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A quick guide™ to clinical trials “for people who may not know it all”

A quick guide™ to clinical trials “ for people who may not know it all”

Clinical Trials Textbook

Chapter End Summaries, Discussion Questions, Teachers’

Guide, and more!

“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. This 2nd edition, edited and written by Dr. Madhu Davies and Dr. Faiz Kermani, has been extensively revised to include additional topics and new subject matter experts to increase the breadth of discussion of this fascinating discipline. Each chapter stands alone as a ‘quick dip’ foundation or refresher.

Chapters are written by industry experts, carefully chosen for their abilities to clarify complex topics and make them interesting for everyone. Clinical trials that are well designed and appropriately executed are at the heart of the successful development of all new medicines. This edition continues to demystify the topic in an exceptionally reader-friendly, yet authoritative format.


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
A quick guide to clinical trials
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... 181
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..261
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
Glossary
Figures and Tables
Figure 5.1: 2012 Worldwide Active R&D Projects by Phase
Figure 5.2: “Decision gates”
Figure 5.3: “Go/No Go Decision Making”
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 Pharmacokinetic 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 RTSM
Figure 12.2: Typical Workflow When Using an Electronic Data Capture System...225
Figure 12.3: Medical Imaging Solutions in Clinical Trials
Figure 12.4: Centralized Image Review A quick guide to clinical trials
Figure 12.5: Example of Data Quality Issues with a Simple Paper Diary...230
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 12.8: Example SMS reminder system: the mPAL patient phone and site interface reproduced with permission of mProve Health...236
Figure 12.9: Continuous streams of activity data collected using an Actigraph accelerometer
Figure 13.1: Nomenclature for Study Reports
Figure 13.2: The CTR Production Process Involving a Strategic Medical Writer..254
Figure 13.3: The Role of the Medical Writer
Figure 18.1: Estimated Number of Industry-Sponsored Clinical Trials in the U.S. by Phase in 2013
Figure 18.2: Estimated Number of Trial Participants in Industry-Sponsored Clinical Trials in the U.S. by Phase in 2013
Figure 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: The 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..157
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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