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Should paediatricians support the European Paediatric Clinical Trials Register?
  1. H M Sammons1,
  2. C Naylor1,
  3. I Choonara1,
  4. C Pandolfini2,
  5. M Bonati2
  1. 1Academic Division of Child Health, The Medical School, University of Nottingham, Derbyshire Children’s Hospital, Derby, UK
  2. 2Mario Negri Institute, Milan, Italy
  1. Correspondence to:
    Prof. I Choonara
    Academic Division of Child Health, The Medical School, University of Nottingham, Derbyshire Children’s Hospital, Uttoxeter Road, Derby DE22 3DT, UK; imti.choonaranottingham.ac.uk

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Ensuring its success will help improve the use of medicines in children

The importance of clinical trials in children in providing a scientific evidence base for drug therapy is accepted by health professionals, regulatory authorities, the pharmaceutical industry, and the parents of children. Legislation in the USA alongside government investment in research has resulted in a significant increase in paediatric clinical trials in North America.1 European legislation is currently being proposed that will provide a financial incentive to the pharmaceutical industry to study medicines in Europe. The proposal has been prepared by the European Commission following extensive consultation. Within the UK the establishment of a Medicines for Children Research Network will hopefully also ensure that more clinical trials are performed in paediatric patients of all ages.

REGISTRATION OF CLINICAL TRIALS

There is increasing recognition that as well as performing clinical trials, registration is essential.2,3 Many completed clinical trials are never published. A group of researchers in North America have studied the publication of clinical trials that had been presented as abstracts at the Society for Pediatric Research. They found that 28% of abstracts were subsequently not published.4 This however may have been an underestimate as they relied on the return of questionnaires from authors who had presented the abstracts. A British study of the publication rate following presentation at two national meetings found that 22% and 49% of the presentations were subsequently not …

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