Deliverables Documents, reports (11) First report on network preparations and progress with proof-of-viability trials First report about: a) platform statistic and feedback: users' access and satisfaction, courses quality b) numbers of site personnel who completed GCP training; c) short training stages/courses delivered; d) the 1-2 days c4c roadshow trainings delivered First report about a platform statistic and feedback users access and satisfaction courses quality b numbers of site personnel who completed GCP training c short training stagescourses delivered d the 12 days c4c roadshow trainings delivered Recommendations on how to ‘FAIR-ify’ eCRF data Recommendations on how to ‘FAIR-ify’ eCRF data (Sub-Task 5.2.3) Second report on: a) platform statistic and feedback: users’ access and satisfaction, courses quality b) numbers of site personnel who completed GCP training Report on the pilot version of the Advanced Course on Paediatric Clinical Trials and Paediatric Drug Development Report on the pilot version of the identified training curricula on paediatric drug development Master courses Second report on network preparations in the light of progress of, and experience, with proof-of-viability studies Second report on network preparations in the light of progress of and experience with proofofviability studies Report on: a) short training stages/courses delivered b) the 1-2 days c4c roadshow trainings delivered Report on the feedback received from the main private and public stakeholders Second report about: a) platform statistic and feedback: users' access and satisfaction, courses quality b) numbers of site personnel who completed GCP training; c) short training stages/courses delivered; d) the 1-2 days c4c roadshow trainings delivered Second report about a platform statistic and feedback users access and satisfaction courses quality b numbers of site personnel who completed GCP training c short training stagescourses delivered d the 12 days c4c roadshow trainings delivered Recommendations on CT data and documents archiving Guidance on CT documents archiving (Sub-Task 5.4.2) First report on: a) platform statistic and feedback: users’ access and satisfaction, courses quality b) numbers of site personnel who completed GCP training Other (4) Set up the Educational Board, Validation of E-platform customization, YPAG’S approval of material; set-up “Train-the-Trainer” program and list the trainers in each c4c institution Leadership and membership expert groups database This database will include the members of all expert groups and will make sure that there will be a clear overview of the composition of all groups. Additionally, field of expertise and membership of other, already existing networks will be specified. First press release to launch the c4c project A press release produced by the coordinator to launch and promote the project through the media and online through the website and the social networks Evaluation of E-platform based on pilot course, with reports on questionnaires and statistic about a) instructional and interaction design of the environment; b) courses quality; c) users’ access and satisfaction Evaluation of E-platform based on pilot course, with reports on questionnaires and statistic about a) instructional and interaction design of the environment; b) courses quality; c) users’ access and satisfaction. Statistics and questionnaires will be anonymous so results can be published. Publications Peer reviewed articles (15) Innovative Methodologies in paediatric drug development: a conect4children (c4c) special issue Author(s): Saskia De wildt; Ian Wong (NO NEW ASSIGNMENTS) Published in: ORCID, Issue 1, 2022, ISSN 0306-5251 Publisher: Blackwell Publishing Inc. DOI: 10.22541/au.164704116.67205499/v1 