Comprehensive Local Research Network & NCRN Working in Partnership

1. Comprehensive Local Research Network&NCRNWorking in Partnership Dr David Jackson Clinical Lead for Research YCRN Co-director WYCLRN NCRN Roadshow, Leeds, 5th June 2008 West Yorkshire Comprehensive Local Research Network

2. Development of research networks • Policy • Background • CLRN • Structure • Functions • Networks in Yorkshire • Partnership with CLRN • Opportunities & threats • Ongoing challenges West Yorkshire Comprehensive Local Research Network

3. Background • The NHS Cancer Plan 2000 • NCRN 2000 • YCRN 2002 “Allow conduct of clinical trials and other well designed research, to enhance the quality, speed, co-ordination of clinical research and integration with cancer care” • Best Research for Best Health 2006 • NIHR & UKCRN • Comprehensive Local Research Networks • The Cancer Reform Strategy 2007 West Yorkshire Comprehensive Local Research Network

4. Best Research for Best Health • To create a health research system in which the NHS supports outstanding individuals, working in world class facilities, conducting cutting edge research, focused on the needs of patients and the public • To achieve this we will: • Establish the NHS as an internationally recognised centre of research excellence • Attract, develop and retain the best research professionals to conduct people-based research • Commission research focused on improving health and care • Strengthen and streamline systems for research management and governance • Act as sound custodians of public money for public good West Yorkshire Comprehensive Local Research Network

5. Research networks FIRST PHASE NCRN 2000~£20M MHRN2003~£ 4M SECOND PHASE (TCRN’s) MCRN, DRN, SRN, DeNDRoN 2005~£16M THIRD PHASE Primary Care Research Network 2007~£ 2MComprehensive Research Network 2007~£90M+ West Yorkshire Comprehensive Local Research Network

6. West Yorkshire Comprehensive Local Research Network

7. Health Research Categories West Yorkshire Comprehensive Local Research Network

8. NCRNAccrual to NCRN Portfolio studies across the UK 30 25 20 15 10 Participants Recruited 5 0 Jan/Feb Mar/Apr May/Jun Jul/Aug Sep/Oct Nov/Dec Jan/Feb 05 05 05 05 05 05 06 MHRN Impact of MHRN Involvement on Study Accrual MHRN involvement in the project commenced in June 05. First recruitment recovery plan 19 September 2005 Recruitment plan updated February 2006 Comparison of recruitment into Myeloma VII (pre-NCRN) and Myeloma IX (post-NCRN) Impact of MHRN on Study Accrual The main aim of research networks: increasing recruitment into research studies West Yorkshire Comprehensive Local Research Network

9. West Yorkshire Comprehensive Local Research Network

10. UK Clinical Research Network • To provide the NHS infrastructure to support clinical research across all areas of disease and clinical need • To help streamline the research management function for UKCRN portfolio studies supported by the networks • To do this by: • Establishing a managed set of clinical research networks • Identifying a national portfolio of studies • Funding infrastructure (NHS support costs) for portfolio studies • Supporting the research management of these studies West Yorkshire Comprehensive Local Research Network

11. 25 Comprehensive Local Research Networks (CLRNs)

12. UKCRN Portfolio “Clinical trials & other well designed studies” • Elligibility • Funding • NIHR, other government, non-commercial partners • Open competition, peer review • Clear value to the NHS • Strategic direction for research • Industry sponsored • Overseas government • Other high quality studies (e.g. EORTC) • Formal adoption process • National database & recruitment data West Yorkshire Comprehensive Local Research Network

13. WYCLRN Portfolio • April 2007 to present • 121 studies • 303 study/site combinations • 2116 patients recruited • Of these: • NCRN portfolio • 86 studies • 1014 patients recruited West Yorkshire Comprehensive Local Research Network

14. Research Funding • ARCO 2005 • Attributing revenue costs of externally-funded non-commercial research in the NHS • Research costs • Data collection & analysis • Research funding body (NIHR, Charity) • Treatment costs • Commissioning arrangements • NHS support costs • Additional tests, inpatient care • nursing support, research professionals • R&D support funding CLRN West Yorkshire Comprehensive Local Research Network

15. CLRN funding • All healthcare – primary, secondary, tertiary, MH • NHS service support costs • Infrastructure & running costs • Research staff • Research active clinicians • Research Management & Governance • Streamline across network • CSP / research passports • UKCRN portfolio • Support for Topic Clinical Research Networks • Cancer & Stroke • Primary Care Research Network Replaces Culyer funding West Yorkshire Comprehensive Local Research Network

