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Clinical Research in Scotland
John Savill
University of Edinburgh
and
Chief Scientist Office
Scottish Government Health Directorates
Scotland
•  5.3M people
•  National Health Service
•  Stable population
•  “Sick man of Europe”; high rates
of “western” diseases
Scotland: The Clinical
Research Engine
•  One-eighth of UK researchers
•  One seventh of UK funding
•  Outperformed rest of UK on quality
in RAE 2008
•  Core strengths in clinical
translational research
Scottish Clinical
Research Strengths
•  Neuroscience – stroke, schizophrenia,
bipolar, cognitive decline;
•  Inflammatory diseases – rheumatoid, liver
cirrhosis, lung fibrosis and emphysema;
•  Metabolic/vascular diseases – diabetes,
obesity, coronary artery diseases;
•  Cancer – solid tumours and leukaemias
•  Reproductive disorders – menorrhagia, pre-
eclampsia and infertility
Scotland’s Advantages in
Clinical Research
•  Electronic Records Linkage – for 5.3M people
with a single, coherently structured health
provider.
•  Collaboration - Aberdeen
- Dundee
- Edinburgh
- Glasgow
(St. Andrews)
Electronic Records Linkage
in Scotland
•  Unique identifier: CHI number
•  NHS Information and Statistics Division
(probability matching)
•  30-year coded historical datasets
(admissions, prescribing etc.)
•  Disease registers (Diabetes – Andrew
Morris)
•  15-year follow up of WOSCOPS
Routine data for long term
follow up
• Primary prevention of
heart disease
• Screened 81,000 men
• 6,595 participated
• Role of statins in
CVD management
Log-rank p=<0.0001
Placebo
Pravastatin
WOSCOPS 15 year follow up
Data mining in action
Original
trial
Ford et al, N Eng J Med (2007) 357 1477-86
Scotland: Major Collaborations in
Clinical Research
•  Generation Scotland £10M (CSO/SE)
•  Translational Medicine Research Collaboration
£50M (Wyeth/SE)
•  Scottish Clinical Research Excellence Develop-
ment Scheme £4M pa (CSO/NES/SFC)
•  SINAPSE Imaging Consortium £40M (SFC £7M)
•  Scottish Health Informatics Platform £5M
(Wellcome etc.)
•  Scottish Translational Medicine Training Initiative
£3M (Wellcome)
•  Scottish Academic Health Sciences Collaboration
£15M pa (CSO)
Research infrastructure
MRI
PET/SPECT
EEG/MEG
Shared expertise
Greater critical mass
Training
Cohesion
Optimise clinical trials
Industry
SINAPSE
Chief Scientist Office Budget
2008/09
Total: £66.9M
Research budget: £17.5M
- Grants
- Units
- Capacity Building and other programmes
Support for Science: £37.4m
Research Networks: £10M
Investing in Research,
Improving Health
Its ambition is to
“place Scotland at the international
forefront of clinical translational
research and the development of
systems medicine.”
Focus
•  Patient benefit
•  Improved population
health
•  Economic benefit
4 Main Aims
•  Securing benefit
•  Improving Population Health
•  Valuing and Investing in NHS Research
•  Building and Sustaining Skills
Dundee
Clinical Research Centre
Health Informatics Centre&Memo
CRUK laboratories
Glasgow
BHFGCRC
Biomedical Research Centre
Integrated CRF
Beatson Oncology Centre
Sackler Institute
Edinburgh
Wellcome CRF
Institute Med Cell Biol
Aberdeen
IMS
IAHS
CRF
• Purpose built basic biomedical research institutes.
• Integrated general clinical research facilities.
Regulatory
affairs
VPN
Affiliated
centres
+ +
The Translational Medicine Research Collaboration “Shared
goals, complimentary strengths, shared risk and reward”
Umbrella agreement for shared and protected IP
The Scottish Academic Health
Sciences Collaboration
(SAHSC)
SAHSC: NHS Scotland’s new platform to
support research for patient benefit and
foster related economic development.
NHS Boards Universities
Grampian Aberdeen
Greater Glasgow & Clyde Glasgow
Lothian Edinburgh
Tayside Dundee
Scottish Enterprise
Aims of the SAHSC
•  Speeding the development of stratified/
personalised medicine;
•  Doubling the number of patients
participating in clinical studies by 2012;
•  Increasing competitive clinical research
funding from UK sources by ~£25M pa; and
•  Developing mutually beneficial partnerships
with Biotech and Pharma.
