conect4children (COllaborative Network for European Clinical Trials For Children)

Informations projet

c4c

N° de convention de subvention: 777389

DOI

10.3030/777389

Projet clôturé

Date de signature de la CE 22 Juin 2018

Date de début 1 Mai 2018

Date de fin 30 Avril 2025

Financé au titre de

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coût total

€ 154 387 606,21

Contribution de l’UE

€ 67 000 000,00

Coordonné par

FONDAZIONE PENTA ETS
Italy

CORDIS fournit des liens vers les livrables publics et les publications des projets HORIZON.

Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .

Livrables

Documents, reports (12)

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 stages/courses delivered; d) the 1-2 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

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
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 stages/courses delivered; d) the 1-2 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

First 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 Assessment and Evaluation of the learners within the courses and of the performance assessment of the courses

Other (5)

"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"

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

Cross-cutting dataset delivered as a CDISC Therapeutic Area User Guide (TAUG) for paediatrics

Cross-cutting dataset delivered as a data dictionary/CDISC standard (Sub-Task 5.3.2)

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

Conference proceedings (10)

Paediatric clinical trial needs and requirements within Belgium

Auteurs: Degraeuwe E, Persijn L, Nuytinck L, Raes A, Turner M, Vande Walle J.
Publié dans: BMJ Jorunal, Numéro Vol 108 Numéro 6, 2023
Éditeur: Archives of Disease in Childhood
DOI: 10.1136/archdischild-2023-esdppp.10

Collaboration in neonatal and paediatric clinical pharmacology : creating a peer-based mentoring platform in a pan-European clinical trial network

Auteurs: Degraeuwe, Eva; van der Geest, Tessa; Persijn, Laura; Montero, Esther; Negrini, Anna; Malenfant, Paul; Stewart-Ryan, Dawn; Fernandes, Ricardo; Pokorna, Paula; Turner, Mark; Vande Walle, Johan
Publié dans: European Society of Developmental Perinal and Paediatric Pharmacology (ESDPPP) Annual Conference 2022, Abstracts, Numéro 3, 2022
Éditeur: European Society of Developmental Perinal and Paediatric Pharmacology (ESDPPP) Annual Conference 2022, Abstracts

The European Paediatric Clinical Trials Network conect4children: activities of the Belgium National Network and its progression

Auteurs: Eva Degraeuwe; Leen De Taeye; Turner, Mark; Lieve Nuytinck; Christiaens, Daphné; Vanderschaeghe, Simon; Elke Gasthuys; Sevasti Karamaria; Van Der Straeten, Catherine; Vande Walle
Publié dans: Ghent University Academic Bibliography, Numéro 1, 2021
Éditeur: Ghent University

The flood of study feasibilities and the value of a centralised approach

Auteurs: Degraeuwe E, Persijn L, Nuytinck L, Raes A, Turner M, Vande Walle J.
Publié dans: BMJ Journal, 2023
Éditeur: Archives of Disease in Childhood
DOI: 10.1136/archdischild-2023-esdppp.9

The European Health Data Space needs to be relevant for paediatric data to support future medicines development for children – a conect4children viewpoint

Auteurs: Avril Palmeri, Dipak Kalra, Ronald Cornet, Anando Sen, Joanne Lee, Victoria Hedley, Jessie Trueman, Sinead Nally, Rebecca Leary, Mark Turner
Publié dans: 2024
Éditeur: Zenodo
DOI: 10.5281/zenodo.13882704

Investing in sustainable Pediatric European Trial Networks: the value of a young investigator’s community

Auteurs: 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
Publié dans: 2021
Éditeur: 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

Auteurs: Eva Degraeuwe; Geest, Tessa; Fernandes, Ricardo; Malenfant, Paul; Lieve Nuytinck; Elke Gasthuys; Ann Raes; Turner, Mark; Vande Walle; Hankard, Régis
Publié dans: Ghent University Academic Bibliography, Numéro 1, 2021
Éditeur: ESDPPP

Collaboration in neonatal and paediatric clinical pharmacology: involving medical students within (Inter)national clinical trial networks

