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Arch Dis Child 2009;94:729-733 doi:10.1136/adc.2008.148494
  • Drug therapy
  • Review

Running an international paediatric non-commercial clinical trial

  1. J P Osborne1,2,
  2. F J K O’Callaghan3
  1. 1
    Royal United Hospital, Bath, UK
  2. 2
    School for Health, University of Bath, Bath, UK
  3. 3
    Faculty of Medicine and Dentistry, The University of Bristol, Bristol, UK
  1. Correspondence to John Osborne, Children's Centre, Royal United Hospital, Combe Park, Bath BA1 3NG, UK; mpsjpo{at}bath.ac.uk
  • Accepted 22 April 2009

Abstract

The current regulations for conducting non-commercial clinical trials in Europe are many and complex. These are explored from the perspective of a UK based non-commercial international clinical trial. The reasons for the difficulties encountered are discussed and suggestions made as to how best to overcome them. Improvements are suggested for our law makers and competent authorities. It is argued that the current regulatory environment could be considered unethical as it inhibits and delays research.

Footnotes

  • Competing interests No competing interests are declared other than the authors being responsible for running an international clinical trial – see www.iciss.org.uk.

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