Activity of Ethics Committees in Europe on issues related to clinical trials in paediatrics: Results of a survey

Abstract

The rights and well-being of children involved in clinical research in Europe should be assured by the respect of ethical considerations and legal rules. Specific provisions are included in the Directive 2001/20/EC (CT-Dir) aimed at providing a homogeneous ethical and legal context to perform clinical trials in Europe.The TEDDY Network of Excellence carried out a "Survey on the ethical and legal frameworks existing in Europe for paediatric clinical trials" to examine the measures enforced by Member States to implement the CT-Dir and other relevant ethical norms.The results showed that many differences exist in the protection of children enrolled in clinical trials. Such differences are especially due to a non-coordinated implementation of the Directive's Article 4 and a lack of public awareness on ethical issues in this field.The recently approved 'Ethical considerations for clinical trials on medicinal products conducted with the paediatric population' should speed up the implementation of an 'ad hoc set of ethical rules' and increase the level of minors' protection. Nevertheless, in lack of 'binding rules', a coordination at European level is still needed. Public initiatives aiming at promoting in-depth debates have to be supported in order to encourage this process of coordination.

Impact of the new european paediatric regulatory framework on ethics committees: overview and perspectives

“…An inventory was carried out to identify Ethics Committees operating in Europe. The results of the first TEDDY survey (10,11) provided the approximate number of ECs and the website addresses where their contact details are available. Other sources were TEDDY and RESPECT Partners, MS Medicines Agencies and personal direct information.…”

“…• Networking may be an essential tool to be used to enhance the role of ethics committees in supporting paediatric research. Results showed that many differences exist in the protection of minors involved in clinical trials across Europe mainly because of the Directive implementation process and a lack of coordination among MS (10,11).…”

“…Between 2006 and 2007, the Task‐force in Europe for Drug Development for the Young (TEDDY), a Network of Excellence funded by the European Commission under the 6th Framework Programme, carried out a survey to examine the measures enforced by Member States (MS) to implement the CT‐Dir and other relevant European norms. Results showed that many differences exist in the protection of minors involved in clinical trials across Europe mainly because of the Directive implementation process and a lack of coordination among MS (10,11).…”

Clinical Trials in Paediatrics — Regulatory and Methodological Aspects

“…Moreover, following the approval of the Paediatric Regulation, destined to increase the number of paediatric trials, the art. 4 of Directive 2001/20/EC was considered insufficient to protect children involved in a trial [12]. The 'Ethical Recommendations on paediatric trials' issued in 2008 by the EU Commission [13], represent the more advanced regulatory framework for paediatric research in Europe.…”

“…Another example of criticism in paediatric drugs availability deals with rare diseases: both in EU and in the U.S, very few medicinal products for rare diseases affecting children have a paediatric indication 12 . As a consequence, in the U.S. (but not in EU), specific orphan programs for paediatrics have been recently proposed (Rare Pediatric Disease Priority Review Voucher Program).…”