The Role of Health Research Wales in supporting Industry Research in Betsi Cadwaladr University Health Board (BCUHB)
International Clinical Trials Day 20th May 2014
Presented by Rebecca Burns, Health Research Wales, Industry Manager
The Role of Health Research Wales in supporting Industry Research in Betsi Cadwaladr University Health Board (BCUHB)
1. The Role of Health Research Wales in supporting
Industry Research in BCUHB
International Clinical Trials Day 20th May 2014
Rebecca Burns - Health Research Wales Industry Manager
2. Changing Environment
Weak Economy
Reduce cost of care
and system
inefficiencies
Aging Population
Higher patient
volumes, more chronic
care, new illness,
health lifecycle
management
In the UK, the NHS faces a projected spending gap of £30bn a
year by 2021, as the number of older people with multiple long-
term conditions such as cancer, diabetes and heart disease rises
inexorably
3. Commercial Research – NHS Drivers
• Full Cost Recovery from Industry
• Capacity Building
• Drug/Device Development privately financed
• Development in Wales/UK good for employment
& economy
• Access to cutting edge treatments & technologies
• Driver to improve Best Practice
• Aids recruitment & retention of specialist staff
• “Together for Health NISCHR 2011- 2016 ” KPIs
4. The Pharmaceutical Industry is the
Leading Investor in R&D in the UK
Since 2000 the UK
has been losing
out to global
competitors
5. Percentage of patient enrolment into studies
Perception of the UK:
Slow (site selection, study set up and delivery)
Poor at achieving recruitment to time and target
Expensive (compared emerging
markets such as India)
6. What is Health Research Wales?
• Recommendation made by Industry to establish separate
brand identity for commercial clinical research in Wales
• Industry facing brand of Wales
One stop source of information and support for
industry
Portal for industry to access NHS Wales
Services to support the set-up and management of
commercial research studies
• Communication vehicle to promote Wales and demonstrate
Wales’ clinical research successes
21. Feasibility
the Industry Perspective
Global Competition to place a study in the UK
Two key factors to
the decision:
How quick it is to
get permissions
granted
Are there
sufficient willing
patient volunteers to
take part
22. Feasibility
Clinician Perspective
National Competition to get the study in own
health board
Fast return of EOI (Expressions of Interest)
Successful site selection visit
Record of successful recruitment to and
completion of study within the agreed times
Realistic & accurate estimate of potential recruits
Be aware of service support available & discuss
protocol requirements with departments
Assess what research support could be needed &
Involve NISCHR CRC & Health Research Wales
28. Why do Commercial research?
• Its much easier to be part of than to start on my own
• Remuneration to the organisation
• Opportunity to treat some difficult cases, particularly in
one trial as I ran out options from the formulary
• It’s a scientific stimulus as NHS work is mainly service
• Opportunity for publication
• Access to and experience of using new or novel
treatments or devices
• Cost savings
• Raises the profile of department or service
• Funding other research Interests
29. Some feedback
I can’t thank you enough for your help and
support in completing the necessary forms for
the * study. I simply couldn’t have done it
without your help as I was on the verge of
giving up. I am sure you know that one of the
main obstacles for research in DGH is the
lack of this specialist support. I sincerely
hope that this new service will develop to
ensure that research will not be exclusive to
large institutions only.
30.
31. Small Business Research Innovation Awards (SBRI )
£3m available to fund innovative solutions to public sector challenges
• Funded by the Welsh Government and the Technology Strategy Board,
£3m available for new projects.
• The programme aims to drive innovation in the four areas including Life
Sciences and Health
• Public sector organisations, looking for new and novel solutions to
challenges they face, can apply for a share of this new fund.
• The identified challenge is then turned into an open competition for new
technologies and ideas from businesses.
• The Programme aims to boost the research and development industry,
increase commercialisation of new technologies and create jobs and
wealth.
Hinweis der Redaktion
Together for health welsh Governments 5 year delivery plan to 2016 for improving health and healthcare in Welsh NHS
NISCHR Key Indicator ↑ Commercial research by 5%
Nesta (formerly NESTA, National Endowment for Science, Technology and the Arts) is an independent charity that works to increase the innovation capacity of the UK.
The organisation acts through a combination of practical programmes, investment, policy and research, and the formation of partnerships to promote innovation across a broad range of sectors.
Nesta was originally funded by a £250 million endowment from the UK National Lottery. The endowment is now kept in trust, and Nesta uses the interest from the trust to meet its charitable objects and to fund and support its projects.
Industry Task & Finish Group (Autumn 2011)
31 members: Industry (15), NHS (7) HEI (5) WG (4)
Eight recommendations accepted by NISCHR
Commitment within NISCHR WG Industry policy
Industry Advisory Group (current)
Sub-group oversees implementation to ensure it meets industry needs
Microvisk needed to run two clinical trials which would form the final part of their regulatory subbmission to obtain CE marking for their device.
For this they would need clinical partners and access to patients on anticoagulant therapy.
Examples
Microvisk
Fungal nail infection
Gweepi
Meeting for T&CS Academic board
Costing using the Industry costing template for medical devices.
This is a national UK approved template that enables a clear and consistent approach to costing.
This gives reassurance to both Industry and the NHS that costs correctly charged and reimbursed.
Companies are looking for sites with the right study population and clinicians with research experience or support with the right facilities.
Uk Divisions of global pharma have to compete with International colleagues to run a trial in the UK rather than in low cost economies such as Eastern Europe and the Far East
Turn around with health research Wales 10 days sometimes less.
Lab setup
GCP training for research staff
Recruitment strategy
Risk Assessment
IRMER
IRAS
29 - 42
2
1 partnering neurocare
4
5
Contact Health Research Wales for a suitable contract