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