Clinical Research Manual - 7th Edition

Edited by David K Luscombe and Peter D Stonier
ISBN: 978-0-9956666-1-0 (Hb)
ISBN: 978-0-9956666-8-9 (eBook)

Introduction

In 21 chapters and over 500 pages this comprehensive manual provides detailed information for both beginners and experts on matters ranging from study design and pharmacokinetics though to recruitment, monitoring, registration - and indeed all the information required to run every phase of a clinical trial from drug discovery through to regulatory requirements. The editors have a wealth of experience between them in the teaching and practice of clinical research and have selected and reviewed each chapter to ensure completeness and relevance. The chapters are written by acknowledged experts from companies and organisations involved in every aspect of clinical research, each providing practical advice and information.

The 7th edition of the Clinical Research Manual includes six new chapters:

• Dosage Form Design
• Clinical Trials Organisation
• Product Registration in the UK and Europe
• Clinical Trials of Medicines in Children
• Clinical Trials of Medicines in the Elderly
• Using Patient-Reported Outcomes as Tools for Clinical Practice

Table of Contents

1. Drug Discovery
Charles JR Hedgecock, Uppsala University, Sweden
2. Planning International Drug Development
Laura Brown, TOPRA, UK
3. Dosage Form Design
Rodney Horder, Abbott International
4. Pharmacokinetics
Tarlochan Singh Gill, Medway University, UK
5. Study Design
Angela Stokes, INC Research, UK
6. Recruitment of Investigators
Jacqueline Karmel and Roy Shentall, Millenium Pharmaceuticals
7. Recruitment of Patients
Jane Baguley, Cornaxis Ltd, UK
8. Statistical Methods in Clinical Trials
Richard Kay. RK Statistics, UK
9. Clinical Trials Organization
Katie Wood, Consultant, USA
10. Quality Assurance and Clinical Research
Rita Hattemer-Apostel, Verdandi AG, Switzerland
11. Good Clinical Research Practice
Nicky Dodsworth, Premier Research, UK
12. Monitoring the Safety of Medicines
Ronald D Mann, Southampton University, UK
13. Clinical Trial Supplies
Sue Miles, PCI Pharma Services, UK
14. Product Registration in the UK and Europe
Ned Kilpatrick, Greengage Regulatory, Australia
15. Clinical Research and Trial Regulations in the USA
David Jefferys, Eisai Europe
16. Clinical Research and Trial Registration in Japan
David Jefferys, Eisai Europe
17. Ethical and Legal Aspects of Clinical Research
Arundel McDougall, Camilla Hoffman and Jo-Anne Powell, Ashurst, UK
18. Clinical Trial Report Writing
Janet Gough, Documentation, Systems and Training, USA
19. Clinical Trials of Medicines in Children
Karel Allegaert and John N Van Den Anker, European Society of Pediatric Research and European Society of Pediatric Pharmacology
20. Clinical Trials of Medicines in the Elderly
Assem el Baghdady, AlphaBeta Pharma, UK
21. Using Patient-Reported Outcomes as Tools for Clinical Practice: A New Paradigm
Benoit Arnould, Mapi, Lyon, France