Auteurs: Pavlíková S, van de Walle J,Turner M, Slanař O, Pokorna P, Degraeuwe E, van der Geest T, Persijn L, Skovby P, Montero E, Negrini A, Malenfant P, Fernandes R.
Publié dans: BML Journal, 2023, Page(s) Volume 108. Numéro 6
Éditeur: Archives of Disease in Childhood
DOI: 10.1136/archdischild-2023-esdppp.7

Workshop on Engaging with the European Health Data Space: The Paediatric Perspective

Auteurs: Pameri, Avril; Leary, Rebecca; Sen, Anando; Lee, Joanne; Hedley, Victoria; Cornet, Ronald; Kalra, Dipak; Straub, Volker
Publié dans: EU Open Research Repository, Numéro 5, 2024, Page(s) v1
Éditeur: EU Open Research Repository
DOI: 10.5281/zenodo.11191557

The European Paediatric Clinical Trials Network conect4children : activities of the Belgium National Network and its progression

Auteurs: Eva Degraeuwe; Vande Walle; Lieve Nuytinck; Ann Raes
Publié dans: Ghent University Academic Bibliography, Numéro 5, 2021
Éditeur: University Ghent

Peer reviewed articles (44)

IPNA consensus definitions for clinical trial outcomes in steroid-resistant nephrotic syndrome

Auteurs: Pankaj Hari, Priyanka Khandelwal, Olivia Boyer, Rajendra Bhimma, Francesco Cano, Martin Christian, Ali Duzova, Kazumoto Iijima, Hee Gyung Kang, Shen Qian, Hesham Safouh, Susan Samuels, William E. Smoyer, Marina Vivarelli, Arvind Bagga, Franz Schaefer, null null
Publié dans: Pediatric Nephrology, Numéro 40, 2025, Page(s) 865-872, ISSN 0931-041X
Éditeur: Springer Verlag
DOI: 10.1007/s00467-024-06543-x

Colour of Medicines and Children’s Acceptability? A Systematic Literature Review of Children’s Perceptions about Colours of Oral Dosage Forms

Auteurs: Alessandrini E, Gonakova M, Batchelor H, Gizurarson S, Iurian S, Klein S, Schaufelberger D, Turner R, Walsh J, Tuleu C.
Publié dans: Journal Pharmaceutics 2023, Numéro Vol 15 Number 1992, 2023, ISSN 1999-4923
Éditeur: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics15071992

Structured programs to train the next generation of clinician scientists

Auteurs: Anette Melk, Carl Grabitz, Johanna Ernst, Thorsten Saenger, Eva Degraeuwe, Beatrice Beck Schimmer, Johan Vande Walle, Karolis Ažukaitis, Berent Prakken, Elias Campo, Michela Giulia Bertero
Publié dans: Nature Medicine, Numéro 31, 2025, Page(s) 24-27, ISSN 1078-8956
Éditeur: Nature Publishing Group
DOI: 10.1038/s41591-024-03339-2

Improving clinical paediatric research and learning from COVID-19

Auteurs: Ramanan, Athimalaipet V.; Charlton, Philippa; Crandall, Wallace; Eichler, Irmgard; Fregonese, Laura; Hawcutt, Daniel B.; Iveli, Pablo; Jaki, Thomas; Jocic-Jakubi, Bosanka; Johnson, Mats; Kaguelidou, Florentina; Modi, Neena; Karadag, Bülent; Kelly, Lauren E.; Lim, Ming; Moreno, Carmen; Neumann, Eva; Ollivier, Cécile; Oualha, Mehdi; Raffaeli, Genny; Ribeiro, Maria A.; Roilides
Publié dans: reponame:Repositório Científico de Acesso Aberto de Portugal, Numéro 1, 2021, Page(s) 1069–1077, ISSN 1530-0447
Éditeur: Pediatric Research

Clinical impact of circulating biomarkers in prediction of adverse cardiac events in patients with congenital heart disease. A systematic review

Auteurs: W.J. van Genuchten, H. Averesch, Q.M. van Dieren, D. Bonnet, M. Odermarsky, M. Beghetti, J.W. Roos-Hesselink, Z. Reinhardt, C. Male, E. Naumburg, E. Boersma, D. De Wolf, W.A. Helbing
Publié dans: International Journal of Cardiology, Numéro 421, 2025, Page(s) 132723, ISSN 0167-5273
Éditeur: Elsevier BV
DOI: 10.1016/j.ijcard.2024.132723

