Publications, Reports and Books
Why should I read this book?
Appropriately designed and executed clinical trials are at the heart of the successful development of new medicines for patients. This book provides a unique view of the clinical trials process. You will be able to see exactly how any given discipline fits in and plays its part in delivering the overall clinical trial program. The successful design, execution and delivery of an effective clinical trial program relies on excellent cooperation, understanding and respect within an often widely dispersed multi-disciplinary team. The chapters are jargon-lite but detailed enough to provide the framework onto which you, the reader, can attach that jargon when you are good and ready. Each chapter also stands alone as a ‘quick dip’ foundation or refresher. Everyone involved in clinical trials finds it demanding to keep up-to-date with current developments in the field. We believe you will come away with a really good basic grasp of the excitement of the clinical trials process, its drivers, checks and balances, and how you may even be able to contribute in a wide variety of ways.
Edited by Drs. Madhu Davies and Faiz Kermani.
Published by BioPlan Associates, Inc. April 2008
"Clinical trials are the single most resource-intensive investment in bringing a drug to market. Davies and Kermani have created a primer that should be essential reading for any healthcare professional and life scientist who want to understand this complex, billion-dollar process."
– Jane Chin, Ph.D. President, Medical Science Liaison Institute.
- "This book provides a broad overview of the complex issues involved in the design, conduct and oversight of clinical trials. The authors bring a 'hands-on' expertise and diversity of perspectives to the book. Clearly and simply written, the book will be especially useful for readers who are new to clinical trials regardless of their role, or for experienced readers who want to refresh their knowledge of aspects to which they are less frequently exposed." - Robert "Skip" Nelson, MD PhD, Pediatric Ethicist, Office of Pediatric Therapeutics, US Food and Drug Administration
- “As a job recruiter to this industry, I would strongly urge each and every candidate considering a career in clinical research to read this book. Armed with this knowledge and wisdom, they will have an advantage over others who have not read it.” – Austen Yapp, Founder & Director, Jobs.LeadDiscovery Ltd
- “An excellent resource. Chapters 5 and 6 will be invaluable for new starters working in pharma or contract research. Given the current surge in recruitment, this may assist with the challenge of training to GCP standards. Chapter 11 on technology will introduce or explain the rise in the use of electronic data solutions and will raise the issue of management of the vendors, while Chapter 12 will illustrate ways of finding patients and the challenges of retaining them in trials”. – Sian Hingston, Head of Clinical Resourcing, Global Clinical Operations Europe, GSK
- “This book covers the bases for anyone interested in clinical trials.” – Professor John Staniforth, CSO, PharmaKodex Ltd, UK
- “An excellent resource to demystify the world of clinical trials.” – Rod Richards, CEO PharmaKodex Ltd, UK
- “An excellent resource!” – Anil Vaidya, CEO, Iatro Medical Systems
- “As clinical trials become more complex, here’s a book that still manages to keep the subject simple.” – Andrea Palluch, Director, Inpharmedia
- “As a medical writer I found that this book provided an excellent overview of my specialization, but it also allowed me insight into other areas of clinical trials.” – Leigh van Wyk, Medical Writer
- "Whether you represent the sponsor or the CRO, this book is a must-read for anyone involved in understanding the latest developments in the clinical trial process." – Ronald R. Baker, Director of Business Development - North America, SGS Life Science Services
- “This book is a great teaching tool. Some of the chapters are priceless (such as "Clinical Trials and the Patient"), while others provide deep content on a multitude of subjects.” – Suzanne M. Sensabaugh, MS, MBA, Vice President Biopharmaceutical Development, MDS Pharma Services
- “An excellent book to add to your clinical trials library. There are books that deal with the theoretical aspects, and "cookbooks" that try to tell you exactly what to do. This book is special in that it adds a new element; it also tells you about clinical trials in a very practical way – what the job is about. This one adds a new, refreshing perspective and definitely belongs on your bookshelf.” – Steven E. Linberg, Ph.D., Managing Director, Chiesi Pharmaceuticals Inc.