Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study

PLoS Medicine
Thomas J HwangFlorence T Bourgeois

Abstract

Few medicines have been approved for children, leading to rates of off-label prescribing reported to be as high as 90%. In 2007, the European Union adopted the Paediatric Regulation, which mandates that pharmaceutical companies conduct paediatric studies for all new medicines, unless granted a waiver. We aimed to evaluate the availability of paediatric trial results from studies required under the Paediatric Regulation for new medicines authorised in the EU. The European Medicines Agency (EMA) public database of paediatric investigation plans was searched for new medicines centrally authorised in the EU between 1 January 2010 and 31 December 2014 with at least 1 required paediatric study. For our study cohort of paediatric clinical trials required for these medicines, we used internal EMA databases and publicly available trial registries to determine changes to the planned completion date or study design, rates of trial completion, time to trial completion, and results reporting (peer-reviewed publication or posting on trial registry). Cox proportional hazards regression models were constructed to examine factors associated with study completion. A total of 326 paediatric clinical trials were required for 122 novel medicines au...Continue Reading

References

Sep 14, 2006·JAMA : the Journal of the American Medical Association·Daniel K BenjaminJennifer S Li
Dec 10, 2009·Archives of Pediatrics & Adolescent Medicine·Daniel K BenjaminJennifer S Li
Jul 25, 2012·Pediatrics·Florence T BourgeoisKenneth D Mandl
Jul 11, 2013·JAMA : the Journal of the American Medical Association·Kevin FainG Caleb Alexander
Mar 19, 2016·British Journal of Clinical Pharmacology·Jarno HoekmanMarie L De Bruin
Jan 24, 2017·JAMA : the Journal of the American Medical Association·Florence T Bourgeois, Thomas J Hwang
Jul 5, 2017·Therapeutic Innovation & Regulatory Science·Dobromir PenkovJean Temeck
Sep 21, 2017·The New England Journal of Medicine·Steven WoloshinThomas J Moore
Nov 18, 2017·Pharmacoepidemiology and Drug Safety·Joel D HudginsFlorence T Bourgeois

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Citations

Nov 8, 2018·British Journal of Clinical Pharmacology·Cécile OllivierLynne Yao
May 16, 2019·Therapeutic Innovation & Regulatory Science·Margaret Gamalo-SiebersRonald Portman
Oct 7, 2020·Journal of Biopharmaceutical Statistics·Matthew A Psioda, Xiaoqiang Xue
Dec 29, 2020·Journal of Clinical Pharmacology·Klaus RoseDavid Neubauer
Dec 6, 2020·Pharmaceutics·Bethany Faulkner, M Begoña Delgado-Charro
Apr 2, 2020·Seminars in Oncology·Ajay MajorSamuel L Volchenboum
Sep 19, 2019·Pediatrics·Divya HoonDaniel B Horton

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