1. Warwick CTU 10 th Anniversary Presentation Professor Tom Walley

2. Clinical Trials Landscape Funders: Public: MRC, HTA programme Charities: CRUK, Wellcome, BHF Problems Decline in clinical research community Decline in infrastructure for clinical research Complex regulatory environment Need to recognise Industry R&D needs in the UK Not yet realising the Potential of a single National Health Service

3. MRC DH Research spend 2004/2005 - UKCRC analysis

4. Combined MRC and DH spend Research spend 2004/2005 - UKCRC analysis

5. Research Assessment Exercise Periodic process of evaluating research quality (leading to reassigning £££ - in theory) Assessment by panels of peers, based on publications, programmes, funding In the past RAE has emphasised –funding from Research Councils –publication in high citation journals Strong bias –towards basic/translation research –against applied research DoH funding not well regarded Applied research is UK oriented, less international – less cited journals

6. Result of previous RAEs Universities disinvesting –from training medical academics –from involvement in health services research and even clinical research (lab studies easier & more prestigious) Reduced pool of experienced researchers interested in HTA type study Increasing separation between aims of universities and of the NHS

7. Drivers for change “There is now a substantial gulf between basic discoveries and converting such discoveries into innovations that directly benefit patients or prevent disease”

8. Drivers for change “The UK has the opportunity, through the NHS, to transform the efficiency and effectiveness of clinical trials conducted here” Improving National Health; Increasing National Wealth

9. “Establish the NHS as the world leader in contributions to clinical research” Drivers for change

10. NHS R&D Strategy To create a health research system in which the NHS supports outstanding individuals, working in world-class facilities, conducting leading-edge research, focused on the needs of patients and the public

11. National Institute for Health Research Infrastructure Clinical Research Facilities & Centres Clinical Research Networks Research Research Projects & Programmes Research Governance Systems Research Information Systems Systems Patients & Public Universities Investigators & Senior Investigators Associates Faculty Trainees Research Units & Schools NHS Trusts

12. Warwick CTU Since CTU Support Funding commenced in September 2008: Warwick CTU has reported involvement with 38 NIHR trials. This amounts to £50,599,358 in successful trial funding gained from NIHR Programmes. Funded trials range over five programmes: 26 trials - HTA 7 trials - RfPB 3 trials - PGfAR 1 trial - EME 1 trial - HS&DR

13. Warwick CTU Out of the 24 units who currently receive CTU Support Funding: Number 2 - income received from NIHR projects. Number 2 - maximum reported offset (as a percentage of CTU Support Funding award). Number 1 - number of Outline proposals submitted in the last reporting period (2013-14).

14. Warwick CTU

15. Published major projects supported by Warwick CTU: HTA Programme, Ref: 06/04/01 OSCAR: A randomised controlled trial and cost effectiveness analysis of high frequency oscillatory ventilation against conventional artificial ventilation for adults with acute respiratory distress syndrome. Total Project Cost – £2,704,668 EME Programme, Ref: 09/800/21 BALTI-2: The B2 Agonist Lung Injury Trial 2. Total Project Cost - £1,491,150 Published in NEJM

16. Warwick CTU PARAMEDIC Trial – 2014 Trial of the Year Selected by the Society for Clinical Trials at 36 th Annual Meeting. Funded by HTA Programme (project ref: 07/37/69). Total Project Cost £2,176,422. Chief Investigator – Professor Simon Gates. Study team comprising of trial investigators, trial manager, paramedic & PPI representative. Published in The Lancet.