Health technology assessment of paediatric medicines: European landscape, challenges and opportunities inside the conect4children project Author(s): Francesco Moretti; Fabrice Ruiz; Fedele Bonifazi; Elena Pizzo; Jenny M. Kindblom Published in: British Journal of Clinical Pharmacology, Issue 1/8, 2021, ISSN 1365-2125 Publisher: British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society DOI: 10.1111/bcp.15190 How Can a Clinical Data Modelling Tool Be Used to Represent Data Items of Relevance to Paediatric Clinical Trials? Learning from the Conect4children (c4c) Consortium Author(s): Chima Amadi; Rebecca Leary; Avril Palmeri; Victoria Hedley; Anando Sen; Rahil Qamar Siddiqui; Dipak Kalra; Volker Straub Published in: Applied Sciences; Volume 12; Issue 3; Pages: 1604, Issue 1, 2022, ISSN 2076-3417 Publisher: MDPI DOI: 10.3390/app12031604 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 Author(s): Despina Eleftheriou; Yolanda Collaco Moraes; Cara Purvis; Molly Pursell; Marta Merida Morillas; Robin Kahn; Maria Mossberg; Filip Kucera; Robert Tulloh; Joseph F. Standing; Veronica Swallow; Rachael McCormack; Jethro Herberg; Michael Levin; Mandy Wan; Nigel Klein; Roisin Connon; Ann Sarah Walker; Paul Brogan Published in: Crossref, Issue 2, 2023, ISSN 1745-6215 Publisher: BioMed Central DOI: 10.1186/s13063-022-07051-9 Risk-proportionate approach to paediatric clinical trials: The legal requirements, challenges, and the way forward under the European Union Clinical Trials Regulation Author(s): Mandy Wan, Elisa Alessandrini, Paul Brogan, Despina Eleftheriou Adilia Warris, Roger Brüggemann and Mark Turner Published in: Clinical Trials, 2022, ISSN 1740-7753 Publisher: SAGE Journal DOI: 10.1177/17407745221093812 European research networks to facilitate drug research in children Author(s): Mark A. Turner, Katharine Cheng, Saskia Wildt, Heidrun Hildebrand, Sabah Attar, Paolo Rossi, Donato Bonifazi, Adriana Ceci, Joana Claverol, Begonya Nafria, Carlo Giaquinto Published in: British Journal of Clinical Pharmacology, 2020, ISSN 0306-5251 Publisher: Blackwell Publishing Inc. DOI: 10.1111/bcp.14545 Current knowledge, challenges and innovations in developmental pharmacology: A combined conect4children Expert Group and European Society for Developmental, Perinatal and Paediatric Pharmacology White Paper. Author(s): Anne Smits; Pieter Annaert; Giacomo Cavallaro; Pieter De Cock; Pieter De Cock; Saskia N. de Wildt; Saskia N. de Wildt; Jenny M. Kindblom; Florian B. Lagler; Carmen Moreno; Paula Pokorna; Michiel F. Schreuder; Joseph F. Standing; Joseph F. Standing; Joseph F. Standing; Mark A. Turner; Benedetto Vitiello; Wei Zhao; Annelie Martina Weingberg; Raffaella Willmann; John N. van den Anker; Karel Allegaert Published in: British Journal of Clinical Pharmacology, Issue 1, 2021, ISSN 1365-2125 Publisher: British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society DOI: 10.1111/bcp.14958 Understanding paediatric data standards challenges through academia‐industry partnerships: A conect4children (c4c) qualitative study Author(s): Anando Sen; Avril Palmeri; Joanne Lee; Victoria Hedley; Jacques Thuet; Perrine Lignon; Valerie Cotonnec; Rebecca Leary; Sinead Nally; Volker Straub Published in: Crossref, Issue 2, 2022, ISSN 0749-6753 Publisher: John Wiley & Sons Inc. DOI: 10.1002/hpm.3592 The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children Author(s): Mark A. Turner, Heidrun Hildebrand, Ricardo M. Fernandes, Saskia N. de Wildt, Fenna Mahler, Régis Hankard, Rebecca Leary, Fedele Bonifazi, Patrick Nobels, Katharine Cheng, Sabah Attar, Paolo Rossi, Francesca Rocchi, Joana Claverol, Begonya Nafria, Carlo Giaquinto Published in: Pharmaceutical Medicine, Issue 35/2, 2021, Page(s) 71-79, ISSN 