16. Bottom line • CLRN funding replaces previous Culyer (R&D) funding • went to (the bottom line of) NHS Trusts • Only source of funding to support NHS R&D • After Transitional Funding disappears • Only to support UKCRN Portfolio studies • Not own account and local charity funded • Money follows (Portfolio) research for first time West Yorkshire Comprehensive Local Research Network

17. West Yorkshire Comprehensive Local Research Network

18. What is a Comprehensive Local Research Network? • Primary vehicle for NHS infrastructure (service support) • From April 2009 • Clinical Director and Network Manager and core team • Network Executive & Network Board • Host organisation • Research management & governance 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 West Yorkshire Comprehensive Local Research Network

19. West Yorkshire Comprehensive Local Research Network

20. Resources Year 1 (2007/08) - Allocated to all networks asap • Core team (5 posts) ~ 300k pa per CLRN • Per capita allocation (~1.5M per 2M pop) • Research management and governance • Research Infrastructure staff (includes sessions for clinicians) • In addition to existing transition funding and TCRN funding Year 2 (2008/09) • Additional activity based resources • Increased operational staff and non-staff costs • Rising to £90M pa … any necessary increases thereafter West Yorkshire Comprehensive Local Research Network

21. West YorkshireComprehensive Local Research Network West Yorkshire Comprehensive Local Research Network

22. West Yorkshire Comprehensive Local Research Network

23. Key Acute NHS Trust R&D Departments Primary Care Trust R&D Departments Mental Health R&D Consortium Arrow indicated sites covered RM&G Structure West Yorkshire Comprehensive Local Research Network

24. Resources • 08/09 • Core team £413K • Clinical directors, management team • Per capita £2,250K • Activity based £1,424K • FSF £112K £4,199K West Yorkshire Comprehensive Local Research Network

25. Operational plan • Work in progress! • RM&G infrastructure • Options appraisal • Research infrastructure • Service support costs • “Unblocking blocks” • Funding distributed to Trusts • Activity based – specialty level • Areas for development • Performance management West Yorkshire Comprehensive Local Research Network

27. Core Team 7.6 WTE Research Team 8.1 WTE 2.1 WTE 1.1 WTE 2.3 WTE 0.9 WTE 1.6 WTE 2.7 WTE YCRN • Budget • £826K • Staff • 26.4 WTE • Non-YCRN • 56.4 WTE

28. YCRN Functions • National portfolio • Local implementation • Approval processes • Local R&D • Ethics • Training & education • GCP, communication • Recruitment • Follow-up

29. Recruitment 15.2% 16.3% 13.8% 12.2% • Vacancy control • Patchy portfolio coverage • Slow approval processes • Service support blocks

30. YCRN & WYCLRN West Yorkshire Comprehensive Local Research Network

31. N&EY & NL CLRN WY CLRN West Yorkshire Comprehensive Local Research Network

32. Opportunities for YCRN • Streamlining regulatory processes • Nationally – CSP • Network – RM&G structure • Transparent funding for service support • Radiology, pharmacy, pathology • National costing models • “Unblocking blocks” • Additional funding for research infrastructure • Building on strengths – activity based funding • Quick wins to increase recruitment • Reward for research active clinicians • Strengthen links with industry West Yorkshire Comprehensive Local Research Network

33. Perceived threats • Lag in new funding stream • Destabilising infrastructure • Research team • R&D structure • “Rich” specialty • Inequality between different CLRNs • Duplication of effort between YCRN & CLRN West Yorkshire Comprehensive Local Research Network

34. Sharing good practice Awareness of “blocks” Devolved research teams Line management Training & education Professional development Network identity Identify new areas for investment Opportunities for CLRN West Yorkshire Comprehensive Local Research Network

35. Challenges • RM&G bureaucracy • Trust statutory obligations • Treatment costs • Commissioners • Activity based funding • Costing models • Real time • Accuracy of data • Rapid implementation & transiton West Yorkshire Comprehensive Local Research Network

36. Conclusions West Yorkshire Comprehensive Local Research Network

37. CLRN aims • Ensure patients & healthcare professionals can take part in and benefit from clinical research  • Improve quality, speed and coordination of clinical research by removing barriers to research within the NHS • Streamline and performance manage NHS support for clinical studies • Unify and streamline administrative procedures associated with regulation, governance, reporting and approvals • Strengthen research collaboration with industry • Further integrate health research and patient care. West Yorkshire Comprehensive Local Research Network

38. Shared aims • Huge opportunities • Transparent funding • Activity based • Streamlined RM&G • Active involvement in CLRN • Executive • Board West Yorkshire Comprehensive Local Research Network