The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) is a network of research networks, investigators and centres with recognised expertise in performing clinical studies in children. Enpr-EMA main objective is to facilitate studies in order to increase availability of medicinal products authorised for use in the paediatric population. This goal is achieved by fostering high-quality, ethical research on the safety and efficacy of medicines for use in children and by helping with the recruitment of patients for clinical trials as well as by enabling collaboration between networks and stakeholders. TEDDY General Assembly, held on 14th January 2018 in Rome, has provided the occasion to discuss the role and the importance of Enpr-EMA in facilitating paediatric research, by means of its efforts in linking together existing networks, defining consistent and transparent quality standards, harmonizing clinical trial procedures, defining strategies for resolving major challenges and communicating with external stakeholders. The members of Enpr-EMA, in fact, share the same interests, therapeutic needs and common aims such as improving the methodology, design and feasibility of paediatric clinical studies, developing standardized and innovative methods and tools for monitoring as well as evaluating the efficiency, effectiveness, and safety of therapeutic interventions for children and increasing availability of high quality licensed paediatric medicines. The involved stakeholders are pharmaceutical industries, patients, parents and patients organisations, national competent authorities, Ethics Committees, CROs and hospital pharmacists. In occasion of the TEDDY General Assembly, the activities and the objectives of two Enpr-EMA working groups were presented: the Ethics Working Group and the Working Group on Clinical Trial Preparedness.
The first collaborative group deals with the dialogue and the interaction with Ethics Committees (ECs) and contributes to support the implementation of the Paediatric Regulation, with the view that these efforts will create a more favorable environment to speed up high quality Paediatric Research.
The mission of the working group on Clinical Trial Preparedness is to create a guidance document on trial preparedness. This is defined as the set of contributing factors, which could increase the ability to complete high quality clinical trials in a timely manner. The working group is committed in activities such as the review of the current regulatory guidances and academic publications in relation to the conduct of trials in the paediatric population to identify discussion on preparedness as well as the analysis of previous initiatives on paediatric clinical trials to identify existing valuable guidance on overcoming challenges.
Further information on Enpr-EMA working groups are available here.