Staff Profile

Based at the John Walton Muscular Dystrophy Research Centre, I am the Connect4Children (c4c) Project Manager with responsibility for managing all aspects of Newcastle's contribution to the consortium. c4c is an IMI2 funded project tasked with bringing better medicines to babies, children and young people through the establishment of a pan-European Clinical Trial Network.

Newcastle University is the co-lead on two work packages of the project and I am a member of the Project Steering Committee and chair of the Communication and Dissemination Board.. In the data work package, we are working to harmonise and standardise data collected in paediatric clinical trials through introducing data standards, shared terminology and implementing the FAIR data principles within the project. In the education work package we are leading on developing scientific short courses aimed at personnel who are delivering paediatric clinical trials. 

I teach about the importance of networking in rare diseases on the following course. 

MMB8036 : Therapy Development for Rare Diseases: the neuromuscular paradigm

• Articles

  • Sen A, Palmeri A, Lee J, Hedley V, Thuet J, Lignon P, Cotonnec V, Leary R, Nally S, Straub V. Understanding paediatric data standards challenges through academia-industry partnerships: A conect4children (c4c) qualitative study. International Journal of Health Planning and Management 2022, 38(2), 277-543.
  • Sen A, Hedley V, Owen J, Cornet R, Kalra D, Engel C, Palmeri A, Lee J, Roze J, Standing J, Warris A, Pansieri C, Leary R, Turner M, Straub V. Standardizing paediatric clinical data: The development of the conect4children (c4c) cross cutting paediatric data dictionary. Journal of the Society for Clinical Data Management 2022, 2(3), 4.
  • Amadi C, Leary R, Palmeri A, Hedley V, Sen A, Siddiqui RQ, Kalra D, Straub V. 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. Applied Sciences 2022, 12(3), 1604.
  • 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, Claverol J, Nafria B, Giaquinto C. The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children. Pharmaceutical Medicine 2021, 35, 71-79.
  • Leary R, Oyewole A, Bushby K, Aarstma-Rus A. Translational Research in Europe for theAssessment and Treatment for NeuromuscularDisorders (TREAT-NMD). Neuropediatrics 2017, 48, 211-220.
  • Verhaart IEC, Robertson A, Leary R, McMacken G, Konig K, Kirschner J, Jones CC, Cook SF, Lochmuller H. A multi-source approach to determine SMA incidence and research ready population. Journal of Neurology 2017, 264(7), 1465-1473.

• Book Chapter

  • Hedley V, Leary R, Sen A, Irvin A, Heslop E, Straub V. Performing clinical drug trials in children with a rare disease. In: Elke Gasthuys; Mark Turner; Lien Dossche; Karel Allegaert, ed. Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities. Amsterdam: Elsevier, 2024. In Press.

• Conference Proceedings (inc. Abstract)

  • Degraeuwe E, Christiaens D, Sen A, Vanderschaeghe S, Persijn L, Hoste L, Nuytinck L, Palmeri A, Vande Walle J, Raes A, Leary R, Turner M. Data Standardization within Pediatrics: BPCRN’s analysis of trials identifying cross-cutting data points. In: BVK/SBP Congress 2024. 2024, Antwerp.

• Device/Product

  • Owen J, Aurich B, Bae H, Cavallaro G, Cornet R, Degraeuwe E, Engel C, Felderhoff U, Franz A, Gandini P, Hedley V, Hung A, Kalra D, Karadag B, Leary R, Luethy T, Malik S, Marshall R, Medisetti Y, Nally S, Palmeri A, Peddineni M, Presijn L, Rasegaonkar S, Schaufelberger D, Scott K, Sen A, Sokillik C, Sridharan A, Stauch A, Thuet J, Turner M, Urru S, Vanderchaeghe S, Walsh M, Woodworth S, Yoon J. Data Standards User Guide for Pediatrics (Paediatrics User Guide). 2023. Austin, TX, USA: Clinical Data Interchange Standards Consortium (CDISC).

• Online Publication

  • Palmeri A, Leary R, Sen A, Cornet R, Welter D, Rocca-Serra P. Creating a metadata profile for clinical trial protocols. Elixir FAIR Cookbook, 2023. Available at: https://faircookbook.elixir-europe.org/content/recipes/interoperability/c4c-clinical-trials.html#.