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NIHR Medicines for Children Research Network (MCRN)

NIHR Medicines for Children Research Network (MCRN). Dr Andrew Rose MCRN Deputy Assistant Director. Medicines for Children. Historically, limited numbers of paediatric clinical trials conducted High proportion of off-label/unlicensed medicine use Potentially leads to over/under dosing

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NIHR Medicines for Children Research Network (MCRN)

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  1. NIHR Medicines for Children Research Network (MCRN) Dr Andrew Rose MCRN Deputy Assistant Director

  2. Medicines for Children • Historically, limited numbers of paediatric clinical trials conducted • High proportion of off-label/unlicensed medicine use • Potentially leads to over/under dosing • Increased chance of adverse events • Requirement for: • More clinical trials in children • Better age-appropriate formulations • More authorised medicines and treatments

  3. EU Regulation “Better medicines for children” • 26 January 2007 • Paediatric Investigation Plan (PIP) for all new MA’s and variations • Agreement with Paediatric Committee • Waivers and deferrals • 6 month patent extension • Information included in SmPC • PUMA (data protection) • for off-patent developments • Research on older drugs (7th Framework funding) • European Paediatric Research Network (EnprEMA) More research on paediatric medicines

  4. MCRN - Vision To improve children’s health and alleviate suffering through the provision of better and safer medicines.

  5. Prof David Edwards ProfNicola Madge MCRN Coordinating Centre Consortium Prof Tony Nunn Dr William van’t Hoff Co-Director Prof Rosalind Smyth, Director Prof Paula Williamson Dr Vanessa Poustie MCRN Coordinating Centre Dr Mark Turner Prof Peter Brocklehurst

  6. MCRN – Adding Value to Study Delivery • Large network supporting randomized and other studies of medicines for children in UK NHS sites serving approx 12 million children • Supporting: • All phases (I-IV) • All therapy areas (except oncology) • Studies supported by MCRN • Publicly-sponsored • Industry-sponsored • Investigator-initiated (industry funded) Research (IIR)

  7. NIHR Clinical Research Networks

  8. Coordinating Centre • Central contact for NHS/academic investigators and industry • Dedicated teams to support public and industry studies/programmes • Detailed knowledge of/access to expertise • EU Paediatric Regulation (PIPs) • Study design/implementation • Clinical Studies Groups (CSGs) • Clinical Trials Units (CTUs) • Local Research Networks (LRNs) • Formulations • Children and family involvement info@mcrn.org.uk industry@mcrn.org.uk

  9. Local Research Networks (LRNs) LRN staff support the conduct of paediatric research in the NHS and work to Good Clinical Practice (GCP) standards • Director • Manager • Research Nurses • Pharmacists • Data entry staff • Administration

  10. Balanced Portfolio

  11. Growth of Study Portfolio

  12. Industry Studies Adopted

  13. Impact • 128 Industry studies adopted • Recruited approximately 4000 children to industry studies • Estimated expenditure of £15-20 million directly to the UK units supporting the studies • MCRN helps the UK to be selected as a location for global clinical studies • Maintains jobs in pharmaceutical, contract research organisation and supply companies, • Additional £20 million or more expenditure in UK

  14. Impact • H1N1 (swine flu) vaccine studies in children • Prevenar 13 vaccine (pneumococcal disease) to be given to all UK children (licensed across EU) • Losartan (proteinuria), PIP approved, product available • Latanoprost (glaucoma), PIP approved, product available • Other studies, data did not support use by children • In the pipeline • Mannitol (cystic fibrosis) • Tocilizumab (juvenile idiopathic arthritis) • FDA licensing April 2011, European discussions on-going • etc, etc...

  15. To discuss support that MCRN can provide, please contact: Dr Andrew Rose andrew.rose@mcrn.org.uk Tel: +44 (0)151 252 5435 www.mcrn.org.uk

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