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Book Review: Principles of Clinical Research

Ed. Di Giovanna & Hayes Posted on: 29 Jan 02


The phrase ‘The Bible of …’ is too often bandied about both by publishers and readers but in the case of ‘The Principles of Clinical Research’ it is more accurate than most.
The phrase ‘The Bible of …’ is too often bandied about both by publishers and readers but in the case of ‘The Principles of Clinical Research’ it is more accurate than most. The book, published in 2001, is the successor to 1994’s ‘Handbook of Clinical Research’. The original, revised in 1997, was put together by the Institute of Clinical Research, the UK based organisation for clinical development professionals ( and attempted to give an overview of the “multi-disciplinary, multi-national and multi-billion” dollar industry that is Clinical Research. The Handbook proved an invaluable tool for both established Clinical Researchers and those trying to get a foothold in this exciting discipline. However the changes in the industry, and particularly in the Clinical Trials process have demanded that the Handbook be more than just revised. ‘The Principles of Clinical Research’, then, is the Institute’s attempt to provide a guide to the planning, organisation and management of Clinical Trials. Clinical Trials have come a long way since the 1950’s, when it was not uncommon for a drug to be marketed after trials with as few as 30 patients. Clinical Trials in the 21st Century cross borders, involve thousands of patients and produce reams of data and no individual could ever hope to create a defining work encompassing all the disciplines involved. The Institute have therefore taken the logical route and called on a number of writers to produce chapters for the book. The 24 chapters that result cover everything from trial design, to legal liability, from investigator selection through to archiving, each chapter addressed by an expert in the field. The major companies are, of course, well represented, with chapters having been contributed by employees of GlaxoSmithKline, AstraZeneca, Quintiles and PAREXEL. There are also significant contributions from representatives of the more specialised companies including excellent chapters by Elizabeth Hooper of Phlex on archiving and the closing chapter on Fraud and Misconduct by Frank Wells of Medic Legal Investigations. John Hall’s opening chapter, ‘The drug development process’ sets the tone for the rest of the book very effectively. The chapter is an excellent introduction to the world of drug discovery and development, balancing very effectively the commercial raison d’etre of the major pharmaceutical companies involved in drug discovery with the needs of the consumer, or rather the patient, the safety of whom must be the fundamental priority of all concerned. The myriad regulations surrounding Clinical Trials are well addressed in David Talbot and Joan Perou’s chapter on Ethical Issues which covers GCP, the Declaration of Helsinki (and subsequent revisions) and the thorny issue of informed consent. Subsequent chapters deal with Trial, Protocol and Case record form design along with investigator and outsourcing supplier selection, always with an eye to the practical implications of what is being written. The book is also remarkably forward thinking in it’s outlook, covering in detail the perpetually increasing demands of data management and archiving, liability and the implications of regulation of biotechnology products and medical devices. If there is one criticism, however, it would be of the relative lack of reference to the gradual harmonisation of clinical trials to allow new drugs to be accepted into all the major markets as quickly as possible, particularly with reference to the Japanese market, no doubt these revisions will be appearing in the near future. That minor criticism aside, it is impossible not to heartily endorse ‘The Principles of Clinical Research’ both as a companion for the experienced CRA, Project Manager or other Clinical Research professional or to the young graduate desperate to land their fist role with a CRO. The book doesn’t shy away from the aspects of the drug development process that can make us all uncomfortable but addresses all the topics it covers with a dispassionate and independent eye, never losing site of the fundamental reason behind the trial, the patient that needs help. Mark Stacey.

Mark Stacey

Last updated on: 27/08/2010 11:40:18

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