Network building

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

2025

Authors: Attar S, Figueiras FP, Peacock C, Wohlfahrt H, Hüsken BCP, Andrews S, Lepola P, Patton M, Hankard R, Halil E, Soares FP, Tan LK, Fernandes RM, Turner MA.

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

2025

Authors: Paumard L, Hildebrand H, Engel M, Lepola P, Montero E, Tennigkeit F, Rosenmöller M

Published in: Frontiers in Medicine

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

2025

Authors: Declerck J, Lee J, Sen A, Palmeri A, Oostenbrink R, Giannuzzi V, Woodworth S, Malik S, Mahler F, Aurich B, Leary R, Kalra D, Straub V.

Published in: Journal of Medical Internet Research

“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

2025

Authors: Attar S, Peacock C, Wan M, Halil E, Bickerstaff C, Tan L, Bhatti H, Fernandes RM, Hankard R, Turner MA.

Published in: Contemporary Clinical Trials Communications

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

2025

Authors: Seigneuret N

Published in: Frontiers in Medicine

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

2025

Authors: Hari P, Khandelwal P, Boyer O, Bhimma R, Cano F, Christian M, Duzova A, Iijima K, Kang HG, Qian S, Safouh H, Samuels S, Smoyer WE, Vivarelli M,

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

2025

Authors: van Genuchten WJ, Averesch H, van Dieren QM, Bonnet D, Odermarsky M, Beghetti M, Roos-Hesselink JW, Reinhardt Z, Male C, Naumburg E, Boersma E, De Wolf D,

Paediatric-specific content in data standards for health

2025

Authors: Turner MA, Kalra D, Cornet R, Palmeri A, Sen A, Owen J, Pansieri C, Lee J, Hedley V, Nally S, Bonifazi F, Leary R, Straub V.

Published in: Archives of Disease in Childhood

Structured programs to train the next generation of clinician scientists

2025

Authors: Melk A, Grabitz C, Ernst J, Saenger T, Degraeuwe E, Beck Schimmer B, Vande Walle J, Ažukaitis K, Prakken B, Campo E, Bertero MG

Published in: Nature Medicine

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

2024

Authors: Degraeuwe E, Hovinga C, De Maré A, Fernandes RM, Heaton C, Nuytinck L, Persijn L, Raes A, Vande Walle J, Turner MA.

Published in: Frontiers in Pediatrics

The impact of the COVID-19 pandemic and the changing landscape of CF on the cASPerCF trial: a real-world experience

2024

Authors: Chesshyre ELD, Bradbury JD, Cook H, Rocchi F, Roes K, Turner MA, Brüggemann R, Warris A. 

Published in: Trials

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

2024

Authors: Attar S, Price A, Hovinga C, Stewart B, Lacaze-Masmonteil T, Bonifazi F, Turner MA, Fernandes RM.

Published in: Therapeutic Innovation & Regulatory Science

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

2024

Authors: Sen A, Hedley V, Degraeuwe E, Hirschfeld S, Cornet R, Walls R, Owen J, Robinson PN, Neilan EG, Liener T, et al. 

Published in: MDPI

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

2024

Authors: 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,

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

2024

Authors: Felisi M, Bonifazi F, Toma M, Pansieri C, Leary R, Hedley V, Cornet R, Reggiardo G, Landi A, D’Ercole A, Malik S, Nally S, Sen A, Palmeri A,

Joint recommendations on cost calculation and estimation in paediatric clinical trials

2024

Authors: Ahne G, Nagel J, Franz AR, Neubert A, Schachtrup K, Helms S, Klammt S, Schwab M. 

Published in: German Medical Science

The development of the Belgian paediatric clinical trial network

2024

Authors: Degraeuwe E, Persijn L, Nuytinck L, Allegaert K, De Taeye L, Gasthuys E, Christiaens D, Karamaria S, Raes A, Turner M, Vande Walle J. 

