Poor formulation information in published paediatric drug trials.

Standing, J.F., Khaki, Z.F. and Wong, I.C.K. (2005) Poor formulation information in published paediatric drug trials. Pediatrics, 116 (4). e559-e562. 10.1542/peds.2005-0327.

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DOI: 10.1542/peds.2005-0327


Objective. The International Conference on Harmonisation Steering Committee recommends that appropriate formulations be used in pediatric drug trials. However, a lack of formulation research and/or economic constraints means that appropriate formulations are not always used. It is important for investigators who report the results of pediatric drug trials to provide sufficient information on the formulation and method of administration to ensure that the results can be reproduced in other clinical studies (reliability) and, more important, implemented in clinical practice (validity). The objective of this study was to evaluate whether pediatric formulation information was adequately reported in recent published trials of oral medicines that included children who were younger than 12 years. Methods. Studies that were published between July 2002 and June 2004 in 10 highly cited journals (5 pediatric and 5 general medicine) were hand-searched and data were extracted independently by 2 reviewers according to a protocol. Papers that reported oral medication studies that included children who were younger than 12 years were classified as containing adequate, some, or no information on drug formulation. Results. Of 3992 papers reviewed, 76 fulfilled the inclusion criteria. Only 28 (37%) gave adequate information for the study to be reproduced accurately, and 20 (26%) did not state the formulation used. When the formulation was reported, only 37 (49%) studies used a pediatric formulation (liquid, chewable tablet, granules). No significant differences between pediatric and general medical journals were seen, and no single journal consistently met the criteria for adequate information. Conclusion. Highly cited journals seem to permit inadequate formulation information in pediatric drug trials that they publish, impairing their validity and reliability. Authors should provide full formulation information in all pediatric clinical trial reports.

Item Type:Article
Additional Information:Full text available electronically.
Uncontrolled Keywords:clinical trial;literature review; pediatrics; child (under 12 years; dosage forms; pharmaceutical preparations
Departments, units and centres:Department of Practice and Policy > Centre for Paediatric Pharmacy Research
ID Code:1482
Journal or Publication Title:Pediatrics
Deposited By:Library Staff
Deposited On:23 Mar 2010 15:37
Last Modified:13 Oct 2011 16:37


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