Clinical Research in Yorkshire: Infrastructure & management

1. Clinical Research in Yorkshire:Infrastructure & management Dr David Jackson Clinical Lead for Research YCRN Co-director WYCLRN Yorkshire Palliative Medicine Regional Learning Group April 2008

2. Yorkshire Cancer Research Network

3. Background • The NHS Cancer Plan 2000 • NCRN 2001 • 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 • UKCRN • Comprehensive Local Research Networks • The Cancer Reform Strategy 2007

5. Population 2.6M Yorkshire Cancer Network service Acute Trusts Cancer centre Cancer Units Unit alliances Yorkshire Cancer Research Network

6. NCRN 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 • Cancer • Prevention; screening

7. YCRN Portfolio

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

9. YCRN funded staff Core Team 7.6 WTE Research Team 9 WTE 1.9 WTE 1.1 WTE 2.3 WTE 0.9 WTE 1.6 WTE 2.7 WTE • Budget • £730K • YCRN staff • 26.6 WTE • Non-YCRN • 59.8 WTE

10. YCRN funded staff • Non-surgical oncology • Haematology • Breast surgery • Genetics • Psycho-oncology • Paediatrics • Palliative care

11. Recruitment

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

13. Strategic Plan • Strategic development of portfolio • Network site-specific groups • Portfolio development officers • Specialist clinical advisors • Hard-to-recruit areas • Streamline regulatory processes • Devolved teams across network • Integrated within local teams • Developing & maintaining YCRN identity • Training & Education • Service User Partnership Group • Funding • Commissioning • CLRN – service support costs

14. West Yorkshire Comprehensive Local Research Network

15. West Yorkshire Comprehensive Local Research Network

16. West Yorkshire Comprehensive Local Research Network

17. 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 Recruitment plan updated February 2006 First recruitment recovery plan 19 September 2005 MHRN involvement in the project commenced in June 05. 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

18. 25 Comprehensive Local Research Networks CLRNs

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

20. Aim of UKCRN • 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

21. 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) • NHS support costs • Additional tests, inpatient care • nursing support, research professionals • R&D support funding CLRN • Treatment costs • Commissioning arrangements West Yorkshire Comprehensive Local Research Network

22. Comprehensive Local Research Networks • NIHR / UKCRN • 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

23. Health Research Categories West Yorkshire Comprehensive Local Research Network

24. West Yorkshire Comprehensive Local Research Network

25. Resources • 08/09 • Core team £413K • Clinical directors, management team • Per capita £2,250K • Activity based £1,424K • FSF £112K • Operational plan • Work in progress! • Sessional payments • RM&G infrastructure • Research infrastructure • Service support costs • “Unblocking blocks” West Yorkshire Comprehensive Local Research Network

26. Summary • YCRN • Established & successful • Need to maintain & increase recruitment • WYCLRN • Rapid implementation & transition • Streamlined RM&G • Transparent funding streams • Strategic development of local portfolio • Strengths & weaknesses • Unblocking blocks • Local knowledge • Activity based funding