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.
Guidelines on Consent under Regulation 2016/679
This document provides a thorough analysis of the notion of consent in Regulation 2016/679, the General Data Protection Regulation (GDPR). The concept of consent as used in the Data Protection Directive (Directive 95/46/EC) and in the e-Privacy Directive to date, has evolved. The article 7 is specific for paediatric area.
The document is available here.
Guidelines on Transparency under Regulation 2016/679 (wp260rev.01)
These guidelines provide practical guidance and interpretative assistance from the Article 29 Working Party (WP29) on the new obligation of transparency concerning the processing of personal data under the General Data Protection Regulation1 (the “GDPR”). The document includes specific indications for paediatric population, specifying that where a data controller is targeting children or is, or should be, aware that their goods/services are particularly utilised by children (including where the controller is relying on the consent of the child), it should ensure that the vocabulary, tone and style of the language used is appropriate to and resonates with children so that the child addressee of the information recognises that the message/ information is being directed at them.
Further information is available here.
Summary of Clinical Trial Results for Laypersons
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.
This document provides sponsors and investigators with guidelines and templates for the production of summaries of clinical trial results for laypersons. It has been published in Eudralex Volume 10 in the Chapter V and is available at this link.
TEDDY Network participated in the public consultation proposing to include the paediatric aspect in the consultation document.
TEDDY proposal can be downloaded here.
FIP–WHO technical guidelines
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.
Ethical considerations for clinical trials on medicinal products conducted with minors
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. This document has been revised by the European Commission expert group on clinical trials in preparation for the implementation of Regulation (EU) No 536/20141 on clinical trials on medicinal products for human use. The objective of the revision is to update these recommendations to bring them in line with the new Regulation (hereinafter the Clinical Trials Regulation).
The document is available at this link.
Guidelines on Automated individual decision-making and Profiling for the purposes of Regulation 2016/679
The document provides the definitions of profiling and automated decision-making and the GDPR approach to these in general as well as the data protection impact assessments and data protection officers. Moreover, the guidelines include an ad hoc chapter on children and profiling, specifying that the GDPR creates additional obligations for data controllers when they are processing children’s personal data.
The complete document is available here.
European Pediatric Informed Consent and AF
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.
A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates
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.