Chapter 38. Clinical Trials in Paediatrics

  1. David Machin2,3,4,
  2. Simon Day5 and
  3. Sylvan Green6
  1. Johan P. E. Karlberg

Published Online: 17 MAY 2007

DOI: 10.1002/9780470010167.ch38

Textbook of Clinical Trials, Second Edition

Textbook of Clinical Trials, Second Edition

How to Cite

Karlberg, J. P. E. (2006) 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

  1. 2

    Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 16910, Singapore

  2. 3

    UK Children's Cancer Study Group, University of Leicester, UK

  3. 4

    Medical Statistics Group, School of Health and Related Sciences, University of Sheffield, UK

  4. 5

    Licensing Division, Medicines and Healthcare products Regulatory Agency, Room 13–205 Market Towers, 1 Nine Elms Lane, London SW8 5NQ, UK

  5. 6

    Arizona Cancer Centre, Tucson, Arizona, USA

Author Information

  1. Clinical Trials Centre, Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, PR China

Publication History

  1. Published Online: 17 MAY 2007
  2. Published Print: 24 NOV 2006

ISBN Information

Print ISBN: 9780470010143

Online ISBN: 9780470010167



  • 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


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