1178-2595 Publisher: Adis International Ltd. DOI: 10.1007/s40290-020-00373-6 A c4c expert group white paper Author(s): Eva Neumann; Filippa Schreeck; Jethro Herberg; Evelyne Jacqz Aigrain; Anke H. Maitland‐van der Zee; Antonio Pérez‐Martínez; Daniel B. Hawcutt; Elke Schaeffeler; Anders Rane; Saskia N. Wildt; Matthias Schwab Published in: Crossref, Issue 1, 2022, ISSN 1365-2125 Publisher: British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society DOI: 10.1111/bcp.15216 Implementation of a centralized pharmacovigilance system in academic pan-European clinical trials: Experience from EU-Response and conect4children consortia Author(s): Terzic Vida, Lavoyer Lea, Figarella Melanie Published in: British Journal of Clinical Pharmacology, 2023, ISSN 0306-5251 Publisher: Blackwell Publishing Inc. DOI: 10.5167/uzh-232557 Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group. Author(s): Ramanan, Athimalaipet V.; Modi, Neena; de Wildt, Saskia N.; Aurich, Beate; Bakhtadze, Sophia; Sirvent, Francisco J. Bautista; Cabañas, Fernando; Campbell, Lisa; Casanova, Michaela; Charlton, Philippa; Crandall, Wallace; Eichler, Irmgard; Fregonese, Laura; Hawcutt, Daniel B.; Iveli, Pablo; Jaki, Thomas; Jocic-Jakubi, Bosanka; Johnson, Mats; Kaguelidou, Florentina; Karadag, Bülent; Kelly, Lauren E Published in: Pediatric Research, Issue 1, 2021, ISSN 1530-0447 Publisher: Springer Nature DOI: 10.1038/s41390-021-01587-3 A Multi-Stakeholder Perspective to Improve Development of Drugs for Children and Adolescents Author(s): Nicholas M Croft; Lissy de Ridder; Anne M Griffiths; Jeffrey S Hyams; Frank M Ruemmele; Dan Turner; Katharine Cheng; Irja Lutsar; Marco Greco; Zuzanna Gołębiewska; Floriane Laumond; Maria Cavaller-Bellaubi; Adam Elgreey; Tara A Altepeter; Chrissi Pallidis; Koen Norga; Robert Nelson; Wallace Crandall; Gilles Vassal Published in: Journal of Crohn's & colitis, 17(2), 249 - 258. Oxford University Press, Issue 1, 2023, ISSN 1873-9946 Publisher: Elsevier Science DOI: 10.1093/ecco-jcc/jjac135 Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a conect4children expert group white paper Author(s): Jennifer Walsh; Daniel Schaufelberger; Sonia Iurian; Sandra Klein; Hannah Batchelor; Roy Turner; Sveinbjörn Gizurarson; Luigi Boltri; Elisa Alessandrini; Catherine Tuleu Published in: British Journal of Clinical Pharmacology, Issue 1, 2021, ISSN 1365-2125 Publisher: British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society DOI: 10.1111/bcp.14989 c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children – A c4c expert group white paper Author(s): Beate Aurich, Dina Apele-Freimane, Tobias Banaschewski, Laurent Chouchana, Simon Day, Florentia Kaguelidou, Lauren E Kelly, Jenny M Kindblom, Antje Neubert, Ian C K Wong Published in: British Journal of Clinical Pharmacology, 2021, ISSN 1365-2125 Publisher: British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society DOI: 10.1111/bcp.15119 Conference proceedings (4) The European Paediatric Clinical Trials Network conect4children: activities of the Belgium National Network and its progression Author(s): Eva Degraeuwe; Leen De Taeye; Turner, Mark; Lieve Nuytinck; Christiaens, Daphné; Vanderschaeghe, Simon; Elke Gasthuys; Sevasti Karamaria; Van Der Straeten, Catherine; Vande Walle Published in: Ghent University Academic Bibliography, Issue 1, 2021 Publisher: Ghent University Investing in sustainable Pediatric European Trial Networks: the value of a young investigator’s community Author(s): Eva Degraeuwe (UGent) , Tessa Van der Geest, Ricardo Fernandes, Paul Malenfant, Lieve Nuytinck (UGent) , Elke Gasthuys (UGent) , Ann Raes (UGent) , Mark Turner, Johan Vande Walle (UGent) and Régis Hankard Published in: 2021 Publisher: