol templates, informed consent forms and so on. Within the chapter on clinical trials there is a lengthy discussion on how to select and oversee CROs. The issues of financial forecasting, budgeting and project management are not overlooked. I commented earlier that the book is international in vision, discussing lessons learned in India, China, eastern Europe, Singapore and Turkey, while other chapters discuss effective models in Africa.

The book begins with a quotation from Fergus Sweeney, who was Head of Inspections of the European Medicines Agency: “wherever in the world we stand the majority of clinical trials are being conducted somewhere else in the world under a different regulatory framework and in different cultural setting; however, we all rely on the same trials to make decisions, as regulators to allow or disallow marketing authorisations and as patients and healthcare providers to use or not to use a particular medicine”. This book helps both the uninitiated and the experienced to find their way through the maze of regulations, procedures and protocols that are involved in clinical trial management and the eventual approval of regulatory dossiers by the various competent authorities.

The book brings together a panoply of academics, registration professionals, safety officers and other experts from the pharmaceutical industry and CROs, whose objective is to present a detailed step-by-step guide book on running clinical trials in the global sphere in both developing and emerging markets. The book uses real-life examples to present the tools available to build and enhance human capacity in order to execute clinical trials throughout the world, and is recommended for anybody interested in expanding their knowledge of international clinical trials.

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Global Clinical Trials Playbook– Capacity and Capability Building
Edited by Menghis Bairu and Richard Chin Elsevier ISBN 978-0-12-415787-3
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Graham Hughes
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