NCRN Local Research Networks

1. A Managed Cancer Research Network – Achievements and the FutureMatt CooperAssistant DirectorNCRN Coordinating Centre

2. Established in 2001, Funded by DH & integrated with NHS cancer service networks “to benefit patients by improving the coordination, integration, quality, inclusiveness and speed of cancer research”. NCRN Local Research Networks

3. Cancer patient recruitment in England (as a % of cancer incidence)

4. Annual Recruitment of Cancer Patients to NIHR CRN studies in England

6. same players same supporters same stadium same rules same game

7. Whole System Working

8. Innovation • Mount Vernon – Use of volunteer staff • North East London – First Patient Review • Kent & Medway – Costing work (ETC) flagged as national exemplar • Surrey, West Hampshire & Sussex – Pilot, informing patients upfront what data would be required at follow up • North Trent – Use of bank staff to support data collection during times of pressure. • Gt. Mids – tool for sharing best practice and tailoring training programmes for the network

9. Number of studies open to recruitment each year

10. Number of new studies added to the portfolio each year

11. The chart (note the logarithmic scale) shows that the increase in recruitment since 2005-06 is predominantly due to the expansion in the portfolio but with that has come many more studies recruiting fewer patients each year: 2005/06: Median 24.5 recruits/study, 32% (77/238) studies recruited 12 or fewer participants/year. 2012/13: Median 16 recruits/study, 44% (282/637) studies recruited 12 or fewer participants/year.

12. Broad Portfolio

13. Head & Neck Cancer

14. RT Patients entered into trials Patients recruited into Radiotherapy studies

16. Number of Open Studies by main topic (UK-wide)

17. 2012/13 portfolio – commercial/ non-commercial portfolio by division

18. 2012/13 portfolio – observational/interventional study design by division

19. 2012/13 portfolio – studies occurring in one LCRN only by division

20. Industry • High priority for NCRN, NIHR, DH, Government • Expanded CC team to encourage and manage • Three models: • Industry-sponsored, NIHR portfolio eligible • Conventional academic/industry collaborations • Special partnership/alliance arrangements

21. Commercial studies

22. % Industry Studies Recruiting to Time and Target studies closing with ≥100% planned patients in ≤100% planned time studies closing within 10% of the planned time/number target

23. Headlines • 494 studies to date from 191 companies • 176 studies open to recruitment in 2012/13 • 76% studies closing in 2012/13 reaching at least 90% recruitment target • 11 “first global” patients since end 2012 (4 this year)

24. Alliances with Industry • Special partnership with companies • Underpinned memorandum of understanding • Access to pipeline drugs • Explore non-core disease areas & combinations • Investigator Sponsored Studies • Standard upfront agreed costs • Collaborative workshops

25. Industry Alliance Programme • AZ Alliance • Partnership established 2009 • Phase II multi-centre randomised trials • 5 joint AZ/NCRN workshops (>100 EOIs) • 32 trials to date: • 5 completed recruitment • 11 recruiting • 6 in set-up • 10 under discussion/grant application • GSK Alliance • Partnership established 2010 • Phase II multi-centre randomised trials • 1 joint GSK/NCRN workshop • 4 trials to date: • 2 recruiting • 2 in set-up • Future • Discussions in progress with • Roche

26. Alliance Studies by CTU • ICR • CASPS -open • TOPARP open • Turner multi drug (at CTAAC) • Oxford • DOC-MEK - closed • RADVAN – open • PACMEL – open (GSK) • Tayside • STAKT - to open Sept • Brighton • PAKT - in set up • Barts • ZEBRA – open • MANTA – in set up • Leicester • Fennell - with AZ? • Birmingham • SCART - open • STOMP - open • Liverpool • VIP - open • Uveal melanoma (at CTAAC) • Southampton • PROCAID - in set up • Cardiff • TOUCAN - open • FOLFERA - closed • PIN - in set up • FAKTION – in set up • Breast – Jones/Breseford(at CTAAC) • Edinburgh • ARISTACAT - open • COSAK - closed • UCL • ABC-03 - closed • SaPPrOC-closed • DORIC -closed • ABC-05- (at CTAAC) • Glasgow • CIRCCa - closed • SAPROCAN – open • Brain – Chalmers (at CTAAC) • PLUTO – open (GSK) • TBC • Andrew Tutt - UCL? • Jon Wadsley – Leeds? • MRC • Focus 4D – Open Oct

