Defining quality standards and accreditation processes will be the first priority of the EU-wide paediatric research network foreseen in the new regulation on medicinal products for paediatric use.
Further priorities will be agreed by a Steering Committee envisaged as part of the implementation programme for the paediatric network once it is launched next year. These and related proposals have been put out for public consultation by the European Medicines Agency (EMEA) in a draft implementing strategy for the EU network of paediatric investigators and trial centres.
Article 44 of the paediatric regulation (No. 1901/2006) stipulates that the EMEA “shall, with the scientific support of [its] Paediatric Committee, develop a European network of existing national and European networks, investigators and centres with specific expertise in the performance of studies in the paediatric population.”
Among the objectives of this network, the regulation adds, will be “to co-ordinate studies relating to paediatric medicinal products, to build up the necessary scientific and administrative competences at European level, and to avoid duplication of studies and testing in children.”
As the draft implementing strategy notes, the intention is not that the EU network should itself conduct clinical trials, fund research or decide on areas of paediatric research. The last of these responsibilities lies with individual networks, the Member States or the European Commission through Community programmes.
A light touch
The EMEA also envisages a ‘light-touch’ organisation, with the agency acting as a facilitator and service provider. “The main concern is to avoid creating a resource-intensive structure replicating existing bodies and generating potential overlap of activities and responsibilities,” the implementing strategy comments. “The network’s human and financial resources should remain extremely limited.”
In this spirit, the EMEA proposes establishing a steering committee at the agency that would contribute to the short- and long-term strategy for the network, discuss and resolve operational and scientific issues, report to the Paediatric Committee, and act as a forum for communication.
Membership of the committee, the draft strategy says, should include one representative per accredited (national or European) paediatric network, three members of the EMEA’s Paediatric Committee, one representative of the European Commission’s Directorate General for Research, two EMEA representatives and additional members according to the specific expertise required (eg. from patient groups or ethics committees).
The Steering Committee should forge strong links with the Heads of Medicines Agencies’ Clinical Trials Facilitation Group, in order to “develop a common understanding and improvement of processes,” the EMEA adds.
Goals set out
The draft strategy also sets out more detailed goals for the network, under the headings of collaboration, building competences, avoiding unnecessary studies, stimulating high-quality research, strengthening the foundation of the European Research Area, and facilitating recruitment for clinical trials. These goals include:
- Identifying, co-ordinating and linking together existing paediatric networks;
- Providing a forum for scientific discussions with stakeholders on paediatric clinical trials;
- Defining scientific and operational quality standards, as well as accreditation criteria, for the network that are not covered by existing standards (eg. Good Clinical Practice);
- Stimulating research and education on trial methodologies;
- Sharing information with European and international partners, particularly through the EU’s EudraCT database, to avoid duplication of clinical trials in children;
- Raising awareness of the need for paediatric trials;
- Supporting the identification of research priorities for off-patent medicines; and
- Enabling rapid attainment of sample sizes that are large enough to support valid conclusions in paediatric trials;
As the draft implementing strategy points out, there are already a number of paediatric networks either up and running or under construction in the European Union.
Among these are seven identified national networks, publicly funded European networks such as the Task Force in Europe for Drug Development of the Young (TEDDY), paediatric ‘sub-speciality’ networks in therapeutic areas such as HIV infection, activity- or structure-related networks (eg. community practitioner networks), and networks including paediatric centres but not dedicated solely to paediatric research.
The public consultation on the draft strategy runs until 20 August, after which the proposals will go to the EMEA’s Paediatric Committee.