TEDDY provides in this section links to relevant publications or guidelines which were believed to be of interest for the Network. We also provide clarifications and comments on their contents if it is deemed useful to stimulate the scientific debate. TEDDY disclaims all liability arising from the information or materials contained on any linked sites.
Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use.
TEDDY Network participated in the public consultation proposing to include the paediatric aspect in the consultation document.
TEDDY proposal can be download here.
Points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products, published in May 2016, available at: http://fip.org/www/uploads/database_file.php?id=375&table_id
TEDDY comments:
According to GRiP (Global Research in Paediatrics), TEDDY believes that all children should have access to age-appropriate medicines which have been researched and developed and approved by a national or international competent authority. In this perspective industrially-prepared age/weight appropriate forms and formulations are optimal for children. GRiP also recognises that this ideal will take time to achieve in many countries and that in some situations it may be necessary to manipulate dosage forms intended for adults or, even to prepare medicines extemporaneously from active drugs and other ingredients. There is potential for inaccurate dosing and even hazard if manipulation is not undertaken effectively. GRiP endorses the FIP – WHO technical guidelines which are very important for most resource limited settings: Points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products and recommends that the guidance is followed until such time as appropriate authorised medicines become available to the patients.
The Article “European Pediatric Informed Consent and AF: Current Status of Country Requirements” has been published by the Paediatric Working Group of EUCROF, the European CRO Federation.
The Paediatric Working Group is aimed to improve clinical research in children, to improve the relationships between CROs, pharmaceutical industry ena competent authorities and to make society aware about the importance of paediatric research in order to get better medicines for children.
The article is available at this link.
Neonatal trials remain difficult to conduct for several reasons: in particular, the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. The objective of this work was to identify the major criteria considered necessary for selecting neonatal intensive care units that are able to perform drug evaluations competently.
This Delphi process was conducted with an international multidisciplinary panel of 25 experts from 13 countries, in order to validate criteria required to perform drug evaluation in neonates.
This work is part of the GRIP project (Global Research in Paediatrics) which aims to implement an infrastructure matrix to stimulate and facilitate the development and safe use of medicine in children. GRiP objectives are to create consensus on international standards, methodologies and tools for paediatric research. The link to the publication is available here.