Bookworm's Pick: “A Quick Guide to Clinical Trials”

A properly designed clinical trial forms an integral part of successful drug development. However, to design and execute an effective clinical trial requires cooperation, understanding and respect of a multi-disciplinary team. The book, “A Quick Guide to Clinical Trials” explores the very essentials of clinical trials to lead the reader into the exciting arena.

Aimed at imparting a solid foundation of the clinical trials process, its drivers, checks and balances and more, this book sets out to deliver a unique view of clinical trial process, and how the reader can contribute to it? Inspired by young recruits to the pharmaceutical industry, it follows a jargon-lite style of presentation, the chapters however, are comprehensive enough for you to conceptualize a framework, which you can build upon later to include as many jargons as you please.

Further, as the book is appreciative of how challenging it can sometimes be for professionals to maintain currency of knowledge as it is generated, each chapter serves as a quick review of the clinical trials process, its drivers, checks and balances, etc. even for those who've matured in the industry.

The 14 chapters of the book have been classified in to 3 sections, namely broad overview, nuts and bolts, and the future.

1. The Broad Overview explains the significance of clinical trials, covers a short history of the FDA and clinical trials, and delves into the business aspect of pharmaceutical drug development.
2. The Nuts And Bolts section provides a comprehensive coverage of various aspects of clinical trial processes. It includes the following topics: project management, ethics in clinical research, regulatory affairs, monitoring, statistics, data management, technology in clinical trials, medical writing, the clinical research physician, and clinical trials vis-a-vis the patient.
3. The Future segment discusses the projections about the forthcoming outlook of the field, and is aptly titled “the future of clinical trials.”

The chapters of the book have been logically sequenced to move the reader gently from simple to complex. Moreover it stands out as an authoritative resource as the each of the chapters have been composed by experts and experienced clinical researchers from associated disciplines to portray the their professional roles, and to explain how they fit “into a very exciting big picture, overall.”

Carrying the catchphrase “for people who may not know it all,” the book verily addresses the growing need to understand clinical trials, as their importance has recently been highlighted by the recent events such as the “Sentinel Initiative” of the FDA, recall of drugs such as “Vioxx,” and reports of poor measurements for assessing clinical trials with children.

Key Details: Title: A Quick Guide to Clinical Trials for People Who May Not Know It All
Edited By: Drs. Madhu Davies and Faiz Kermani.
Published By: BioPlan Associates, Inc. April 2008
ISBN: 978-1-934106-08-2
Book URL: A Quick Guide to Clinical Trials

On the whole the book should serve as a single point resource to educate, appraise and refresh the reader about the world of clinical trials, in an intriguing and eloquent manner.