Quick Guide to Clinical Trials, 2nd Edition

A Quick Guide to Clinical Trials –  This book provides a unique view of the clinical trials process.

Appropriately designed and executed clinical trials are at the heart of the successful development of new medicines for patients. 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.

About the Contributors
Setting the scene
Chapter 1: Introduction: What’s in it for me: Why should I read this book?
Drs Madhu Davies and 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
Chapter 6: The Clinical Trials Process: Quality Management Systems
Dr Julie Meeson, PhD
Chapter 7: The Clinical Trials Process: Project Management
Mrs. Joy Dummer
Chapter 8: The Clinical Trials Process: Regulatory Affairs and Clinical Trials
Dr Faiz Kermani, PhD and Dr Madhu Davies
Chapter 9: The Clinical Trials Process: Study Monitoring
Dr Ignazio Di Giovanna, PhD and Dr Gareth Hayes, PhD
Chapter 10: The Clinical Trials Process: Statistics
Mrs Cathy O’Brien
Chapter 11: The Clinical Trials Process: What is Data Management?
Mrs Lisa Nash
Chapter 12: The Clinical Trials Process: Technology in Clinical Trials
Dr Bill Byrom, PhD
Chapter 13: The Clinical Trials Process: Clinical Trials and the role of Medical Writers
Dr Lisa Chamberlain James, PhD and Dr Julia Forjanic
Klapproth, PhD
Chapter 14: The Clinical Trials Process: Role of the clinical research physician
Dr Madhu Davies
Clinical Trials: Broadening the outlook
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
A quick guide to clinical trials >>>>> vii
Chapter 17: Clinical Trials in Resource-limited Settings
Dr Faiz Kermani, PhD
Chapter 18: The Future of Clinical Trials
Dr Faiz Kermani, PhD
Figures and Tables
Figure 5.1: 2012 Worldwide Active R&D Projects by Phase
Figure 5.2: “Decision gates”
Figure 6.1: Deming cycle
Figure 6.2: Typical Quality Risk Management Process
Figure 6.3: Example of an Organizational Chart
Figure 6.4: Example of a Typical Controlled Document Hierarchy
Figure 8.1: The Product Lifecycle
Figure 8.2: Regulatory Affairs Is Vital for All Stages of the Lifecycle of a Medicine
Figure 10.1: Cumulative Probability Plot for Height
Figure 10.2: Example Pharmaco kinetic Profile
Figure 10.3: Phases of Clinical Research
Figure 11.1: An Example of a Paper Data Management Process
Figure 11.2: An Example of an Electronic Data Management Process, With Electronic Data Capture (EDC)
Figure 11.3: Example Demography Screen on an Electronic Data Management System
Figure 11.4: Example of a Paper Demography Page
Figure 11.5: An example of the MedDRA hierarchy as demonstrated with a PT of headache
Figure 12.1: Automated Supply Chain Management Using IVR/IWR
Figure 12.2: Typical Workflow When Using an Electronic Data Capture System
Figure 12.3: Medical Imaging Solutions in Clinical Trials
Figure 12.4: Centralized Image Review
Figure 12.5: Example of Data Quality Issues with a Simple Paper Diary
Figure 12.6: Common ePRO Modalities
Figure 12.7: A typical Smartphone ePRO Solution: TrialMax Touch® device displaying a numeric rating scale for pain rating
Figure 13.1: Nomenclature for Study Reports
Figure 13.2: The CTR Production Process Involving a Strategic Medical Writer
Figure 13.3: The Role of the Medical Writer
Fig 18.1: Estimated Number of Industry-Sponsored Clinical Trials in the U.S. by Phase in 2013
Fig 18.2: Estimated Number of Trial Participants in Industry-Sponsored Clinical Trials in the U.S. by Phase in 2013
Fig 18.3: Prevalence of Diabetes
Table 2.1: Classification of Clinical Trials by Objective
Table 6.1: Requirements of a QMS per ISO9001:20154 and Examples
Table 8.1: T he Regulatory Affairs Profession Summarized at Four Stages
Table 8.2: I CH Discussion Topics
Table 8.3: FDA Meetings
Table 8.4: Routes for Authorizing Medicines in the EU
Table 8.5: Overview of FDA’s Expedited Programs for Serious Conditions
Table 9.1: Traditional Monitoring vs. Risk Based Monitoring
Table 9.2: The Monitoring Visit
Table 17.1: Project outline – Developing a Global Observatory for Health R&D
Table 18.1: Potential Benefits and Risks of Involvement in a Clinical Trial

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