17. Warwick CTU Current NIHR funded projects supported by Warwick CTU: HTA Programme, Ref: 12/127/126 PARAMEDIC 2: Randomised placebo controlled trial of adrenaline for out of hospital cardiac arrest. Total Project Cost - £2,751,277 HTA Programme, Ref: 11/25/03 Mammo-50: Mammographic surveillance in breast cancer patients aged 50 years or older. Total Project Cost - £2,107,443

18. Funders NIHR, CRUK Others… Positives Funding, research infrastructure, CTUs, academic and policy recognition Problems NHS engagement – XSTC, clinician time, etc (slightly less) complex regulatory environment Funding…? Clinical Trials Landscape 2015

19. CentreProgramme Number of Trials Total Research Funding Mean Trial Cost Planned Recruitment Mean Planned Recruitment £ / participant CCF PGfAR 145294,078,872£2,028,130160,2061,187£1,709 RfPB 18446,269,218£247,42925,843138£1,790 329340,348,090 NETSCC EME 6578,269,970£1,204,15327,408489£2,460 HS&DR 1714,737,516£866,91312,819986£879 HTA 310495,479,403£1,598,321405,2711,437£1,112 PHR 3734,339,714£928,10024,5101,021£909 429622,826,603 TCC Clinician Scientist 1312,573,283£967,176N/A Fellowships 4714,317,510£397,709N/A NIHR/HEE CAT Fellowships 7842,193£280,731N/A NIHR/HEE Healthcare Science 20N/A 6927,732,986 Total 827£990,907,679£1,218,829656,057941£1,295 NIHR Active Randomised Controlled Trials – Nov 2014

20. Comparison with Previous Data Set MAY 2014NOVEMBER 2014 Programme Number of Trials Total Research Funding Planned Recruitment Number of Trials Total Research Funding Planned Recruitment EME 54 £62,798,79020,527 6578,269,97027,408 HSDR 13 £13,173,60311,625 1714,737,51612,819 HTA 270 £433,274,292525,201 310495,479,403405,271 PHR 27 £21,719,90820,318 3734,339,71424,510 RfPB 183 £43,776,88429,534 18446,269,21825,843 PGfAR 148 £279,151,182210,318 145294,078,872160,206 TCC 49 £25,977,427N/A 6927,732,986N/A TOTALS744 £879,872,086 817,523827 990,907,679656,057

21. Research Funding by HRCS Research Activity Group DH

22. Research funding by HRCS Research Activity Code Group 6

23. No. Active RCTs by HRCS Research Activity Code Group 6

24. No. Active RCTs by HRCS Health Category (Apportioned)

25. Mapping of Active RCTs by Organisation (No. Trials)

26. Success in increasing trials numbers/recruitment/funding Success in using trials to change NHS practice and culture Happy Birthday! Clinical Trials and Warwick CTU

28. Research Funding by HRCS Health Category (Apportioned) £ million

29. % Active RCTs by Organisation Type

31. Organisation Total Research Funding Number of RCTs University of Oxford£80,862,94824 University College London£48,459,87432 South London & Maudsley NHS Foundation Trust£41,150,90527 University of Birmingham£30,547,15324 Imperial College London£28,008,36922 Oxfordshire CCG£25,881,3305 Newcastle University£25,821,84523 University of Leeds£21,303,73816 University of Nottingham£19,145,16515 King's College London£18,471,03618 Top 10 Organisations by Total Research Funding

32. Organisation Total Research Funding Number of RCTs University College London£48,459,87432 South London & Maudsley NHS Foundation Trust£41,150,90527 University of Oxford£80,862,94824 University of Birmingham£30,547,15324 Newcastle University£25,821,84523 Imperial College London£28,008,36922 Nottingham University Hospitals NHS Trust£15,054,52919 King's College London£18,471,03618 University of Leeds£21,303,73816 The University of Manchester£15,288,59516 Top 10 Organisations by Number of RCTs

33. Mapping of Active RCTs by Organisation (Total Research Funding)

34. Unit has been in receipt of NIHR CTU Support Funding since 1 September 2008. Current contract runs until 31 August 2018. Consistent growth and improvement in NIHR applications and projects. Annual funding has increased from £250K to £550K. Second largest annual funding amount in 2014-15. Warwick CTU

37. % Active RCTs by Funding Programme

38. Total Research Funding by Programme £ million

39. Total Planned Recruitment by Programme

40. % Active RCTs by Trial Type