Developing and streamlining clinical trial services to support pediatric drug development across 21 countries in Europe: insights from the conect4children (c4c) network

Auteurs: Sabah Attar, Francisca P. Figueiras, Carla Peacock, Hazel Wohlfahrt, Birgitta C. P. Hüsken, Susan Andrews, Pirkko Lepola, Margaret Patton, Regis Hankard, Eren Halil, Fernando Pontes Soares, Lionel K. Tan, Ricardo M. Fernandes, Mark A. Turner
Publié dans: Frontiers in Medicine, Numéro 12, 2025, ISSN 2296-858X
Éditeur: Frontiers Media SA
DOI: 10.3389/fmed.2025.1531276

Innovative Methodologies in paediatric drug development: a conect4children (c4c) special issue

Auteurs: Saskia De wildt; Ian Wong (NO NEW ASSIGNMENTS)
Publié dans: ORCID, Numéro 1, 2022, ISSN 0306-5251
Éditeur: Blackwell Publishing Inc.
DOI: 10.22541/au.164704116.67205499/v1

Gemeinsame Empfehlungen zur Kostenermittlung und -abschätzung in pädiatrischen klinischen Studien

Auteurs: Ahne, Gabriele; Nagel, Julia; Franz, Axel R.; Neubert, Antje; Schachtrup, Kristina; Helms, Simone; Klammt, Sebastian; Schwab, Matthias
Publié dans: GMS German Medical Science, Numéro 3, 2024, ISSN 1612-3174
Éditeur: Association of the Scientific Medical Societies

Health technology assessment of paediatric medicines: European landscape, challenges and opportunities inside the conect4children project

Auteurs: Francesco Moretti; Fabrice Ruiz; Fedele Bonifazi; Elena Pizzo; Jenny M. Kindblom
Publié dans: British Journal of Clinical Pharmacology, Numéro 1/8, 2021, ISSN 1365-2125
Éditeur: British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society
DOI: 10.1111/bcp.15190

Psychopharmacology in children and adolescents: unmet needs and opportunities

Auteurs: Cortese S, Purper-Ouakil D, Apter A, Arango C, Baeza I
Publié dans: The Lancet Psychiatry, Numéro VOLUME 11, ISSUE 2, 2023, Page(s) P143-154, ISSN 2215-0374
Éditeur: Elsevier
DOI: 10.1016/s2215-0366(23)00345-0

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

Auteurs: Chima Amadi; Rebecca Leary; Avril Palmeri; Victoria Hedley; Anando Sen; Rahil Qamar Siddiqui; Dipak Kalra; Volker Straub
Publié dans: Applied Sciences; Volume 12; Numéro 3; Pages: 1604, Numéro 1, 2022, ISSN 2076-3417
Éditeur: MDPI
DOI: 10.3390/app12031604

11 Clinical, methodological and patient/parent expert advice in paediatric drug development via conect4children

Auteurs: Fenna Mahler, Katharine Cheng, Irja Lutsar, Begonya Nafria Escalera, Mark Turner, Saskia de Wildt
Publié dans: Archives of Disease in Childhood, Numéro 108, 2023, Page(s) A4.1-A4, ISSN 0003-9888
Éditeur: BMJ Publishing Group
DOI: 10.1136/archdischild-2023-esdppp.11

Prophylactic Intravenous Acetaminophen in Extremely Premature Infants: Minimum Effective Dose Research by Bayesian Approach

Auteurs: Bouazza N, Cambonie G, Flament C, Rideau A, Tauzin M, Patkai J, Gascoin G, Lumia M, Ailio O, Lui G, Bournaud L F, Walsh-Papageorgiou A, Tortigue M, Baruteau A, Kalio J, Hallman M, Diallo A, Levoyer L, Treluyer JM, Roze JC
Publié dans: Pediatric Drugs, Numéro Volume 26, pages 83–93, 2023, ISSN 1179-2019
Éditeur: Springer Link
DOI: 10.1007/s40272-023-00602-w

Learning from conect4children: A Collaborative Approach towards Standardisation of Disease-Specific Paediatric Research Data

