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Inappropriate oral formulations and information in paediatric trials
  1. Sreenivas Pandit2,
  2. Utpal Shah3,
  3. Daniel Jon Kirby4,
  4. Tony Nunn5,
  5. Catherine Tuleu1
  1. 1Department of Pharmaceutics and Centre for Paediatric Pharmacy Research, The School of Pharmacy, University of London, London, UK
  2. 2Centre for Paediatric Pharmacy Research, The School of Pharmacy, University of London, London, UK
  3. 3Alder Hey Children's NHS Foundation Trust and School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK
  4. 4Medicines Research Unit, School of Life and Health Sciences, Aston University, Birmingham, UK
  5. 5Alder Hey Children's NHS Foundation Trust and NIHR Medicines for Children Research Network, Liverpool, UK
  1. Correspondence to Dr Catherine Tuleu, Department of Pharmaceutics and Centre for Paediatric Pharmacy Research, The School of Pharmacy, University of London, 29/39 Brunswick Square, London WC1N 1AX UK; catherine.tuleu{at}pharmacy.ac.uk

Abstract

Previously, quality of formulations information provided for oral medications used in paediatric clinical trials published in 10 highly cited journals between 2002 and 2004 raised concerns. This short report explores if there was any subsequent improvement on how the formulations used in trials involving children <12 years reported in the same journals. Studies published between 2004 and 2008 were hand-searched and classified as containing adequate, some or no formulation information. Those involving solid dosage forms were further analysed. Only 31% (44/140) of publications provided adequate information, 5% less compared to 2002–2004 (28/76). There was a significant 12% rise (p<0.05) of no formulation information at all (37/140) and in tablets/capsules use (53/140), of which 3/4 gave no administration details, even for those under 6 years old, but a 12% decline in suitable paediatric formulations use (52/140 compared to 37/76). Contrary to expectations, overall quality of formulation information reported markedly deteriorated, jeopardising validity of clinical outcomes. The situation may reflect continued lack of awareness among investigators and other stakeholders of the importance of using suitable age-appropriate formulations.

  • Accepted 19 April 2010

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  • Accepted 19 April 2010
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Footnotes

  • Funding NIHR MCRN.

  • Competing interests None.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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