6 -Public Involvement
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Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
EPTRI (AISBL) - European Paediatric Translational Research Infrastructure (Association Internationale Sans But Lucrative) |
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| Involvement of patients, parents or their organisations in the protocol design | Yes | Parents/patients associations are involved in the designing of the clinical trial protocols through YPAGs and their networks. |
| Involvement of patients, parents or their organisations in creating the protocol info package | Yes | Parents/patients associations are involved in the dissemination of the activities and results through YPAGs and their networks. |
| Involvement of patients, parents or their organisations in prioritisation of needs for Clinical Trials | Yes | The engagement with young patients and young people, patients, and patient organisations to promote paediatric basic research using a patient centric approach is key to the EPTRI development. The young patients’ voice has been considered in the EPTRI development from the real beginning. To provide some examples, a toolkit for patients has been developed aimed at educating patients and families about their potential involvement in basic and translational paediatric research, with a special focus in concepts around early drug discovery and development, biomarkers, pharmacology and formulation and new technologies. The design of the interactive tool was patient-centric, as it was developed with the revision and validation of the YPAGs. Tools are also a great resource for researchers working closely with patients, families, and patients’ organisations. A general video introduces the toolkit and exemplifies with one real case the benefits of involving patients in basic research in paediatrics. Moreover, during the General Assembly meeting of EPTRI, held in Madrid at the Ministry of Health, Consumption and Social Welfare on the 27th of March, 2019, members of YPAGs were invited to a Roundtable aimed to bring the voice of the young people with real examples of their involvement in activities in the field of basic research. Several examples were introduced demonstrating that the participation of patients in research as earlier the better with the aim to include the preferences and needs of the patients. To provide some other examples, a survey to study the preferences for oral drug formulations in children was developed within EPTRI in order to include a child-friendly language and layout in the questionnaire. The survey is addressed to boys and girls up to 18 years of age (patients or healthy children) and can be completed with the help of an adult. Moreover, EPTRI has involved children in the short questionnaire, developed in collaboration with the European Paediatric Formulation Initiative (EuPFI) and aimed to understand what devices children use and how easy they are to handle, to help to find ways of making the devices more user-friendly. The survey is addressed to boys and girls between 10 to 18 years of age and their parents. Both surveys questions were reviewed by the young members of Italian, Albanian and Spanish YPAGs to guarantee that the language is comprehensible and children-friendly. In July 2024, EPTRI, as a legal entity, held a General Assembly and Scientific Meeting in conjunction with the iCAN Summit in Bari. During the summit, workshops focused on pediatric medicine formulation and drug discovery were conducted, engaging a total of 96 children from across the globe. The General Assembly included a session where feedback from these children was shared with participants, emphasizing the need to listen to and address their needs and suggestions. |