Auteurs: Sen, A.; Hedley, V.; Degraeuwe, E.; Hirschfeld, S.; Cornet, R.; Walls, R.; Owen, J.; Robinson, P.N.; Neilan, E.G.; Liener, T.; et al.
Publié dans: Data, 2024, Page(s) Volume 9(Numéro 4), Pag 55, ISSN 2306-5729
Éditeur: Zenodo
DOI: 10.3390/data9040055

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

Auteurs: 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
Publié dans: Crossref, Numéro 2, 2023, ISSN 1745-6215
Éditeur: BioMed Central
DOI: 10.1186/s13063-022-07051-9

PI-07: THE INTERNATIONAL HEMOGLOBINOPATHY RESEARCH NETWORK (INHERENT): AN INTERNATIONAL INITIATVE TO STUDY THE ROLE OF GENETIC MODIFIERS IN HEMOGLOBINOPATHIES

Auteurs: KOUNTOURIS P., STEPHANOU C., ARCHER N., BONIFAZI F., GIANNUZZI V., KUO K., MAGGIO A., MAKANI J., MAÑÚ PEREIRA M., MICHAILIDOU K., NKYA S., NNODU O., TROMPETER S., TSHILOLO L., WONKAM A., ZILFALIL B., INUSA B., KLEANTHOUS M.
Publié dans: HemaSphere, Numéro 6, 2023, Page(s) 12-13, ISSN 2572-9241
Éditeur: Wiley
DOI: 10.1097/01.hs9.0000872888.56941.7d

“Common sense is hard work” but benefits from persistent collaboration: Lessons learnt from the development of The Collaborative Network for European Clinical Trials for Children (c4c) to support the conduct of paediatric clinical trials of medicines

Auteurs: Sabah Attar, Carla Peacock, Mandy Wan, Erin Halil, Chloe Bickerstaff, Lionel Tan, Hafsah Bhatti, Ricardo M. Fernandes, Regis Hankard, Mark A. Turner
Publié dans: Contemporary Clinical Trials Communications, Numéro 44, 2025, Page(s) 101442, ISSN 2451-8654
Éditeur: Elsevier BV
DOI: 10.1016/j.conctc.2025.101442

Mapping of Data-Sharing Repositories for Paediatric Clinical Research—A Rapid Review

Auteurs: Mariagrazia Felisi, Fedele Bonifazi, Maddalena Toma, Claudia Pansieri, Rebecca Leary, Victoria Hedley, Ronald Cornet, Giorgio Reggiardo, Annalisa Landi, Annunziata D’Ercole, Salma Malik, Sinéad Nally, Anando Sen, Avril Palmeri, Donato Bonifazi, Adriana Ceci
Publié dans: Data, Numéro 9, 2024, Page(s) 59, ISSN 2306-5729
Éditeur: MDPI AG
DOI: 10.3390/data9040059

Collaboration for rare diabetes: understanding new treatment options for Wolfram syndrome

Auteurs: Felix Reschke, Julia Rohayem, Pietro Maffei, Francesca Dassie, Anke Schwandt, Carine de Beaufort, Sonia Toni, Agnieszka Szypowska, Roque Cardona-Hernandez, Nicolin Datz, Katharina Klee, Thomas Danne
Publié dans: Endocrine, Numéro 71, 2021, Page(s) 626-633, ISSN 1355-008X
Éditeur: Humana Press, Inc.
DOI: 10.1007/s12020-021-02622-3

Development of the CDISC Pediatrics User Guide: a CDISC and conect4children collaboration

Auteurs: Owen J, Sen A, Aurich B, Engel C, Cavallaro G, Degraeuwe E, Kalra D, Cornet R, Walsh M, Berkery T, Palmeri A, Mahler F, Malik S, Persijn L, Amadi C, Thuet J, Woodworth S, Nally S, Leary R, Marshall R, Straub V.
Publié dans: Frontiers in Medicine, Numéro Sec. Regulatory Science Volume 11 - 2024, 2024, ISSN 2296-858x
Éditeur: Frontiers in Medicine
DOI: 10.3389/fmed.2024.1370916

Risk-proportionate approach to paediatric clinical trials: The legal requirements, challenges, and the way forward under the European Union Clinical Trials Regulation

Auteurs: Mandy Wan, Elisa Alessandrini, Paul Brogan, Despina Eleftheriou Adilia Warris, Roger Brüggemann and Mark Turner
Publié dans: Clinical Trials, 2022, ISSN 1740-7753
Éditeur: SAGE Journal
DOI: 10.1177/17407745221093812

