Warwick CTU 10th Anniversary Presentation

Professor Tom Walley

Clinical Trials LandscapeFunders: • 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

MRC DH

Research spend 2004/2005 - UKCRC analysis

Combined MRC and DH spendResearch spend 2004/2005 - UKCRC analysis

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

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

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”

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

RESEARCH FOR PATIENT BENEFIT WORKING PARTY

FINAL REPORT

“For us, science and research constitute a front-line service, as they too, reduce distress

and pain and save lives”.

(Dr John Reid, Secretary of State for Health, 22 March 2004)

“Establish the NHS as the world leader in contributions to clinical research”

Drivers for change

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

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

InvestigatorsAssociates

Faculty

Trainees

Research Units & Schools

NHS Trusts

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

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).

Warwick CTU

Warwick CTU

Published major projects supported by Warwick CTU:

HTA Programme, Ref: 06/04/01OSCAR: 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: 09/800/21BALTI-2: The B2 Agonist Lung Injury Trial 2.Total Project Cost - £1,491,150

Published in NEJM

Warwick CTU

PARAMEDIC Trial – 2014 Trial of the Year

• Selected by the Society for Clinical Trials at 36th 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.

Warwick CTU

Current NIHR funded projects supported by Warwick CTU:

HTA Programme , Ref: 12/127/126PARAMEDIC 2: Randomised placebo controlled trial of adrenaline for out of hospital cardiac arrest.Total Project Cost - £2,751,277

HTA Programme, Ref: 11/25/03Mammo-50: Mammographic surveillance in breast cancer patients aged 50 years or older.Total Project Cost - £2,107,443

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

Centre ProgrammeNumber of Trials

Total Research Funding

Mean Trial Cost

Planned Recruitment

Mean Planned

Recruitment £ /

participant

CCF  

PGfAR 145 294,078,872 £2,028,130 160,206 1,187 £1,709

RfPB 184 46,269,218 £247,429 25,843 138 £1,790

329 340,348,090        

NETSCC    

EME 65 78,269,970 £1,204,153 27,408 489 £2,460

HS&DR 17 14,737,516 £866,913 12,819 986 £879

HTA 310 495,479,403 £1,598,321 405,271 1,437 £1,112

PHR 37 34,339,714 £928,100 24,510 1,021 £909

429 622,826,603        

TCC    

Clinician Scientist 13 12,573,283 £967,176 N/A N/A N/A

Fellowships 47 14,317,510 £397,709 N/A N/A N/A

NIHR/HEE CAT Fellowships

7 842,193 £280,731 N/A N/A N/A

NIHR/HEE Healthcare Science

2 0 N/A N/A N/A N/A

69 27,732,986        

Total 827 £990,907,679 £1,218,829 656,057 941 £1,295

NIHR Active Randomised Controlled Trials – Nov 2014

Comparison with Previous Data Set

MAY 2014 NOVEMBER 2014

ProgrammeNumber of Trials

Total Research Funding

Planned Recruitment

Number of Trials

Total Research Funding

Planned Recruitment

EME 54 £62,798,790 20,527 65 78,269,970 27,408

HSDR 13 £13,173,603 11,625 17 14,737,516 12,819

HTA 270 £433,274,292 525,201 310 495,479,403 405,271

PHR 27 £21,719,908 20,318 37 34,339,714 24,510

RfPB 183 £43,776,884 29,534  184 46,269,218 25,843

PGfAR 148 £279,151,182 210,318 145 294,078,872 160,206

TCC 49 £25,977,427 N/A 69 27,732,986 N/A

 

TOTALS 744 £879,872,086 817,523 827 990,907,679 656,057

Research Funding by HRCS Research Activity Group

Research funding by HRCS Research Activity Code Group 6

No. Active RCTs by HRCS Research Activity Code Group 6

No. Active RCTs by HRCS Health Category (Apportioned)

Mapping of Active RCTs by Organisation (No. Trials)

• Success in increasing trials numbers/recruitment/funding

• Success in using trials to change NHS practice and culture

• Happy Birthday!

Clinical Trials and Warwick CTU

Research Funding by HRCS Health Category (Apportioned)

£ million

% Active RCTs by Organisation Type

% Active RCTs by Organisation Type

OrganisationTotal

Research Funding

Number of RCTs

University of Oxford £80,862,948 24

University College London £48,459,874 32

South London & Maudsley NHS Foundation Trust £41,150,905 27

University of Birmingham £30,547,153 24

Imperial College London £28,008,369 22

Oxfordshire CCG £25,881,330 5

Newcastle University £25,821,845 23

University of Leeds £21,303,738 16

University of Nottingham £19,145,165 15

King's College London £18,471,036 18

Top 10 Organisations by Total Research Funding

OrganisationTotal

Research Funding

Number of RCTs

University College London £48,459,874 32

South London & Maudsley NHS Foundation Trust £41,150,905 27

University of Oxford £80,862,948 24

University of Birmingham £30,547,153 24

Newcastle University £25,821,845 23

Imperial College London £28,008,369 22

Nottingham University Hospitals NHS Trust £15,054,529 19

King's College London £18,471,036 18

University of Leeds £21,303,738 16

The University of Manchester £15,288,595 16

Top 10 Organisations by Number of RCTs

Mapping of Active RCTs by Organisation (Total Research Funding)

• 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

Warwick CTU

Warwick CTU

% Active RCTs by Funding Programme

Total Research Funding by Programme

£ million

Total Planned Recruitment by Programme

% Active RCTs by Trial Type

% Active RCTs by Trial Type