Published in: Acta Clinica Belgica

Psychopharmacology in children and adolescents: unmet needs and opportunities

2024

Authors: Cortese S, Purper-Ouakil D, Apter A, Arango C, Baeza I, Banaschewski T, Buitelaar J, Castro-Fornieles J, Coghill D, Cohen D, Correll CU, Grünblatt E, Hoekstra PJ, James A,

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

2024

Authors: Bouazza N, Cambonie G, Flamant C, Rideau A, Tauzin M, Patkai J, Gascoin G, Lumia M, Aikio O, Lui G, Bournaud LF, Walsh-Papageorgiou A, Tortigue M, Baruteau AE,

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

2023

Authors: Degraeuwe E, van der Geest T, Persijn L, Nuytinck L, Raes A, Turner M, Fernandes RM, Vande Walle J, de Wildt SN; IMI2 project conect4children (c4c) consortium,

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

2023

Authors: Dhaenens BAE, Mahler F, Batchelor H, Dicks P, Gaillard S, Nafria B, Kopp-Schneider A, Ribeiro MA, Schwab M, Sparber-Sauer M, Leubner J, de Wildt SN, Oostenbrink R.

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

2023

Authors: Alessandrini E, Gonakova M, Batchelor H, Gizurarson S, Iurian S, Klein S, Schaufelberger D, Turner R, Walsh J, Tuleu C.

Published in: Pharmaceutics

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

2023

Authors: Cipriani A, Seedat S, Milligan L, Salanti G, Macleod M, Hastings J, Thomas J, Michie S, Furukawa TA, Gilbert D, Soares-Weiser K, Moreno C, Leucht S, Egger M,

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

2023

Authors: 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 PJ, James A,

Digital mental health: challenges and next steps

2023

Authors: Smith KA, Blease C, Faurholt-Jepsen M, Firth J, Van Daele T, Moreno C, Carlbring P, Ebner-Priemer UW, Koutsouleris N, Riper H, Mouchabac S, Torous J, Cipriani A.

Implementation of a centralized pharmacovigilance system in academic pan-European clinical trials: Experience from EU-Response and conect4children consortia

2023

Authors: Terzić V, Levoyer L, Figarella M, Bigagli E, Mercier N, De Gastines L, Gibowski S, Trøseid M, Demotes J, Olsen IC, Hites M, Ader F, Lopez JRA,

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

2023

Authors: Cheng K, Mahler F, Lutsar I, Nafria Escalera B, Breitenstein S, Vassal G, Claverol J, Noel Palacio N, Portman R, Pope G, Bakker M, van der Geest T,

Paediatric Inflammatory Bowel Disease: A Multi-Stakeholder Perspective to Improve Development of Drugs for Children and Adolescents

2023

Authors: Croft NM, de Ridder L, Griffiths AM, Hyams JS, Ruemmele FM, Turner D, Cheng K, Lutsar I, Greco M, Gołębiewska Z, Laumond F, Cavaller-Bellaubi M, Elgreey A,

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

2023

Authors: Sen A, Hedley V, Owen J, Cornet R, Kalra D, Engel C, Palmeri A, Lee J, Roze J, Standing JF, Warris A, Pansieri C, Leary R, Turner M,

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

2023

Authors: Eleftheriou D, Moraes YC, Purvis C, Pursell M, Morillas MM, Kahn R, Mossberg M, Kucera F, Tulloh R, Standing JF, Swallow V, McCormack R, Herberg J, Levin M,

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

2022

Authors: Bouazza N, Dokoumetzidis A, Knibbe CAJ, de Wildt SN, Ambery C, De Cock PA, Gasthuys E, Foissac F, Urien S, Hamberg AK, Poggesi I, Zhao W, Vermeulen A,

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

2022

Authors: Moretti F, Ruiz F, Bonifazi F, Pizzo E, Kindblom JM; c4c HTA expert group.

Published in: British Journal of Clinical Pharmacology

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

2022

Authors: Walsh J, Schaufelberger D, Iurian S, Klein S, Batchelor H, Turner R, Gizurarson S, Boltri L, Alessandrini E, Tuleu C.

Published in: British Journal of Clinical Pharmacology

c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children – A c4c expert group white paper

2022

Authors: Aurich B, Apele-Freimane D, Banaschewski T, Chouchana L, Day S, Kaguelidou F, Kelly LE, Kindblom JM, Neubert A, Wong ICK.

