“A Quick Guide to Clinical Trials”, 2nd ed. allows readers, both academic and professional, to get a firm grip on the topic, with just enough detail to ensure a comprehensive understanding. Each chapter also stands alone as a ‘quick dip’ foundation or refresher. The chapters in this book are written by industry experts, carefully chosen for their abilities to clarify complex topics and make them interesting for everyone.
As a textbook resource, students receive chapter-end summaries, and discussion questions; as a refresher for those already in the field, you will receive updated, easy-to-read content that’s far more than a basic overview!
Edited by Drs. Madhu Davies and Faiz Kermani
Published: BioPlan Associates, Inc., October 2016
Download PDF Brochure [PDF 498k]
Table of Contents
Setting the scene
Chapter 1: Introduction: What’s in it for me: Why should I read this book?
Drs Madhu Davies, Faiz Kermani, PhD
Chapter 2: Why Do We Do Clinical Trials?
Dr Graham Wylie
Chapter 3: FDA and Clinical Drug Trials: A Short History
Dr Suzanne Junod, PhD
Chapter 4: Primer on Ethics in Clinical Research
Dr Harris Dalrymple, PhD
Chapter 5: The Business of Successful Drug Development
Dr Todd Johnson, MD
Nuts and bolts- The Clinical Trials Process
Chapter 6: Quality Management Systems
Dr Julie Meeson, PhD
Chapter 7: Project Management
Mrs. Joy Dummer
Chapter 8: Regulatory Affairs & Clinical Trials
Drs Faiz Kermani, PhD, Madhu Davies
Chapter 9: Study Monitoring
Drs Ignazio Di Giovanna, PhD, Gareth Hayes, PhD
Chapter 10: Statistics
Mrs Cathy O’Brien
Chapter 11: What is Data Management?
Mrs Lisa Nash
Chapter 12: Technology in Clinical Trials
Dr Bill Byrom, PhD
Chapter 13: Clinical Trials and the role of Medical Writers
Drs Lisa Chamberlain James, PhD, Julia Forjanic Klapproth, PhD
Chapter 14: Role of the clinical research physician
Dr Madhu Davies
Chapter 15: Clinical Trials and the Patient: Why Does a patient join a clinical trial?
Mrs Elizabeth Langley
Chapter 16: Clinical Development Guide to Japan
Dr Hajimu Morioka, PhD
Chapter 17: Clinical Trials in Resource-limited Settings
Dr Faiz Kermani, PhD
Chapter 18: The Future of Clinical Trials
Dr Faiz Kermani, PhD
By the Numbers
- 340 pages
- 18 Chapters
- Every chapter includes Summary Chapter Key Ideas and Discussion Questions
- 1 Instructors’ guide is available
Reviews and Quotes:
- “A Quick Guide to Clinical Trials is an excellent overview of the clinical trial process and drug development from an international perspective.” – Steven E. Linberg, PhD, Adjunct Graduate Faculty, Johns Hopkins University; Founder, S.E. Linberg Consulting, LLC.
- “This book is a well-presented, quick reference guide covering a broad range of important and relevant clinical trial-related topics….” – Dr. Ernest A. Kopecky, VP, Clinical Development; Head, Neuroscience, Collegium Pharmaceutical, Inc.
- “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 invaluable guide to navigate the complexities of clinical drug development.” – Leigh van Wyk, Director of Learning Strategy, Medical Education, Ogilvy Healthworld
- “Having led a Federal Agency with a ‘science to service’ mission, I found this book to be a straightforward and comprehensive guide to understanding the essential elements of clinical trials.”– Charles G. Curie, Principal, The Curie Group, LLC
- “As clinical trials become more complex, this book still manages to keep the subject simple. If you are an investigator in academia conducting your own clinical trials, starting a career in the pharmaceutical industry, or one of the companies providing services to the pharmaceutical industry, this book is a must for you.” – Prof. Michael Davidson, Professor of Psychiatry, Sackler School of Medicine
- “This book is a readable, comprehensive primer on clinical trials that conveys their basic fundamentals as well as their excitement and challenges.” – Dr. Larry Alphs, Therapeutic Area Leader, Psychiatry, Janssen
- “In our globally connected world, clinical trials remain the nexus of scientific exchange within the medical science community. Davies and Kermani have updated this essential primer to include a global perspective to this complex, resource-intensive process.” – Jane Chin, Ph.D. Founder, Medical Science Liaison Institute
- “You are in safe hands once you open this book. The updated edition takes a new starter or even seasoned clinical research professional through the “what to do and why” scenarios very comprehensively. The regulatory advice will help project teams to understand why they are being asked to perform certain tasks or why a protocol collects certain data that could be challenging. The chapter on Japan is highly recommended – as knowing where to start and how to make a trial work there can be so difficult to navigate. Also good to see the ePRO is included and updated, given how much the industry will lean on this in future. – Sian Hingston, Project Management Professional, PPD