The Potential to Leverage Real-World Data for Pediatric Clinical Trials: A Proof-of-Concept Study

Auteurs: Jens Declerck, Joanne Lee, Anando Sen, Avril Palmeri, Rianne Oostenbrink, Viviana Giannuzzi, Simon Woodworth, Salma Malik, Fenna Mahler, Beate Aurich, Rebecca Leary, Dipak Kalra, Volker Straub
Publié dans: Journal of Medical Internet Research, Numéro 27, 2025, Page(s) e72573, ISSN 1438-8871
Éditeur: Journal of medical Internet Research
DOI: 10.2196/72573

European research networks to facilitate drug research in children

Auteurs: Mark A. Turner, Katharine Cheng, Saskia Wildt, Heidrun Hildebrand, Sabah Attar, Paolo Rossi, Donato Bonifazi, Adriana Ceci, Joana Claverol, Begonya Nafria, Carlo Giaquinto
Publié dans: British Journal of Clinical Pharmacology, 2020, ISSN 0306-5251
Éditeur: 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.

Auteurs: 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
Publié dans: British Journal of Clinical Pharmacology, Numéro 1, 2021, ISSN 1365-2125
Éditeur: British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society
DOI: 10.1111/bcp.14958

Sufentanil Disposition and Pharmacokinetic Model-Based Dosage Regimen for Sufentanil in Ventilated Full-Term Neonates

Auteurs: Pavla Pokorná; Martin Šíma; Birgit Koch; Dick Tibboel; Ondřej Slanař
Publié dans: urn:issn:0031-7012, Numéro 1, 2021, ISSN 0031-7012
Éditeur: S. Karger AG
DOI: 10.1159/000515787

Understanding paediatric data standards challenges through academia‐industry partnerships: A conect4children (c4c) qualitative study

Auteurs: Anando Sen; Avril Palmeri; Joanne Lee; Victoria Hedley; Jacques Thuet; Perrine Lignon; Valerie Cotonnec; Rebecca Leary; Sinead Nally; Volker Straub
Publié dans: Crossref, Numéro 2, 2022, ISSN 0749-6753
Éditeur: John Wiley & Sons Inc.
DOI: 10.1002/hpm.3592

Joint recommendations on cost calculation and estimation in paediatric clinical trials

Auteurs: Ahne G, Nagel J, Franz AR, Neubert A, Schachtrup K, Helms S, Klammt S, Schwab M.
Publié dans: GMS German Medical Science- an Interdisciplinary Journal, 2024, ISSN 1612-3174
Éditeur: Association of the Scientific Medical Societies
DOI: 10.3205/000330

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

Auteurs: Cortese, Samuele; McGinn, Katherine; Højlund, Mikkel; Apter, Alan; Arango, Celso; Baeza, Immaculada; Banaschewski, Tobias; Buitelaar, Jan; Castro-Fornieles, Josefina; Coghill, David; Cohen, David; Grünblatt, Edna; Hoekstra, Pieter J; James, Anthony; Jeppesen, Pia; Nagy, Péter; Pagsberg, Anne Katrine; Parellada, Mara; Persico, Antonio M; Purper-Ouakil, Diane; Roessner, Veit; Santosh, Paramala; S
Publié dans: Cortese , S , McGinn , K , Højlund , M , Apter , A , Arango , C , Baeza , I , Banaschewski , T , Buitelaar , J , Castro-Fornieles , J , Coghill , D , Cohen , D , Grünblatt , E , Hoekstra , P J , James , A , Jeppesen , P , Nagy , P , Pagsberg , A K , Parellada , M , Persico , A M , Purper-Ouakil , D , Roessner , V , Santosh , P , Simonoff , E , Stevanovic , D , Stringaris , A , Vitiello , B , Wal, Numéro 1, 2023, Page(s) Volume 149, ISSN 1873-7528
Éditeur: ELSEVIER
DOI: 10.1016/j.neubiorev.2023.105149

