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Joined-up Thinking

 

Article 44 of the 2006 Paediatric Regulation of the European Parliament required the European Medicines Agency (EMA) to develop a European network linking existing national and European networks, investigators and centres with specific expertise in performing studies in the paediatric population (1). To meet this objective the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) has been established and was launched and presented to stakeholders in March 2011.

Establishing the Network

The first task was to establish an inventory of existing paediatric networks, investigators and centres with specific expertise in conducting studies in the paediatric population. Interested stakeholders were identifed, including patients, parents, families and support organisations, paediatric and other relevant societies, national competent authorities, ethics committee representatives, paediatric healthcare providers, the pharmaceutical industry, clinical research organisations and hospital pharmacists. The goals of the network are detailed in the implementation strategy adopted by the management board at EMA in January 2008.

Operational Structure and Development of Policies

Two working groups made up of members of existing European research networks were given the tasks of developing the operational structure of Enpr-EMA and the recognition criteria for membership of Enpr-EMA. These tasks were completed in February 2010 and were agreed at a subsequent workshop attended by representatives of all identified networks. In addition to agreeing these policies and recognition criteria, a co-ordinating group (CG) was established during the following year. Although it was agreed that the pharmaceutical industry should not be directly represented on the CG, the importance of regular communication with the industry was established. The main tasks of the CG were identified as follows:

  • To facilitate pharmaceutical industry access to paediatric clinical study centres and experts
  • To discuss and resolve operational and scientific issues
  • To act as a forum for communication; to identify new and emerging networks, inviting them to apply for Enpr-EMA membership
  • To develop common educational tools for children and parents and encourage their participation in clinical trials
  • To liaise with the Paediatric Committee of the EMA (PDCO)

Enpr-EMA Recognition Criteria

A set of recognition criteria and quality standards were developed using the Delphi and nominal group techniques (2). Six quality criteria were identified: research experience and ability; network organisation and processes; scientific competencies and ability to provide expert advice; quality management; training and educational capacity to build competences; and public involvement. From this list a minimum set of criteria for Enpr-EMA recognition was agreed at the workshop in 2010. Networks submitting their selfassessment reports are expected to provide evidence in support of any claims and these are reviewed by the EMA secretariat and published on the EMA website. All self-assessment reports have to be annually revised and updated.

Following a call for expressions of interest in 2010, 34 networks have submitted selfassessment reports to the EMA. Following review by the EMA secretariat, networks were classified according to three predefined categories depending on their ability to meet the membership criteria.

Milestones Achieved

On the first day of the launch meeting, open to networks only, Enpr-EMA’s co-ordinating group was established with election of Enpr-EMA’s first co-chairs (Peter Helms and Irmgard Eichler). Priority tasks for the CG were identified as: establishing Enpr- EMA as a platform for communication with industry and patient organisations; linking activities between Enpr-EMA’s members; developing common educational tools for patients/parents to increase willingness to participate in paediatric trials; collaborating with the PDCO on the development of ‘model’ paediatric investigation plans (PIPs) in selected therapeutic areas; and defining a policy of transparency in line with the EMA policy on the handling of conflicts of interest.

Current tasks supported by the CG and EMA secretariat are the development of model PIPs, identifying and fostering emerging networks, improving interactions with patient/parent representatives and organisations, establishing a communication strategy and dealing with industry queries. As far as this latter area is concerned, the maintenance of confidentiality of information submitted to Enpr-EMA by industry will be one of the major topics in the upcoming workshop in March 2012.

Conclusion Enpr-EMA is now well established and even though more work is needed, the way ahead for Enpr-EMA is clear. Enpr-EMA aims to become the platform for access to competent, high quality networks with recognised expertise in performing clinical studies in children across Europe. Enpr-EMA anticipates an ever increasing pool of key players and networks with capacity to conduct paediatric drug trials to provide timely and well-informed scientific advice, and to act as advocates for the needs of children as far as the safe and effective use of medicines is concerned.

Disclaimer

The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.

References

  1. 1. Regulation (EC) no 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union 2006;L 378:1-19
  2. 2. Ruperto N, Eichler I, Herold R et al, A European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), Arch Dis Child published online November 27, 2011 doi: 10.1136/archdischild-2011-300286

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The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) is an association of research networks, investigators and centres with recognised expertise in performing clinical trials in the paediatric population. Enpr-EMA represents a wide range of therapeutic areas and relevant methodologies across the entire paediatric age range, from newborns to adolescents, and aims to foster highquality ethical research on the quality, safety and efficacy of medicines to be used in children. It achieves this through networking and stakeholder collaboration with members from within and outside the European Union (EU). For more information please visit the EMA website, http://www.ema.europa.eu/

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