To improve the health and wealth of
the Scottish population by:-
The SAHSC Platform
•  Clinical Research Facilities (nurses,
physiologists)
•  Clinical Research Imaging Centres
(radiographers, physicists)
•  Clinical Trials Units (pharmacists,
statisticians)
•  Biorepositories (pathology staff)
•  Electronic Records Research Portals
(informaticians)
Health Boards and CSO work together to
reconfigure by 2012 ~£15M pa of funding to
underpin ~280 fulltime posts in coordinated:
SAHSC: Serving Scotland as a whole
• 4 Nodes: cluster of Boards
local universities
• Networks: cancer
dementia
diabetes
medicines for children
mental health
primary care
stroke
Scotland: Addressing the
needs of Pharma and Biotech
•  Single point of contact: National Research Scotland
Co-ordinating Centre, register of experts
•  Feasibility: Information and Statistics Division
•  Recruitment/ “Consent for Consent”: Primary Care
Research Network
•  “Cooksey 2”: Scottish Medicines Consortium
•  Clusters: e.g. Edinburgh BioQuarter
NEJM Oct 2007
National Approaches to Clinical Trials
•  Meetings
•  Mail
•  Media
McKinstry B, Hammersley V, Daly F, Sullivan F
Recruitment and retention in a multicentre randomised controlled trial in Bells palsy: A case study
BMC Medical Research Methodology 2007, 7:15 doi:10.1186/1471-2288-7-15
Scotland: Addressing the
needs of Pharma and Biotech
•  Single point of contact: National Research Scotland
Co-ordinating Centre, register of experts
•  Feasibility: Information and Statistics Division
•  Recruitment/ “Consent for Consent”: Primary Care
Research Network
•  “Cooksey 2”: Scottish Medicines Consortium
•  Clusters: e.g. Edinburgh BioQuarter
SCRM
Royal
Infirmary
Queen’s Medical
Research Institute
Chancellor’s
Building
Little France Site/Edinburgh BioQuarter
The Scottish Academic Health
Sciences Collaboration
*Broad, powerful, high quality
*Embedded in conducive NHS system
*Informatics as a USP
*Collaboration and partnership add value
*Keen to work with Biotech and Pharma
*Obvious UK cluster

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John Savil - Clinical Research in Scotland - 2010

  • 1. Clinical Research in Scotland John Savill University of Edinburgh and Chief Scientist Office Scottish Government Health Directorates
  • 2. Scotland •  5.3M people •  National Health Service •  Stable population •  “Sick man of Europe”; high rates of “western” diseases
  • 3.
  • 4. Scotland: The Clinical Research Engine •  One-eighth of UK researchers •  One seventh of UK funding •  Outperformed rest of UK on quality in RAE 2008 •  Core strengths in clinical translational research
  • 5. Scottish Clinical Research Strengths •  Neuroscience – stroke, schizophrenia, bipolar, cognitive decline; •  Inflammatory diseases – rheumatoid, liver cirrhosis, lung fibrosis and emphysema; •  Metabolic/vascular diseases – diabetes, obesity, coronary artery diseases; •  Cancer – solid tumours and leukaemias •  Reproductive disorders – menorrhagia, pre- eclampsia and infertility
  • 6. Scotland’s Advantages in Clinical Research •  Electronic Records Linkage – for 5.3M people with a single, coherently structured health provider. •  Collaboration - Aberdeen - Dundee - Edinburgh - Glasgow (St. Andrews)
  • 7. Electronic Records Linkage in Scotland •  Unique identifier: CHI number •  NHS Information and Statistics Division (probability matching) •  30-year coded historical datasets (admissions, prescribing etc.) •  Disease registers (Diabetes – Andrew Morris) •  15-year follow up of WOSCOPS
  • 8. Routine data for long term follow up • Primary prevention of heart disease • Screened 81,000 men • 6,595 participated • Role of statins in CVD management
  • 9. Log-rank p=<0.0001 Placebo Pravastatin WOSCOPS 15 year follow up Data mining in action Original trial Ford et al, N Eng J Med (2007) 357 1477-86
  • 10. Scotland: Major Collaborations in Clinical Research •  Generation Scotland £10M (CSO/SE) •  Translational Medicine Research Collaboration £50M (Wyeth/SE) •  Scottish Clinical Research Excellence Develop- ment Scheme £4M pa (CSO/NES/SFC) •  SINAPSE Imaging Consortium £40M (SFC £7M) •  Scottish Health Informatics Platform £5M (Wellcome etc.) •  Scottish Translational Medicine Training Initiative £3M (Wellcome) •  Scottish Academic Health Sciences Collaboration £15M pa (CSO)
  • 11. Research infrastructure MRI PET/SPECT EEG/MEG Shared expertise Greater critical mass Training Cohesion Optimise clinical trials Industry SINAPSE
  • 12. Chief Scientist Office Budget 2008/09 Total: £66.9M Research budget: £17.5M - Grants - Units - Capacity Building and other programmes Support for Science: £37.4m Research Networks: £10M
  • 13. Investing in Research, Improving Health Its ambition is to “place Scotland at the international forefront of clinical translational research and the development of systems medicine.”