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

Auteurs: Dhaenens, B.A.E.; Mahler, F.M.; Batchelor, H.; Dicks, P.; Gaillard, S.; Nafria, B.; Kopp-Schneider, A.; Ribeiro, M.A.; Schwab, M.; Sparber-Sauer, M.; Leubner, J.; de Wildt, S.N.; de Wildt, S.N.; Oostenbrink, R.
Publié dans: Clinical and Translational Science, Vol 16, Iss 8, Pp 1458-1468 (2023), Numéro 1, 2023, Page(s) Volume16, Numéro8 August 2023 Pages 1458-1468, ISSN 1752-8054
Éditeur: Wiley-Blackwell
DOI: 10.1111/cts.13547

Development and performance of the c4c national clinical trial networks for optimizing pediatric trial facilitation

Auteurs: Degraeuwe E, van der Geest T, Persijn L, Nuytinck L, Raes A, Turner M, Fernandes RM, Vande Walle J, de Wildt SN
Publié dans: Frontiers in Pediatrics, Numéro Front. Pediatr., 21 December 2023 Sec. Children and Health, 2023, Page(s) Volume 11 - 2023, ISSN 2296-2360
Éditeur: Frontiers Media SA
DOI: 10.3389/fped.2023.1302272

Partnership of I-ACT for children (US) and European pediatric clinical trial networks to facilitate pediatric clinical trials

Auteurs: Eva Degraeuwe, Collin Hovinga, Annelies De Maré, Ricardo M. Fernandes, Callie Heaton, Lieve Nuytinck, Laura Persijn, Ann Raes, Johan Vande Walle, Mark A. Turner
Publié dans: Frontiers in Pediatrics, Numéro 12, 2024, ISSN 2296-2360
Éditeur: Frontiers Media SA
DOI: 10.3389/fped.2024.1388170

Advancing European paediatric research - the contribution of the Innovative Health Initiative

Auteurs: Nathalie Seigneuret
Publié dans: Frontiers in Medicine, Numéro 12, 2025, ISSN 2296-858X
Éditeur: Frontiers Media SA
DOI: 10.3389/fmed.2025.1553448

The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children

Auteurs: 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
Publié dans: Pharmaceutical Medicine, Numéro 35/2, 2021, Page(s) 71-79, ISSN 1178-2595
Éditeur: Adis International Ltd.
DOI: 10.1007/s40290-020-00373-6

A c4c expert group white paper

Auteurs: 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
Publié dans: Crossref, Numéro 1, 2022, ISSN 1365-2125
Éditeur: 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

Auteurs: Terzic Vida, Lavoyer Lea, Figarella Melanie
Publié dans: British Journal of Clinical Pharmacology, 2023, ISSN 0306-5251
Éditeur: Blackwell Publishing Inc.
DOI: 10.5167/uzh-232557

Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group.

Auteurs: 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
Publié dans: Pediatric Research, Numéro 1, 2021, ISSN 1530-0447
Éditeur: Springer Nature
DOI: 10.1038/s41390-021-01587-3

The development of the Belgian paediatric clinical trial network

Auteurs: Degraeuwe E, Turner M, Vande Walle J. Persijn L, Nuytinck L, Allegaert K, De Taeye L, Gasthuys E, Christiaens D,Karamaria S, Raes A.
Publié dans: International Journal of Clinical and Laboratory Medicine, Numéro Volume 79, 2024 - Numéro 1, 2023, Page(s) Pages 34-45, ISSN 2295-3337
Éditeur: Acta Clinica Belgica
DOI: 10.1080/17843286.2023.2283664

Paediatric-specific content in data standards for health

Auteurs: Mark A Turner, Dipak Kalra, Ronald Cornet, Avril Palmeri, Anando Sen, John Owen, Claudia Pansieri, Joanne Lee, Victoria Hedley, Sinead Nally, Fedele Bonifazi, Rebecca Leary, Volker Straub
Publié dans: Archives of Disease in Childhood, Numéro 110, 2025, Page(s) 177-179, ISSN 0003-9888
Éditeur: BMJ Publishing Group
DOI: 10.1136/archdischild-2024-327931

New living evidence resource of human and non-human studies for early intervention and research prioritisation in anxiety, depression and psychosis [perspective].

