3 - Specific competencies and capacity to provide export advice
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Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
c4c-S - conect4children Stichting |
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| Number of peer reviewed publications in the last 5 years | 43 | European research networks to facilitate drug research in children 10.1111/bcp.14545 The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children 10.1007/s40290-020-00373-6 Current knowledge, challenges and innovations in developmental pharmacology: a combined c4c expert group and ESDPPP White paper 10.1111/bcp.14958 Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a c4c expert group White paper.10.1111/bcp.14989 Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group10.1038/s41390-021-01587-3 C4C - Paediatric pharmacovigilance: Methodological Considerations in Research and Development of Medicines for Children – A c4c Expert Group White Paper10.1111/bcp.15119 How Can a Clinical Data Modelling Tool Be Used to Represent Data Items of Relevance to Paediatric Clinical Trials? Learning from the Conect4children (c4c) ConsortiumDOI: 10.3390/app12031604 Investing in sustainable Pediatric European Trial Networks : the value of a young investigator’s community https://biblio.ugent.be/publication/8715909 Risk-proportionate approach to paediatric clinical trials: The legal requirements, challenges, and the way forward under the European Union Clinical Trials Regulation 10.1177/17407745221093812 Data sharing in paediatric clinical research – A protocol (conect4children) DOI: 10.5281/zenodo.6514370 Paediatric inflammatory bowel disease: a multi-stakeholder perspective to improve development of drugs for children and adolescents doi.org/10.1093/ecco-jcc/jjac135 Understanding paediatric data standards challenges through academia-industry partnerships: A conect4children (c4c) qualitative study doi.org/10.1002/hpm.3592 Clinical, methodological, and patient/parent expert advice in paediatric drug development via conect4children doi.org/10.1111/cts.13459 General clinical and methodological considerations on the extrapolation of pharmacokinetics and optimization of study protocols for small molecules and monoclonal antibodies in children doi.org/10.1111/bcp.15571 Standardizing Paediatric Clinical Data: The Development of the conect4children (c4c) Cross Cutting Paediatric Data Dictionary DOI: https://doi.org/10.47912/jscdm.218 Paediatric User Guide (Data Standards User Guide for Paediatrics)Paediatric User Guide (Data Standards User Guide for Paediatrics) | Zenodo Multi-centre, randomised, open-label, blinded endpoint assessed, trial of corticosteroids plus intravenous immunoglobulin (IVIG) and aspirin, versus IVIG and aspirin for prevention of coronary artery aneurysms (CAA) in Kawasaki disease (KD): the KD CAA prevention (KD-CAAP) trial protocol DOI: 10.1186/s13063-022-07051-9 Multi-centre, randomised, open-label, blinded endpoint assessed, trial of corticosteroids plus intravenous immunoglobulin (IVIG) and aspirin, versus IVIG and aspirin for prevention of coronary artery aneurysms (CAA) in Kawasaki disease (KD): the KD CAA prevention (KD-CAAP) trial protocol 10.1111/bcp.15669 Optimizing expert and patient input in pediatric trial design: Lessons learned and recommendations from a collaboration between conect4children and European Patient-CEntric ClinicAl TRial Platforms 10.1111/cts.13547 Colour of Medicines and Children’s Acceptability? A Systematic Literature Review of Children’s Perceptions about Colours of Oral Dosage Forms 10.3390/pharmaceutics15071992 Prophylactic Intravenous Acetaminophen in Extremely Premature Infants: Minimum Effective Dose Research by Bayesian Approach 10.1007/s40272-023-00602-w Clinical trials in newborns https://www.efcni.org/wp-content/uploads/2023/04/2023_03_06_Factsheet_Clinical_trials_newborn_final.pdf The impact of the COVID-19 pandemic and the changing landscape of CF on the cASPerCF trial: a real world experience. Development of the CDISC Pediatric User Guide: A conect4children and CDISC collaboration https://doi.org/10.3389/fmed.2024.1370916 Learning from conect4children: A Collaborative Approach towards Standardization of Disease-Specific Paediatric Research Data https://doi.org/10.3390/data9040055 Creating a metadata profile for clinical trial protocols 11.5.4. Creating a metadata profile for clinical trial protocols (elixir-europe.org) Development and Performance of the c4c National Clinical Trial Networks for Optimizing Pediatric Trial Facilitation 10.3389/fped.2023.1302272 // https://doi.org/10.3389/fped.2023.1302272. The development of the Belgian paediatric clinical trial network https://doi.org/10.1080/17843286.2023.2283664 Psychopharmacology in children and adolescents: unmet needs and opportunities https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(23)00345-0/abstract Optimizing expert and patient input in pediatric trial design: Lessons learned and recommendations from a collaboration between conect4children and European Patient‐CEntric ClinicAl TRial PLatforms 10.1111/cts.13547 Digital mental health: challenges and next steps 10.1136/bmjment-2023-300670 New living evidence resource of human and non-human studies for early intervention and research prioritisation in anxiety, depression and psychosis 10.1136/bmjment-2023-300759 Collaboration in neonatal and paediatric clinical pharmacology: creating a peer-based mentoring platform in a pan-European clinical trial network.https://doi.org/10.1136/archdischild-2023-ESDPPP.12. Collaboration in neonatal and paediatric clinical pharmacology: involving medical students within (Inter)national clinical trial networks.10.1136/archdischild-2023-esdppp.7 Paediatric clinical trial needs and requirements within Belgium 10.1136/archdischild-2023-esdppp.10. The flood of study feasibilities and the value of a centralised approach 10.1136/archdischild-2023-esdppp.9. Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery 10.1007/s43441-024-00663-0 The future of child and adolescent clinical psychopharmacology: A systematic review of phase 2, 3, or 4 randomized controlled trials of pharmacologic agents without regulatory approval or for unapproved indications. 10.1016/j.neubiorev.2023.105149 |
| Number of competitive grants obtained in the last 5 years | 4 | Members of the network have all contributed as authors to each of the publications |
| Access to expert groups | Yes | The network has over 400 experts within the paediatric field, with 25 established expert groups. Additionally, we have continuous collaborations with many of the learned societies and ERN's |
| Capacity to answer external scientific questions | Yes | We have an advice service with dedicated personnel and established process to provide answer to scientific questions. Contact via single point of contact: c4c.spoc@conect4children.eu and https://conect4children.eu/ |
| Site feasibility | Yes | SOP, work instruction and templates developed, not publicly available. |
| Participant recruitment | Yes | SOP, work instruction and templates developed, not publicly available. |
| Budget calculation for studies | Yes | SOP, work instruction and templates developed, not publicly available. |