This document discusses clinical research in Scotland. It notes that Scotland has a population of 5.3 million served by a single national health service, with strengths in areas like neuroscience, cancer, and metabolic diseases. Scotland performs well in clinical research relative to its size, with one-eighth of UK researchers and funding. It has advantages like electronic health records linking for the entire population and collaboration between research centers. Major research initiatives and infrastructure are described, with a focus on improving population health and developing partnerships with industry.

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

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

27. SCRM
Royal
Infirmary
Queen’s Medical
Research Institute
Chancellor’s
Building
Little France Site/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