Ruggieri Lucia, Bonifazi Donato, Landi Annalisa, Bonifazi Fedele, Bartoloni Franco, Costello Mary, Felisi Maria Grazia, Gasthuys Elke, Godo Anila, Martinon Torres Federico, Nadal David, Nuytinck Lieve, Rocchi Francesca, Turner Mark, Ceci Adriana
Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Bari, Italy.
Consorzio per Valutazioni Biologiche e Farmacologiche, Bari, Italy.
Acta Paediatr. 2020 Mar;109(3):607-612. doi: 10.1111/apa.15020. Epub 2019 Oct 13.
The European Network of Excellence for Paediatric Clinical Research, known as the TEDDY Network, carried out a survey to determine the capacity and competence of paediatric centres to perform research studies.
A cross-sectional, web-based pilot survey was conducted from October 2016 to April 2017 with paediatric clinical research centres in 11 countries: Albania, Austria, Belgium, Denmark, Iceland, Ireland, Italy, Norway, Spain, Switzerland and the United Kingdom. All were registered with the TEDDY Network database.
We approached 107 centres and 63 provided data on their experiences and expertise in paediatric clinical trials. Four groups of performance indicators were identified, referring to scientific experience, trial readiness, trial competence, regulatory issues, ethics and patients. Most centres were actively involved in paediatric clinical research: 53 centres (84.1%) had received funds for more than five paediatric studies in the last 5 years, and 42 (66.7%) had a specific clinical trial unit and dedicated study coordinators. We concluded that the European centres we studied had the capability and capacity to conduct paediatric trials, but there was still room for improvement, including enhanced collaboration.
This pilot survey demonstrated that there is potential for performing paediatric trials across Europe, but improvements are possible.
欧洲儿科临床研究卓越网络(即TEDDY网络)开展了一项调查,以确定儿科中心开展研究的能力和资质。
2016年10月至2017年4月,对阿尔巴尼亚、奥地利、比利时、丹麦、冰岛、爱尔兰、意大利、挪威、西班牙、瑞士和英国这11个国家的儿科临床研究中心进行了一项基于网络的横断面试点调查。所有中心均在TEDDY网络数据库中注册。
我们联系了107个中心,其中63个中心提供了其在儿科临床试验方面的经验和专业知识数据。确定了四组绩效指标,涉及科学经验、试验准备情况、试验能力、监管问题、伦理和患者。大多数中心积极参与儿科临床研究:53个中心(84.1%)在过去5年中获得了超过五项儿科研究的资金,42个中心(66.7%)设有专门的临床试验部门和专职研究协调员。我们得出结论,我们研究的欧洲中心有能力开展儿科试验,但仍有改进空间,包括加强合作。
这项试点调查表明,欧洲各地开展儿科试验具有潜力,但仍有改进的可能。