Chapter 38. Clinical Trials in Paediatrics
- David Machin2,3,4,
- Simon Day5,
- Sylvan Green6
Published Online: 17 MAY 2007
DOI: 10.1002/9780470010167.ch38
Copyright © 2006 John Wiley & Sons, Ltd
Book Title
Textbook of Clinical Trials, Second Edition
Additional Information
How to Cite
Karlberg, J. P. E. (2007) Clinical Trials in Paediatrics, in Textbook of Clinical Trials, Second Edition (eds D. Machin, S. Day and S. Green), John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470010167.ch38
Editor Information
- 2
Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 16910, Singapore
- 3
UK Children's Cancer Study Group, University of Leicester, UK
- 4
Medical Statistics Group, School of Health and Related Sciences, University of Sheffield, UK
- 5
Licensing Division, Medicines and Healthcare products Regulatory Agency, Room 13–205 Market Towers, 1 Nine Elms Lane, London SW8 5NQ, UK
- 6
Arizona Cancer Centre, Tucson, Arizona, USA
Publication History
- Published Online: 17 MAY 2007
- Published Print: 24 NOV 2006
ISBN Information
Print ISBN: 9780470010143
Online ISBN: 9780470010167
- Summary
- Chapter
Keywords:
- clinical trials in paediatrics;
- E11 ICH Guideline - clinical trials in paediatric populations;
- ethical considerations in paediatric studies;
- paediatric informed consent;
- pharmacokinetics and pharmacodynamics of drugs in children and in adults
Summary
This chapter contains sections titled:
Why should we do Clinical Trials in Children?
Regulatory Issues of Clinical Trials in Children
Post-Launching the ICH Guideline E11
Ethical Considerations in Paediatric Studies
Specific Problems of Paediatric Studies
Final Comments
Further Reading