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

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

4. UK Clinical Research Network Comprehensive Research Networks

5. 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

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

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

8. FIRST PHASE NCRN2000~£20M MHRN2003~£ 4M SECOND PHASE (TCRN’s) MCRN, DRN, SRN, DeENDroN 2005~£16M THIRD PHASE Primary Care Research Network2007~£ 2M Comprehensive Research Network2007~£90M+ Introduction of Clinical Research Networks

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

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

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

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

13. 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)www.ukcrn.org.uk

14. 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

15. MCRN Portfolio studies

17. 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

18. 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 for clinicians, nurses, data managers, secretarial. - infrastructure in primary care. - diagnostics and service costs. - running costs.

19. 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)

21. 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

22. NIHR Portfolio for CRN (Provisional) TopicRecruiting Blood13 Cardiovascular208 Congenital Disorders1 Ear0 Eye25 Infection47 Inflammatory and Immune34 Injuries and Accidents9 Metabolic and Endocrine15 Musculoskeletal67 Neurological81 Oral and Gastrointestinal50 Renal and Urogenital19 Reproductive Health & Childbirth 60 Respiratory47 Skin16 Generic Health Relevance99 GRAND TOTAL1124

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

24. 25 CLRNs CSG Short Term Ad Hoc Groups CSG Longer Term Standing Groups Collaborating Network Group (10-12 members) Appointed Chair Portfolio Development FUNDERS PROVIDE PRIORITIES AND SUPPORT Short Term Groups PORTFOLIO GENERATION IN ACADEMIC SECTOR NHS INFRASTRUCTURE STUDIES Figure 2 Local National

25. 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.

26. 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.

27. 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