Warwick CTU
10th Anniversary Presentation
Professor Tom Walley
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
MRC
DH
Research spend 2004/2005 - UKCRC analysis
Combined MRC and DH spend
Research 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
DoH funding not
• In the past RAE has emphasised
well regarded
– funding from Research Councils
– publication in high citation journals
• Strong bias
– towards basic/translation research
– against applied research
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
Drivers for change
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”
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
Faculty
Investigators &
Senior
Investigators
Associates
Trainees
Infrastructure
Universities
Research
Clinical Research
Networks
NHS Trusts
Research Projects
& Programmes
Patients
&
Public
Clinical Research
Facilities & Centres
Research
Governance
Systems
Research Units &
Schools
Research
Information
Systems
Systems
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:
Published in NEJM
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
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: 12/127/126
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
Clinical Trials Landscape 2015
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…?
NIHR Active Randomised Controlled Trials – Nov 2014
Centre
CCF
NETSCC
TCC
Mean
Planned
Planned
£/
Recruitment Recruitment participant
Number
of Trials
Total Research
Funding
Mean Trial
Cost
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
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
Clinician Scientist
13
12,573,283
£967,176
N/A
N/A
N/A
Fellowships
NIHR/HEE CAT
Fellowships
NIHR/HEE
Healthcare
Science
47
14,317,510
£397,709
N/A
N/A
N/A
7
842,193
£280,731
N/A
N/A
N/A
2
0
N/A
N/A
N/A
N/A
69
27,732,986
656,057
941
£1,295
Programme
Total
827
£990,907,679 £1,218,829
Comparison with Previous Data Set
MAY 2014
Number
Programme
of Trials
NOVEMBER 2014
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)
Clinical Trials and Warwick CTU
• Success in increasing trials numbers/recruitment/funding
• Success in using trials to change NHS practice and culture
• Happy Birthday!
Research Funding by HRCS Health Category (Apportioned)
£ million
% Active RCTs by Organisation Type
% Active RCTs by Organisation Type
Top 10 Organisations by Total Research Funding
University of Oxford
Total
Number of
Research
RCTs
Funding
£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
Organisation
Top 10 Organisations by Number of RCTs
Total
Research
Funding
Number of
RCTs
£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
Organisation
University College London
Mapping of Active RCTs by Organisation
(Total Research Funding)
Warwick CTU
• 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
% 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