27. Win – Win • Patients Gain: • Access to new therapies at an earlier time point, particularly in less common indications • Company Gains: • External advice and critique of programmes • Ability to evaluate compound potential through broader programmes and low resource in Phase I & II studies • Efficiencies through cross-project, portfolio level agreements standard contracts, ways of working, common understanding • Academia Gains: • Access to range of compounds at earlier, more scientifically-interesting stage of early development • Standard funding and support

28. FOCUS4

29. Myeloma UK Clinical Trial Network Progress Completed Trials • MUKone, a Phase II study of bendamustine recruited to time and target • Analysis is underway and publication planned for end 2013 Trials Open to Patient Recruitment MUKthree, a Phase I/IIa study of CHR-3996 in combination with tosedostat MUKfive, a Phase II study of carfilzomib in comparison to bortezomib MUKsix, a Phase I/IIa study of panobinostat Trials in Set-Up MUKfour, a Phase II study of vorinostat Trials in Discussion MUKseven, a Phase II study of pomalidomide MUKx, a Phase II study of MLN97089

30. Trials Acceleration ProgrammeTAP Existing 9 TAP funded trials opento recruitment or in active set up: • MAJIC • RAvVA • CALiBRe • IcICLLe • BREVITY • CyCLLe • ElAstic • MATCHPOINT • ROMAZA Two new trials awarded: • LEN/AZA • RomiCar

31. capture, storage & curation of data sharing, analysis & visualisation of data transparent data, usable at increased frequency Big - NASA produce 1 terabyte of info every hour – would need 50,000 trees to store in print form

32. NIHR CRN Data • 637,974 – New participants in research in 2012/13 • 1,592 New studies 2012/13 • 744 Life Science Industry partners • Time to NHS Permission from 110 days in 2010/11 to 28 days in Q1 of 2012/13

33. Open Data Platform: Managing the Business Intelligence

34. NCPES • National Cancer Patient Experience Survey collects responses from: • All adult patients (aged 16 and over) with a primary diagnosis of cancer who have been admitted to hospital as inpatients, or who were a day case patient, and have been discharged between 1st September 2012 and 30th November 2012. • Third national survey (First in 2010) • Research questions introduced for the first time in 2011-12 cycle

35. Research Questions: • 2012-13 questions • 29. Patient has seen information about cancer research (New) • Have you seen information (such as leaflets, posters, information screens etc.) about cancer research in your hospital? • 85% of patients said they had seen information about research; 15% had not. • West Midlands average – 85% • 30. Taking part in cancer research • Since your diagnosis has anyone discussed with you whether you would like to take part in cancer research? • 32% of patients said that taking part in research had been discussed with them; 68% said it had not. • West Midlands average 27% (range 16-42%) • 2012 33%

36. Research Questions: • 2012-13 questions • 31. Did those asked take part in cancer research (New) • If yes, did you then go on to take part in cancer research? • 64% of those patients who said they were asked, said they went on to take part in cancer research; 36% did not. • West Midlands average – 62%

37. Gt. Mids Q 29 Q 30 Q 31 2013 2013 2012 2013 • National 85% 32% 33% 64% • MSFT 81% 27% 25%77% • UHNS 88% 27% 29% 65% • RWT 86% 33% 32% 65% • DGFT 83% 24% 29%71% • S&TH 82% 27% 27% 59% W. Midsave.84% 28% 28%62%

38. JNCI 99 (6) 420-421, 2007

39. Recruitment in 2012/13 78,324 participants in total recruited into the NIHR-portfolio of cancer studies in England 49,347 cancer (& pre-malignant) patients (21.3% of incident cases) More than a 5 fold increase from 2001