Auteurs: Cipriani, Andrea; Seedat, Soraya; Milligan, Lea; Salanti, Georgia; Macleod, Malcolm; Hastings, Janna; Thomas, James; Michie, Susan; Furukawa, Toshi A; Gilbert, David; Soares-Weiser, Karla; Moreno, Carmen; Leucht, Stefan; Egger, Matthias; Mansoori, Parisa; Barker, James M; Siafis, Spyridon; Ostinelli, Edoardo Giuseppe; McCutcheon, Robert; Wright, Simonne; Simpson, Matilda; Elugbadebo, Olufisayo; Ch
Publié dans: Cipriani, Andrea; Seedat, Soraya; Milligan, Lea; Salanti, Georgia; Macleod, Malcolm; Hastings, Janna; Thomas, James; Michie, Susan; Furukawa, Toshi A; Gilbert, David; Soares-Weiser, Karla; Moreno, Carmen; Leucht, Stefan; Egger, Matthias; Mansoori, Parisa; Barker, James M; Siafis, Spyridon; Ostinelli, Edoardo Giuseppe; McCutcheon, Robert; Wright, Simonne; ... (2023). New living evidence resource of, Numéro 11, 2023, Page(s) vol26, ISSN 2755-9734
Éditeur: BMJ
DOI: 10.48350/183274

A Multi-Stakeholder Perspective to Improve Development of Drugs for Children and Adolescents

Auteurs: 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
Publié dans: Journal of Crohn's & colitis, 17(2), 249 - 258. Oxford University Press, Numéro 1, 2023, ISSN 1873-9946
Éditeur: Elsevier Science
DOI: 10.1093/ecco-jcc/jjac135

Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery

Auteurs: Sabah Attar, Angie Price, Collin Hovinga, Breanne Stewart, Thierry Lacaze-Masmonteil, Fedele Bonifazi, Mark A. Turner, Ricardo M. Fernandes
Publié dans: Therapeutic Innovation & Regulatory Science, Numéro 58, 2024, Page(s) 953-964, ISSN 2168-4790
Éditeur: SAGE Publications Inc.
DOI: 10.1007/s43441-024-00663-0

Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a conect4children expert group white paper

Auteurs: Jennifer Walsh; Daniel Schaufelberger; Sonia Iurian; Sandra Klein; Hannah Batchelor; Roy Turner; Sveinbjörn Gizurarson; Luigi Boltri; Elisa Alessandrini; Catherine Tuleu
Publié dans: British Journal of Clinical Pharmacology, Numéro 1, 2021, ISSN 1365-2125
Éditeur: 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

Auteurs: 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
Publié dans: British Journal of Clinical Pharmacology, 2021, ISSN 1365-2125
Éditeur: British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society
DOI: 10.1111/bcp.15119

Current knowledge, challenges and innovations in developmental pharmacology

Auteurs: Smits, Anne; Annaert, Pieter; Cavallaro, Giacomo; De Cock, Pieter A.J.G.; de Wildt, Saskia N.; Kindblom, Jenny M.; Lagler, Florian B.; Moreno, Carmen; Pokorna, Paula; Schreuder, Michiel F.; Standing, Joseph F.; Turner, Mark A.; Vitiello, Benedetto; Zhao, Wei; Weingberg, Annelie Martina; Willmann, Raffaella; van den Anker, John; Allegaert, Karel
Publié dans: British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society., Numéro 1, 2021, ISSN 0306-5251
Éditeur: Blackwell Publishing Inc.
DOI: 10.1111/bcp.14958

Other (12)

GLOPAD Paediatric Use Case: Important Considerations in Assessing the Population Representativeness of Paediatric Clinical Trials

Auteurs: Anando Sen, Kasey Baker, Fedele Bonifazi, Beate Aurich, Neena Modi, Teresa Berkery, Giorgio Reggiardo, Levi Hoste, Melissa Walsh, Sinead Nally, Eleanor Kennedy, Avril Palmeri, Rebecca Leary, Claudia Pansiery, Julia Anna Bielicki, Annuziata D'Ercole
Publié dans: Zenodo, 2025
Éditeur: Zenodo
DOI: 10.5281/zenodo.15262751

Data sharing in paediatric clinical research – A protocol (conect4children)

Auteurs: 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
Publié dans: Zenodo, Numéro 6, 2022
Éditeur: ZENODO
DOI: 10.5281/zenodo.65143

Clinical, methodology, and patient/carer expert advice in pediatric drug development by conect4children

