Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board
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...
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| Format: | Article |
| Language: | English |
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BMC
2017-08-01
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| Series: | BMC Medical Research Methodology |
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| Online Access: | http://link.springer.com/article/10.1186/s12874-017-0395-4 |
| _version_ | 1818241821487136768 |
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| author | Isabelle Gautier Perrine Janiaud Nelly Rollet Nicolas André Michel Tsimaratos Catherine Cornu Salma Malik Stéphanie Gentile Behrouz Kassaï |
| author_facet | Isabelle Gautier Perrine Janiaud Nelly Rollet Nicolas André Michel Tsimaratos Catherine Cornu Salma Malik Stéphanie Gentile Behrouz Kassaï |
| author_sort | Isabelle Gautier |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-12T13:35:26Z |
| format | Article |
| id | doaj.art-2fd5f390fca6472f947028032398dd6d |
| institution | Directory Open Access Journal |
| issn | 1471-2288 |
| language | English |
| last_indexed | 2024-12-12T13:35:26Z |
| publishDate | 2017-08-01 |
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| series | BMC Medical Research Methodology |
| spelling | doaj.art-2fd5f390fca6472f947028032398dd6d2022-12-22T00:22:58ZengBMCBMC Medical Research Methodology1471-22882017-08-011711810.1186/s12874-017-0395-4Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review BoardIsabelle Gautier0Perrine Janiaud1Nelly Rollet2Nicolas André3Michel Tsimaratos4Catherine Cornu5Salma Malik6Stéphanie Gentile7Behrouz Kassaï8Centre d’investigation Clinique Pédiatrique, INSERM CIC 9502, Hôpital d’Enfants de la Timone, AP-HMEvolutive Biology and Biometric Laboratory UMR5558 CNRS, Université Claude Bernard Lyon 1Evolutive Biology and Biometric Laboratory UMR5558 CNRS, Université Claude Bernard Lyon 1Centre d’investigation Clinique Pédiatrique, INSERM CIC 9502, Hôpital d’Enfants de la Timone, AP-HMCentre d’investigation Clinique Pédiatrique, INSERM CIC 9502, Hôpital d’Enfants de la Timone, AP-HMEvolutive Biology and Biometric Laboratory UMR5558 CNRS, Université Claude Bernard Lyon 1Evolutive Biology and Biometric Laboratory UMR5558 CNRS, Université Claude Bernard Lyon 1EA3279 - Santé Publique: Maladies Chroniques et Qualité de Vie, Aix-Marseille UniversitéEvolutive Biology and Biometric Laboratory UMR5558 CNRS, Université Claude Bernard Lyon 1Abstract 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.http://link.springer.com/article/10.1186/s12874-017-0395-4European Pediatric RegulationInstitutional Review boardRandomized Clinical Trials |
| spellingShingle | Isabelle Gautier Perrine Janiaud Nelly Rollet Nicolas André Michel Tsimaratos Catherine Cornu Salma Malik Stéphanie Gentile Behrouz Kassaï Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board BMC Medical Research Methodology European Pediatric Regulation Institutional Review board Randomized Clinical Trials |
| title | Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board |
| title_full | Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board |
| title_fullStr | Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board |
| title_full_unstemmed | Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board |
| title_short | Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board |
| title_sort | trends in the number and the quality of trial protocols involving children submitted to a french institutional review board |
| topic | European Pediatric Regulation Institutional Review board Randomized Clinical Trials |
| url | http://link.springer.com/article/10.1186/s12874-017-0395-4 |
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