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European Pharmaceutical Contractor

A Comprehensive Account

 

First published in 2011, Global Clinical Trials: Effective Implementation and Management gives a global overview of conducting clinical trials. Its introductory chapter provides bioethical consideration of clinical trials in emerging regions, together with sections on conducting trials in the more traditional regions. US, EU and Japanese regulations are all considered in this section. Although the harmonisation of GCP across the three major developed markets has been a significant advance in drug development and immensely aided the growth of global clinical trials, the International Conference on Harmonisation (ICH) must continue to be developed further. Regulations are not completely harmonised, since every region can add additional requirements, and in many regions these requirements are being added on a regular basis. For this reason it is necessary to keep in touch on an almost daily basis with the regulatory authorities in countries in which you might be wishing to carry out these trials. This is particularly relevant in the developing nations, which are dealt with in subsequent chapters.

Bioethical considerations for trials in developing countries are discussed in section 2, concentrating in particular on India, China, Taiwan, Philippines, Middle East and North Africa, South Africa, Latin America and central and eastern Europe. While many readers will be familiar with the regulations and conditions of running clinical trials in eastern Europe and perhaps India, the sections on less well known countries will be of particular use.

The final section of the book addresses the logistics of conducting clinical trials in multiple countries. In particular it focuses on the design, management and documentation of clinical trials for emerging countries, and how best these studies can be monitored and conducted. In the final chapter, data collection, data management and electronic data capture are also considered. One particularly important consideration that the book recommends is to recognise the opportunities and challenges in effectively designing and conducting clinical trials in emerging countries. Post-trial design and conduct must be carried out so as to maximise the advantages and above all minimise the risks associated with these emerging countries. The specifics of a trial will certainly influence protocol design and trial planning, and issues relating to conducting clinical trials in emerging regions are normally universally applicable, whether this country be in South America, sub-Saharan Africa or South East Asia.

What is particularly impressive in this book is the fine level of detail that is laid out in terms of regulatory affairs and other considerations for virtually every region considered. The authors are drawn from both industry and academia, and address critical issues often seen in global clinical trials. The scope is comprehensive, covering virtually every continent. The book is impressively up-to-date, with references dating up to the end of 2010. With an increasing number of clinical trials being conducted on a global basis this book is very timely, particularly because studies in developing countries often pose specific challenges, so advice on addressing these will be particularly welcome to the clinical trial community.

Global Clinical Trials may prove to be a landmark publication and a standard reference book for many years to come. The only reservation one might have is that regulations are constantly evolving, so its coverage may soon become out-of-date. We would certainly expect and indeed look forward to future, updated editions.


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Edited by Richard Chin
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Menghis Bairu
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