TOPIC : Creation of a pan-European Paediatric Clinical Trials Network

Topic identifier: IMI2-2016-10-04
Publication date: 21 December 2016

Types of action: IMI2-RIA Research and Innovation action
Opening date:
04 January 2017
2nd stage Deadline:
28 March 2017 17:00:00
14 September 2017 17:00:00

Time Zone : (Brussels time)
Topic Description

Specific Challenge:Publications have previously shown that only 30% of marketed drugs in Europe and worldwide include a paediatric authorisation and less than 50% of authorised medicines commonly used in children had been properly tested in this population. This rate drops 10% in the vulnerable patient population in neonatal intensive care units. Even if the situation may improve with the different paediatric legislation in place, there is still a major societal challenge to be addressed.

There are many scientific and operational challenges faced by both pharma companies and academia when running paediatric clinical trials. Given the paucity of patients available for study in many paediatric indications and the need for multiple capable sites to satisfy enrolment in trials, the clinical trial infrastructure across the EU is not sufficiently organised, and lacks adequate funds and scale to consistently and efficiently deliver both industry-sponsored and academic non-industry sponsored clinical trials leading to new drug approval, complete labelling of existing drugs, valid comparisons between existing marketed therapies, or observational studies informing the natural history of disease indications.

A broad multidisciplinary public-private consortium is required to meet the challenges and be transformative for collectively addressing children’s needs for better medicines.

Scope:The overall vision of this topic is to create a large collaborative paediatric network that facilitates the development and availability of new drugs and other therapies, and the expansion of knowledge about drugs currently in practice for the entire paediatric population.

To achieve this vision the objectives are to:

  • Create the network with a lean central coordinating organisation, arranged around “national hub coordinating centres” cooperating with multiple sites within each member state
  • Set up scientific advice and trial readiness groups
  • Test the viability of the network by conducting clinical studies
  • Develop and implement a sustainable business model for the network
  • Prepare the network to European Network for Paediatric Research at the European Medicines Agency (Enpr-EMA) membership

Expected Impact:This project will have an impact on a number of areas including

  • Better access for paediatric patients to new experimental therapies
  • Increased efficiency of executing trials (reduced timelines & cost)
  • Enhanced role of clinicians and patient/parent advocacy groups in planning and designing studies
  • Opportunity for European clinical research personnel, clinical research sites, and clinical research organisations to collaborate across national borders making Europe a more competitive place for the conduct of paediatric clinical trials
Topic conditions and documents

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    IMI2 Research and Innovation Action (IMI2-RIA) and (IMI2-IA):

    Summary of the most relevant provisions for participating in IMI2 actions
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    Standard evaluation form
    IMI2 Model Grant Agreement
    Template for essential clinical trials information

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