Centre d'investigation Clinique Pédiatrique, INSERM CIC 9502, Hôpital d'Enfants de la Timone, AP-HM, 264, rue Saint-Pierre, 13005, Marseille, France.
EA3279 - Santé Publique: Maladies Chroniques et Qualité de Vie, Aix-Marseille Université, 13385, Marseille, France.
BMC Med Res Methodol. 2017 Aug 23;17(1):130. doi: 10.1186/s12874-017-0395-4.
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.
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.
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.
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.
儿童非常需要高质量的临床研究。欧洲儿科法规旨在提高临床试验的质量，以便为儿童提供更多的治疗方法。本研究的主要目的是评估在欧盟儿科法规启动前后，向法国机构审查委员会（IRB00009118）提交的儿科试验方案的数量和质量的演变。
所有在 2003 年至 2014 年间提交给 IRB00009118 并针对十八岁以下受试者进行研究的方案都符合条件。根据增强健康研究质量和透明度（EQUATOR）网络制定的指南评估随机临床试验的质量，并使用 Jadad 评分进行排名。
在提交给机构审查委员会（IRB）的 622 项方案中，有 21%（133/622）包括儿童。在这 133 项儿科方案中，提交的儿科方案数量在两个研究期间翻了一番。2003 年至 2008 年期间，向 IRB 提交了 47 项方案，其中 21 项由机构赞助；2009 年至 2014 年期间，提交了 86 项方案，其中 48 项由机构赞助。未观察到 RCT 质量的显著趋势。Jadad 量表上 RCT 的总体中位数评分为高（3.5），70.0%的方案得分为≥3，30.0%的方案得分为<3。
在欧盟儿科法规之后，向 IRB00009118 提交的儿科方案数量呈上升趋势，但质量没有变化。
