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BMC Medical Research Methodology
Published in: BMC Medical Research Methodology 1/2017

Open Access 01-12-2017 | Research article

Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board

Authors: Isabelle Gautier, Perrine Janiaud, Nelly Rollet, Nicolas André, Michel Tsimaratos, Catherine Cornu, Salma Malik, Stéphanie Gentile, Behrouz Kassaï

Published in: BMC Medical Research Methodology | Issue 1/2017

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Abstract

Background

There is a great need for high quality clinical research for children. The European Pediatric Regulation aimed to improve the quality of clinical trials in order to increase the availability of treatments for children. The main purpose of this study was to assess the evolution of both the number and the quality of pediatric trial protocols that were submitted to a French Institutional Review Board (IRB00009118) before and after the initiation of the EU Pediatric Regulation.

Methods

All protocols submitted to the IRB00009118 between 2003 and 2014 and conducting research on subjects under eighteen years of age were eligible. The quality of randomized clinical trials was assessed according to the guidelines developed by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network and ranked using the Jadad score.

Results

Out of 622 protocols submitted to the Institutional Review Board (IRB), 21% (133/622) included children. Among these 133 pediatric protocols, the number of submitted pediatric protocols doubled between the two studied periods. From 2003 to 2008, 47 protocols including 21 institutionally sponsored were submitted to the IRB and from 2009 until 2014, 86 protocols including 48 institutionally sponsored were submitted. No significant trend was observed on the quality of RCTs. The overall median score of RCTs on the Jadad scale was high (3.5), 70.0% of protocols had a Jadad score ≥ 3, and 30.0% had a score < 3.

Conclusion

Following the EU Pediatric Regulation, the number of pediatric protocols submitted to the IRB00009118 tends to increase, but no change was noticed regarding their quality.
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Metadata
Title
Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board
Authors
Isabelle Gautier
Perrine Janiaud
Nelly Rollet
Nicolas André
Michel Tsimaratos
Catherine Cornu
Salma Malik
Stéphanie Gentile
Behrouz Kassaï
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Medical Research Methodology / Issue 1/2017
Electronic ISSN: 1471-2288
DOI
https://doi.org/10.1186/s12874-017-0395-4

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