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10 Paediatric clinical trial needs and requirements within Belgium
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  1. Eva Degraeuwe1,
  2. Laura Persijn1,
  3. Lieve Nuytinck2,
  4. Ann Raes3,
  5. Mark Turner4,
  6. Johan Vande Walle1
  1. 1Departement of Internal Medicine and Pediatrics, Ghent University
  2. 2H.I.R.U.Z., Ghent University Hospital
  3. 3Departement of Paediatric Nephrology, Ghent University Hospital
  4. 4Departement of Neonatal Pharmacology, University of Liverpool

Abstract

Introduction Due to the Paediatric Regulation in 2007, the number of paediatric clinical trials within Europe has substantially increased. Consequently, potential sites for paediatric clinical trials were overrun by trial opportunities, infrastructure pressure and their limited experience. To support sites and facilitate research, the pan-European network conect4children (c4c) was established and funded by the Innovative Medicines Initiative (IMI2). In order to attain sustainable research networks, site requirements innovation needs require further investigation.

Methods A questionnaire was conducted within the c4c Belgian Clinical trial network. An inquiry was made into the role of a national hub and other topics for support. Due to multiple responses per site, answers were grouped per site.

Results Of the 15 connected sites, we received 32 responses coming from 13 unique sites. Within the Belgian network, around 4 (30%) of sites do not have a paediatric clinical trial unit to support trials. All sites agreed or strongly agreed that a national hub is useful for the site to conduct clinical trials. The majority namely 11 (84%) of sites identified human resources as a core improvement need for sites, specifically finding dedicated clinical research nurses and finding time for principal investigators (PI) to perform study tasks aside from clinical work. A strong need for financing of infrastructure from 10 (76%) of sites is acknowledged for consultation areas, imaging, and a biobank structure.

Conclusions In order to foster sustainable development of new medicines in paediatric diseases, site need’s must to be taken into account and prioritized. The primary need is in human resources and financing of infrastructure.

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