Published in: British Journal of Clinical Pharmacology

Current knowledge, challenges and innovations in developmental pharmacology: A combined conect4children Expert Group and European Society for Developmental, Perinatal and Paediatric Pharmacology White Paper

2022

Authors: Smits A, Annaert P, Cavallaro G, De Cock PAJG, de Wildt SN, Kindblom JM, Lagler FB, Moreno C, Pokorna P, Schreuder MF, Standing JF, Turner MA, Vitiello B,

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

2022

Authors: Sen A, Palmeri A, Lee J, Hedley V, Thuet J, Lignon P, Cotonnec V, Leary R, Nally S, Straub V.

Published in: International Journal of Health Planning and Management

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

2022

Authors: Wan M, Alessandrini E, Brogan P, Eleftheriou D, Warris A, Brüggemann R, Turner M.

Published in: Clinical Trials

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

2022

Authors: Ramanan AV, Modi N, de Wildt SN; c4c Learning from COVID-19 Group.

Published in: Pediatric Research

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

2022

Authors: Amadi C, Leary R, Palmeri A, Hedley V, Sen A, Siddiqui RQ, Kalra D, Straub V.

Published in: Applied Sciences

How paediatric drug development and use could benefit from OMICs: A c4c expert group white paper

2022

Authors: Neumann E, Schreeck F, Herberg J, Jacqz Aigrain E, Maitland-van der Zee AH, Pérez-Martínez A, Hawcutt DB, Schaeffeler E, Rane A, de Wildt SN, Schwab M. 

Published in: British Journal of Clinical Pharmacology

Adequate Daclatasvir exposures in children 14-35 Kg with available adult formulations

2021

Authors: Cressey RT, Abbassi M, Lallemant M, Indolfi G, Al-Nahari M, Farid S, Easterbrook P, Penazzato M,  El-Sayed HM

Published in: CROI 2021

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

2021

Authors: Turner MA, Hildebrand H, Fernandes RM, de Wildt SN, Mahler F, Hankard R, Leary R, Bonifazi F, Nobels P, Cheng K, Attar S, Rossi P, Rocchi F,

Tools for Healthcare Workers to measure Health Research Capacity Development at an Individual Level

2020

Author: Bilardi D, Rapa E, Bernays S, & Lang T

Published in: European Academy of Pediatric Societies

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European research networks to facilitate drug research in children

2020

Author: Mark A. Turner, Katharine Cheng, Saskia de Wildt, Heidrun Hildebrand, Sabah Attar, Paolo Rossi, Donato Bonifazi, Adriana Ceci, Joana Claverol, Begonya Nafria, Carlo Giaquinto

Published in: British Journal of Clinical Pharmacology

 

Harmonisation preserves research resources

2020

Authors: Vasconcelos MK, Epalza C, Renk H, Tagarro A, Bielicki JA

Published in: Lancet Infect Dis. 2020;24

Respiratory pathogens detected in children with community-acquired sepsis-like syndrome in 6 European countries

2020

Authors: V. Matheeussen, K. Loens, K. Jacobs, P. Horby, H. Goossens, M. Kohns Vasconcelos, M. Sharland, M. De Jong, M. P. G. Koopmans, P. Fraaij, M. Ieven

Published in: 30th European Congress on Clinical Microbiology and Infectious Diseases (ECCMID),

Aetiology and outcome of children hospitalised for acute respiratory tract infections in Europe: findings from a multi-country combined case-control and cohort study

2020

Authors: M. Kohns Vasconcelos; on behalf of the PED-MERMAIDS Study Group

Published in: 30th European Congress on Clinical Microbiology and Infectious Diseases (ECCMID),

Non-inferiority double-blind randomised controlled trial comparing gabapentin versus tramadol for the treatment of chronic neuropathic or mixed pain in children and adolescents: the GABA-1 trial-a study protocol

2019

Authors: Kaguelidou F, Le Roux E, Mangiarini L, et al.; GAPP consortium

Published in: BMJ Open. 2019;9(2):e023296

Introduction Gabapentin is currently used ‘off-label’ in children and adolescents with chronic neuropathic pain,

Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years – evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled trial

2019

Authors: de Leeuw TG, Mangiarini L, Lundin R, et al; GAPP consortium

Published in: Trials. 2019; 20(1):368

Background Gabapentin has shown efficacy in the treatment of chronic neuropathic or mixed pain in adults.

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