1. Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board
- Author
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Nicolas André, Stéphanie Gentile, Nelly Rollet, Behrouz Kassai, Catherine Cornu, Michel Tsimaratos, Perrine Janiaud, Salma Malik, Isabelle Gautier, Centre d'Investigation Clinique Pédiatrique [Marseille], Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital d'Enfants de la Timone [Marseille], Assistance Publique - Hôpitaux de Marseille (APHM)-Assistance Publique - Hôpitaux de Marseille (APHM), Santé Publique et maladies Chroniques : Qualité de vie Concepts, Usages et Limites, Déterminants (SPMC), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM), Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Épidémiologie, Pharmacologie, Investigation Clinique et Information médicale, Mère-Enfant [Bron] (EPICIME), Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital d'Enfants de la Timone [Marseille], Assistance Publique - Hôpitaux de Marseille (APHM)-Assistance Publique - Hôpitaux de Marseille (APHM)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Bodescot, Myriam
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Adult ,Male ,medicine.medical_specialty ,Pediatrics ,Adolescent ,Epidemiology ,media_common.quotation_subject ,Trial protocol ,Alternative medicine ,Health Informatics ,law.invention ,Young Adult ,03 medical and health sciences ,[SDV.MHEP.PED] Life Sciences [q-bio]/Human health and pathology/Pediatrics ,0302 clinical medicine ,Clinical Protocols ,Randomized controlled trial ,law ,030225 pediatrics ,medicine ,Humans ,Quality (business) ,030212 general & internal medicine ,European Pediatric Regulation ,Child ,Institutional Review board ,media_common ,Clinical Trials as Topic ,lcsh:R5-920 ,[SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics ,business.industry ,Institutional review board ,Jadad scale ,3. Good health ,Clinical trial ,Clinical research ,Randomized Clinical Trials ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,Family medicine ,Female ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,France ,lcsh:Medicine (General) ,business ,Research Article ,Ethics Committees, Research - Abstract
International audience; 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.
- Published
- 2017