https://biblio.ugent.be/publication?q=parent+exact+%225th+bi-annual+Conference+of+the+European+Society+of+Perinatal+and+Paediatric+Pharmacology+(ESDPPP)%2C+Abstracts%22 Investing in sustainable Pediatric European Trial Networks : the value of a young investigator’s community Author(s): Eva Degraeuwe; Geest, Tessa; Fernandes, Ricardo; Malenfant, Paul; Lieve Nuytinck; Elke Gasthuys; Ann Raes; Turner, Mark; Vande Walle; Hankard, Régis Published in: Ghent University Academic Bibliography, Issue 1, 2021 Publisher: ESDPPP The European Paediatric Clinical Trials Network conect4children : activities of the Belgium National Network and its progression Author(s): Eva Degraeuwe; Vande Walle; Lieve Nuytinck; Ann Raes Published in: Ghent University Academic Bibliography, Issue 5, 2021 Publisher: University Ghent Other (6) Data sharing in paediatric clinical research – A protocol (conect4children) Author(s): Mariagrazia Felisi; Bonifazi, Fedele; Pansieri, Claudia; Leary, Becca; Hedley, Victoria; Cornet, Ronald; Reggiardo, Giorgio; Toma, Maddalena; Landi, Annalisa; Canham, Steve; Giannuzzi, Viviana; Nally, Sinéad; Malik, Salma; Ceci, Adriana Published in: Zenodo, Issue 6, 2022 Publisher: ZENODO DOI: 10.5281/zenodo.65143 Clinical, methodology, and patient/carer expert advice in pediatric drug development by conect4children Author(s): Fenna Mahler, Katharine Cheng, Irja Lutsar, Begonya Nafria, Stefanie Breitenstein, Gilles Vassal, Joana Clavarol, Nuria Noel, Ron Portman, Gavin Pope, Martijn Bakker, Tessa van der Geest, Mark Turner, Saskia de Wildt, c4c Expert Group Leads Published in: Clinical and tranlational science, 2022 Publisher: Wiley Periodicals LLC DOI: 10.1111/cts.13459 Data sharing in paediatric clinical research – A protocol (conect4children) Author(s): Mariagrazia Felisi; Fedele Bonifazi; Maddalena Toma; Claudia Pansieri; Rebecca Leary; Victoria Hedley; Ronald Cornet; Giorgio Reggiardo; Annalisa Landi; Steve Canham; Sinéad Nally; Adriana Ceci Published in: Issue 1, 2022 Publisher: Zenodotus DOI: 10.5281/zenodo.6514370 Paediatric User Guide (Data Standards User Guide for Paediatrics) Author(s): Owen, John; Aurich, Beate; Bae, Hingung; Cavallar Giacomo; Cornet, Ronald; Degraeuwe, Eva; Engel, Corina; Felderhoff, Ursula; Franz, Axel; Gandini, Paola; Hedley, Victoria; Hung, Alexandra; Kalra, Dipak; Karadag, Bulent; Leary, Rebecca; Luethy, Thomas; Malik, Salma; Marshall, Richard; Medisetti, Yugeshwar; Nally, Sinead; Palmeri, Avril; Peddineni, Mohan; Presijn, Laura; Rasegaonkar, Sneha Nitin; S Published in: Zenodo, Issue 1, 2023 Publisher: Zenodo DOI: 10.5281/zenodo.7702316 General clinical and methodological considerations on the extrapolation of pharmacokinetics and optimization of study protocols for small molecules and monoclonal antibodies in children Author(s): Naïm BOUAZZA, Aristeidis DOKOUMETZIDIS, Catherijne A.J. KNIBBE, Saskia de WILDT, Claire AMBERY, Pieter De COCK, Frantz FOISSAC, Saïk URIEN, Anna-Karin HAMBERG, Italo POGESSI, Rob Ter HEINE, Wei ZHAO, An VERMEULEN, Joseph STANDING, Jean-Marc TRÉLUYER Published in: British Journal of Clinical Pharmacology, 2022 Publisher: British Journal of Clinical Pharmacology DOI: 10.1111/bcp.15571 Standardizing Paediatric Clinical Data: The Development of the conect4children (c4c) Cross Cutting Paediatric Data Dictionary Author(s): Anando Sen; Victoria Hedley; John Owen; Ronald Cornet; Dipak Kalra; Corinna Engel; Avril Palmeri; Joanne Lee; Jean-Christophe Roze; Joseph F Standing; Adilia Warris; Claudia Pansieri; Rebecca Leary; Mark Turner; Volker Straub Published in: Journal of the Society for Clinical Data Management, Issue 1, 2022 Publisher: Journal of the Society DOI: 10.48550/arxiv.2302.13340 Searching for OpenAIRE data... There was an error trying to search data from OpenAIRE No results available