  • 14. Focus •  Patient benefit •  Improved population health •  Economic benefit
  • 15. 4 Main Aims •  Securing benefit •  Improving Population Health •  Valuing and Investing in NHS Research •  Building and Sustaining Skills
  • 16. Dundee Clinical Research Centre Health Informatics Centre&Memo CRUK laboratories Glasgow BHFGCRC Biomedical Research Centre Integrated CRF Beatson Oncology Centre Sackler Institute Edinburgh Wellcome CRF Institute Med Cell Biol Aberdeen IMS IAHS CRF • Purpose built basic biomedical research institutes. • Integrated general clinical research facilities. Regulatory affairs VPN Affiliated centres
  • 17. + + The Translational Medicine Research Collaboration “Shared goals, complimentary strengths, shared risk and reward” Umbrella agreement for shared and protected IP
  • 18. The Scottish Academic Health Sciences Collaboration (SAHSC)
  • 19. SAHSC: NHS Scotland’s new platform to support research for patient benefit and foster related economic development. NHS Boards Universities Grampian Aberdeen Greater Glasgow & Clyde Glasgow Lothian Edinburgh Tayside Dundee Scottish Enterprise
  • 20. Aims of the SAHSC •  Speeding the development of stratified/ personalised medicine; •  Doubling the number of patients participating in clinical studies by 2012; •  Increasing competitive clinical research funding from UK sources by ~£25M pa; and •  Developing mutually beneficial partnerships with Biotech and Pharma. To improve the health and wealth of the Scottish population by:-
  • 21. The SAHSC Platform •  Clinical Research Facilities (nurses, physiologists) •  Clinical Research Imaging Centres (radiographers, physicists) •  Clinical Trials Units (pharmacists, statisticians) •  Biorepositories (pathology staff) •  Electronic Records Research Portals (informaticians) Health Boards and CSO work together to reconfigure by 2012 ~£15M pa of funding to underpin ~280 fulltime posts in coordinated:
  • 22. SAHSC: Serving Scotland as a whole • 4 Nodes: cluster of Boards local universities • Networks: cancer dementia diabetes medicines for children mental health primary care stroke
  • 23. Scotland: Addressing the needs of Pharma and Biotech •  Single point of contact: National Research Scotland Co-ordinating Centre, register of experts •  Feasibility: Information and Statistics Division •  Recruitment/ “Consent for Consent”: Primary Care Research Network •  “Cooksey 2”: Scottish Medicines Consortium •  Clusters: e.g. Edinburgh BioQuarter
  • 24. NEJM Oct 2007 National Approaches to Clinical Trials
  • 25. •  Meetings •  Mail •  Media McKinstry B, Hammersley V, Daly F, Sullivan F Recruitment and retention in a multicentre randomised controlled trial in Bells palsy: A case study BMC Medical Research Methodology 2007, 7:15 doi:10.1186/1471-2288-7-15
  • 26. Scotland: Addressing the needs of Pharma and Biotech •  Single point of contact: National Research Scotland Co-ordinating Centre, register of experts •  Feasibility: Information and Statistics Division •  Recruitment/ “Consent for Consent”: Primary Care Research Network •  “Cooksey 2”: Scottish Medicines Consortium •  Clusters: e.g. Edinburgh BioQuarter
  • 28. The Scottish Academic Health Sciences Collaboration *Broad, powerful, high quality *Embedded in conducive NHS system *Informatics as a USP *Collaboration and partnership add value *Keen to work with Biotech and Pharma *Obvious UK cluster