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Children matter: important amendments in the draft Clinical Trials Regulation
GRiP submits proposal to ENVI committee

Global Research in Paediatrics (GRiP) believes that the current discussion on the new Clinical Trials Regulation is an opportunity to improve the health of children, and there fore the network has submitted comments on the draft Clinical Trials Regulation to the ENVI committee. Please see the following message by GRiP or download the PDF by clicking on the link at the bottom of the page.



Children matter: important amendments in the draft Clinical Trials Regulation


The draft Regulation on clinical trials does not pay sufficient attention to the needs of children and young people. The Global Research in Paediatrics Network of Excellence ( includes experts from across Europe. In principle, GRiP agrees that the new Regulation could represent a valid tool for implementing appropriated measures tailored for children, provided that fundamental rights and children standard protection, as required in Dir. 2001/20/EC and European Paediatric Recommendations are not thereby weakened. On this basis we have identified six priority areas that must be addressed when the ENVI committee finalises amendments to the draft CT Regulation (numbers refer to ENVI amendments).


1. All research must be approved by a properly constituted Ethics Committee. Recommendation: accept amendments 2, 80, 242 and 252, 305, 308, 321, 409 Justification: independent review of research is essential to safeguard research participants. Ethical and methodological evaluations cannot be separated from the assessment as whole, especially for vulnerable population.


2. All clinical trials that involve children/young people must be assessed by professionals with experience and training in working with children/young people and conducting clinical trials in children/young people (this is to include Ethics Committee review). Recommendation: accept amendments 34, 111, and 384 Justification: research involving children/young people has particular requirements that are well-known to people with appropriate experience and training but are not obvious to people who lack experience in this area.


3. Assent by children and young people needs to be recognised in law. Recommendation: accept amendments 46, 130, 177, 236, 489. Redraft amendment 49: Label 1b and 2 as “Assent”. Expand 1b to include agree to participate (not just withdraw). Justification: children/young people are capable of expressing an informed opinion about their inclusion and withdrawal from research. They expect to participate in these decisions.


4. All clinical trials involving children shall be carried out with adapted measures for vulnerable population, according to the European Paediatric Regulation and international/European existing guidelines. Recommendation: accept amendments 495, 498, 697, 702, 704, 706, 708, 709, 710, Justification: specific existing requirements for paediatric research shall be confirmed (e.g. to avoid trials when possible, to have paediatric expertise of ECs, to provide measures to reduce pain and discomfort, etc)


5. Trials that use marketed products in line with the Marketing Authorisation or normal clinical practice (including off-label use) must have less stringent requirements than other studies (including rapid approvals, no extra labelling, simplified IMP dossiers etc.) Recommendations: accept amendments 17, 18, 100, 102, (which fit with this requirement). Justification: Ensure that low-risk trials as stated in the law refer to the interventions (not to the populations). Low-risk studies include those where the medicine is part of normal clinical practice (even if used off-label).


6. Children, young people, parents and carers must be included in the design and conduct of clinical trials. Recommendation: accept amendments 33, 34, 376. Enlarge to include the involvement of children, young people and parents in the design and conduct of clinical trials. Justification : The involvement of children, young people, parents and carers must be central to the clinical trials in children and is not an optional add-on. Consultation during assessment is necessary but not sufficient.


Carlo Giaquinto (project coordinator), Mark Turner (project co-coordinator) and Annagrazia Altavilla on behalf of the GRiP network.