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Article: Poor formulation information in published pediatric drug trials

TitlePoor formulation information in published pediatric drug trials
Authors
KeywordsChild (under 12 years)
Clinical trial
Dosage forms
Literature review
Pediatrics
Pharmaceutical preparations
Issue Date2005
PublisherAmerican Academy of Pediatrics. The Journal's web site is located at http://pediatrics.aappublications.org/
Citation
Pediatrics, 2005, v. 116 n. 4, p. e559-e562 How to Cite?
AbstractObjective. 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. Copyright © 2005 by the American Academy of Pediatrics.
Persistent Identifierhttp://hdl.handle.net/10722/132881
ISSN
2015 Impact Factor: 5.196
2015 SCImago Journal Rankings: 3.226
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorStanding, JFen_HK
dc.contributor.authorKhaki, ZFen_HK
dc.contributor.authorWong, ICKen_HK
dc.date.accessioned2011-04-04T07:57:46Z-
dc.date.available2011-04-04T07:57:46Z-
dc.date.issued2005en_HK
dc.identifier.citationPediatrics, 2005, v. 116 n. 4, p. e559-e562en_HK
dc.identifier.issn0031-4005en_HK
dc.identifier.urihttp://hdl.handle.net/10722/132881-
dc.description.abstractObjective. 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. Copyright © 2005 by the American Academy of Pediatrics.en_HK
dc.languageengen_US
dc.publisherAmerican Academy of Pediatrics. The Journal's web site is located at http://pediatrics.aappublications.org/en_HK
dc.relation.ispartofPediatricsen_HK
dc.subjectChild (under 12 years)en_HK
dc.subjectClinical trialen_HK
dc.subjectDosage formsen_HK
dc.subjectLiterature reviewen_HK
dc.subjectPediatricsen_HK
dc.subjectPharmaceutical preparationsen_HK
dc.titlePoor formulation information in published pediatric drug trialsen_HK
dc.typeArticleen_HK
dc.identifier.emailWong, ICK: wongick@hku.hken_HK
dc.identifier.authorityWong, ICK=rp01480en_HK
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1542/peds.2005-0327en_HK
dc.identifier.pmid16199684-
dc.identifier.scopuseid_2-s2.0-33644682179en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-33644682179&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume116en_HK
dc.identifier.issue4en_HK
dc.identifier.spagee559en_HK
dc.identifier.epagee562en_HK
dc.identifier.isiWOS:000232289700066-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridStanding, JF=8702431000en_HK
dc.identifier.scopusauthoridKhaki, ZF=12766057000en_HK
dc.identifier.scopusauthoridWong, ICK=7102513915en_HK

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