Auteurs: 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
Publié dans: Clinical and tranlational science, 2022
Éditeur: Wiley Periodicals LLC
DOI: 10.1111/cts.13459

Paediatric pharmacological development through a European clinical trial network conect4children (c4c) : activities of the Belgian National Network and its progression

Auteurs: Eva Degraeuwe; Turner, Mark; Lieve Nuytinck; Christiaens, Daphné; Vanderschaeghe, Simon; Elke Gasthuys; Sevasti Karamaria; Van Der Straeten, Catherine; Vande Walle
Publié dans: Ghent University Academic Bibliography, Numéro 2, 2021
Éditeur: European Society of Perinatal and Paediatric Pharmacology (ESDPPP)

The route to financial sustainability of a large Public Private Partnership—the example of the clinical trial network conect4children (c4c)

Auteurs: Laetitia Paumard Heidrun Hildebrand, Marianne Engel, Pirkko Lepola, Esther Montero, Frank Tennigkeit and Magda Rosenmöller
Publié dans: Frontiers in Medicine, 2025
Éditeur: Frontier
DOI: 10.3389/fmed.2025.1599997

Data sharing in paediatric clinical research – A protocol (conect4children)

Auteurs: Mariagrazia Felisi; Fedele Bonifazi; Maddalena Toma; Claudia Pansieri; Rebecca Leary; Victoria Hedley; Ronald Cornet; Giorgio Reggiardo; Annalisa Landi; Steve Canham; Sinéad Nally; Adriana Ceci
Publié dans: Numéro 1, 2022
Éditeur: Zenodotus
DOI: 10.5281/zenodo.6514370

Paediatric User Guide (Data Standards User Guide for Paediatrics)

Auteurs: 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
Publié dans: Zenodo, Numéro 1, 2023
Éditeur: Zenodo
DOI: 10.5281/zenodo.7702316

Creating a metadata profile for clinical trial protocols

Auteurs: Palmeri A, Leary R, Sen A, Cornet R, Welter D, Rocca-Serra P.
Publié dans: The FAIR cookbook, 2023
Éditeur: NA

General clinical and methodological considerations on the extrapolation of pharmacokinetics and optimization of study protocols for small molecules and monoclonal antibodies in children

Auteurs: 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
Publié dans: British Journal of Clinical Pharmacology, 2022
Éditeur: British Journal of Clinical Pharmacology
DOI: 10.1111/bcp.15571

Creating a metadata profile for clinical trial protocols

Auteurs: Palmeri, Avril; Leary, Rebecca; Sen, Anando; Cornet, Ronald; Welter, Danielle; Rocca-Serra, Philippe
Publié dans: Numéro 4, 2023, Page(s) v1
Éditeur: zenodo
DOI: 10.5281/zenodo.10076332

Standardizing Paediatric Clinical Data: The Development of the conect4children (c4c) Cross Cutting Paediatric Data Dictionary

Auteurs: 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
Publié dans: Journal of the Society for Clinical Data Management, Numéro 1, 2022
Éditeur: Journal of the Society
DOI: 10.48550/arxiv.2302.13340

Report and recommendations to leverage the potential of data sharing between paediatric clinical trials and EHRs

Auteurs: Kalra, Dipak; Lee, Joanne; Declerck, Jens; Sen, Anando; Hedley, Victoria; Palmeri, Avril; Leary, Rebecca; Straub, Volker
Publié dans: Zenodo, Numéro 1, 2024
Éditeur: Zenodo
DOI: 10.5281/zenodo.14035475

Book chapters (2)

Principles of performing pediatric clinical drug trials

Auteurs: Eva Degraeuwe, Johan Vande Walle, Kim Jennings, Pirkko Lepola
Publié dans: Essentials of Translational Pediatric Drug Development, 2024, Page(s) 349-384
Éditeur: Elsevier
DOI: 10.1016/b978-0-323-88459-4.00015-8

Worldwide network initiatives in improving pediatric drug research

Auteurs: Sabah Attar, Eva Degraeuwe, Johan Vande Walle, Mark A. Turner
Publié dans: Essentials of Translational Pediatric Drug Development, 2024, Page(s) 593-627
Éditeur: Elsevier
DOI: 10.1016/b978-0-323-88459-4.00023-7