CLRN aims

1. Comprehensive Local Research Networks and NCRN:- Working in partnershipProf JN PrimroseDirector, Hampshire and the Isle of Wight CLRN

2. 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.

3. Comprehensive Local Research Networks:How did it all happen?

4. 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~£ 2M Comprehensive Research Network 2007~£90M+

5. TCRN Coordinating Centres Professor Paul WallaceDeputy Director for Primary Care Professors Janet Darbyshire & Peter SelbyUKCRN and NIHR CCRN CC and PCRN Professor Gary FordDirector, Stroke Research Network Professor David Cameron Director, National Cancer Research Network Professor Ros SmythDirector, Medicines for Children Research Network Professor Til WykesDirector, Mental Health Research Network Professors Martin Rossor and Ian McKeithCo-Directors, Dementias and Neurodegenerative Diseases Research Network Professor Des JohnstonDirector, Diabetes Research Network

6. 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+

7. NIHR 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 • All healthcare • From April 2009 will be a main route for NHS service support for clinical research (with CRFs, ECMCs,TPs)

9. What is a Comprehensive Local Research Network? • Primary vehicle for NHS infrastructure (service support) • Primary, secondary and tertiary care and Mental Health • 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.

10. 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

11. Bottom line • CLRN funding replaces most of the previous Culyer (R&D) funding which went to (the bottom line of) NHS Trusts • After Transitional Funding disappears (2008-09 is last year) no other major source of funding to support R&D • Funding can be used only to support NIHR Portfolio studies • Own account and local charity funding does not attract CLRN service support • Money follows (Portfolio) research for first time

12. Personal research background • Clinical and translational cancer research • 3 recent or ongoing major HTA grants mainly in cancer as Chief Investigator including the FACS Trial (colorectal cancer follow up) • 3 recent or ongoing CRUK grants as Chief Investigator (including BILCAP and New EPOC) • Collaborator on several other research programmes and TSC and DMEC chairs for a number of studies • Past member of CTAAC, current member of CTRC, Vice Chair of TRICC

13. Why did I want to become a CLRN Director? • Clinical research has become total misery • Increase in bureaucracy especially after advent of European Clinical Trials Directive • Multiple barriers to completing clinical trials especially Trust R&D • One study (FACS) needed separate application to every acute and primary care Trust in England • CLRN presents the best opportunity to cut through the current barriers

14. BILCAP Trial 12.7 months/centre set up time: Delay mainly Trust R&D

15. Some personal observations as a CLRN Director • Everything I always believed about the unaccountability of R&D funding (Trust’s finance bottom line) is true • Even when research activity is examined much is not of high quality • However, some high quality research is not “Portfolio” • The capacity of individuals within some Trust R&D offices is very poor • In the short term the core CLRN Team may have to do more centrally in networks

16. Partnership with NCRNWhat benefits will it bring? • Make provision of service support transparent and easy • Performance manage support for clinical studies • Unblocking the blocks eg pharmacy, radiology, pathology etc • Performance manage NHS support for clinical studies • Streamline regulation, governance, reporting and approvals • Strengthen research collaboration with industry • CSP (“central sign off”) • Pay for clinical sessions for key staff eg consultant PAs

17. Banding of studies The number of patients expected to be recruited per consultant PA over a 40 week year

18. What problems remain? • CSP! (Will it work, will Trusts pay any attention to process?) • Treatment costs • Can R&D bureaucracy be overcome easily? • Will activity related funding really remain uncapped? • Industry • System is too complicated

19. Conclusions • Best opportunity to encourage cancer (and other) research by making funding follow the research • A large amount of change rapidly • Could become the best whole system for clinical research in the world • Bureaucratic limitations remain a real challenge j.n.primrose@soton.ac.uk