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NIHR Clinical Research Networks – what they mean for paediatrics

NIHR Clinical Research Networks – what they mean for paediatrics. Rosalind L Smyth, Director MCRN. Plan of talk. UKCRN and the history. MCRN – brief update. Comprehensive Clinical Research Network. Implications for organisation and support of paediatric research.

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NIHR Clinical Research Networks – what they mean for paediatrics

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  1. NIHR Clinical Research Networks – what they mean for paediatrics Rosalind L Smyth, Director MCRN

  2. Plan of talk • UKCRN and the history. • MCRN – brief update. • Comprehensive Clinical Research Network. • Implications for organisation and support of paediatric research.

  3. UK Clinical Research Network Comprehensive Research Networks

  4. National Cancer Research Network • Established 2001 • Coordinating Centre in Leeds • 40 Local Research Networks across the UK • Total population 60.2 million (100% coverage) • 474 studies in the portfolio

  5. National Cancer Research Network Comparison of recruitment into Myeloma VII (pre-NCRN) and Myeloma IX (post-NCRN)

  6. National Cancer Research Network Accrual to NCRN Portfolio studies Across the UK

  7. Introduction of Clinical Research Networks FIRST PHASE NCRN 2000~£20M MHRN2003~£ 4M SECOND PHASE (TCRN’s) MCRN, DRN, SRN, DeENDroN 2005~£16M THIRD PHASE Primary Care Research Network 2007~£ 2MComprehensive Research Network 2007~£90M+

  8. Rosalind Smyth Director Information Systems Chris Braithwaite Clinical Trials Unit Four core staff Paula Williamson Portfolio Manager To be appointed Industry Liaison Officer Andrew Rose Tony Nunn Training & Education Sarah McCauley David Edwards Assistant Director Vanessa Poustie Consumer Involvement Jenny Preston Nicola Madge/NCB Clinical Studies Groups Jennifer Blakeburn Administrative support Moira Saphier Kathy McKenna Neonatal Network Coordinator Sara Lewis NPEU MCRN Co-ordinating Centre – Organogram and Workstreams

  9. MCRN Local Research Networks Cheshire, Merseyside & North Wales Greater Manchester, Lancashire & S.Cumbria West Midlands Trent South West SENCE

  10. MCRN Local Research NetworksFunding: each LRN, £500K per annum LRN Director UKCRN MCRN Local Clinical Leads LRN Manager Infrastructure support funding also includes service support costs in the NHS Research staff 1 Administrator 6-7 Research Officers Pharmacist Other support staff Formulations Scientist (in 3 LRNs)

  11. MCRN Clinical Studies Groups Allergy,Nephrology, Infection & ImmunityDr Mike Sharland Anaesthesia, Pain, Intensive Care, Cardiology (APICC) Dr Robert Tasker Diabetes, Endocrinology & Metabolic MedicineProf David Dunger Gastroenterology, Hepatology & NutritionDr Stephen Murphy General Paediatrics (including Dermatology)Dr Colin Powell Methodology Prof Peter Brocklehurst NeonatalProf David Field Neurosciences Dr William Whitehouse Pharmacy & PharmacologyProf Ian Wong Respiratory & Cystic FibrosisProf Jonathan Grigg Rheumatology (MCRN/arc) Dr Michael Beresford Children’s Cancer and Leukaemia Group (CCLG)Dr Bruce Morland

  12. What is the UKCRN Portfolio? • A national register of all eligible studies • DH have defined ‘eligible’ for England – NIHR portfolio • Emphasis on national competitive funding and external peer review • Portfolios in Northern Ireland, Scotland and Wales • Aim is UK-wide working within portfolios • multi-centre and single centre • commercial and non-commercial Details of current portfolio available on UKCRN website (www.ukcrn.org.uk) (in development)

  13. MCRN Portfolio Studies • 51 studies adopted into Network • 40 Non-commercial • 11 Commercial - 9 different companies • Studies at different stages • Many different therapeutic areas • UKCRN Portfolio Database • More studies in pipeline

  14. MCRN Portfolio studies

  15. MCRN Portfolio studies

  16. Comprehensive Clinical Research Network (CCRN) • to provide the NHS infrastructure to support clinical research-25 CLRNs • streamline the research management function--reduce bureaucracy where possible • Inclusive of all healthcare • From April 2009 will be the main route for NHS service support for clinical research

  17. What is a Comprehensive Local Research Network? • Primary vehicle for NHS infrastructure (service support) • Primary, secondary and tertiary care and MH • Clinical Director and Network Manager and core team • Network Executive and Network Board • Host organisation • Research management for portfolio • A typical CLRN: - NHS staff – management, sessions forclinicians, nurses, data managers, secretarial. - infrastructure in primary care. - diagnostics and service costs. - running costs.

  18. CLRN- A balance between national standards and consistency and local ownership and control! Geography-functional clinical research entities Host Organisations Clinical Directors Network Boards Network manager/Core Teams NHS Infrastructure (money) Done quickly and in parallel—for patients and staff (April –October 2007)

  19. Resources • Stage 1- Allocated to all networks asap • Core team (5 posts) ~ 300k pa per CLRN) £200k (07/08) • Per capita allocation (~1.5M per 2M pop) £750k (07/08) • Research management and governance • Research Infrastructure (includes sessions for clinicians) • Does NOT include non-staff clinical support costs (eg radiology, pharmacy and pathology) • 2006/7 pro-rata allocation based on roll-out • In addition to existing transition funding and TCRN funding • Stage 2 – from April 2008 • Activity based • Increased operational staff • Non-staff support costs • Rising to £90M pa … any necessary increases thereafter

  20. NIHR Portfolio for CRN (Provisional)

  21. PROPOSALS FOR SUPPORTING TOPICS WITHIN CCRN NHS INFRASTRUCTURE an example for Respiratory Health STUDIES Lead Functions Local INDUSTRY LINKS; ADOPTION; ADVICE; FEASIBILITY. National

  22. Figure 2 STUDIES NHS INFRASTRUCTURE Local National PORTFOLIO GENERATION IN ACADEMIC SECTOR Portfolio Development FUNDERS PROVIDE PRIORITIES AND SUPPORT Short Term Groups

  23. How will non-medicines paediatric research (NMPR) be represented within CCRN? • Currently NMPR is not recognised within UKCRC/UKCRN topic lists. • Concerns about this have been expressed locally and nationally. • UKCRN have asked MCRNCC if they wish to become involved in the co-ordination of NMPR studies across England. • This has been discussed at the MRCN Executive and Board who were unanimous in support of this proposal. • MCRN will ensure that their core business continues to get high priority, but can use the infrastructure and links developed to support all paediatric research.

  24. Proposal to Co-ordinate NMPR • Currently under discussion between MCRN, UKCRN and DH. • Actively being discussed at local level, and with national organisations: RCPCH, Children’s Research Alliance, APA, BAPs etc. • CLRN Directors will be involved in identifying level of interest and strengths in their CLRN. • Full discussion planned at a meeting in 2008, to include CLRN representatives and all stakeholders.

  25. Conclusions • Pace of change is very rapid. • Huge opportunities – need to be recognised and grasped. • Broad support but an anxious research management community. • Could become the best whole system for clinical research in the world. • For paediatrics, we must build on achievements and position ourselves well for the future. • All help and advice gratefully received

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