Industry Research in the NHS the UK Perspective

1
Industry Research in the NHS the UK Perspective

• Dr Mark Lewis
• DH Advisor
• on behalf of
• Dr Louise Wood
• Head of Industry/RD Relations, DH

2
Mission and Objectives of DH RD

• In the context of Research as a front line
  service in the NHS - Secretary of State John
  Reid, March 2004 the mission is
• To provide evidence on which to base
  improvements in the health of individuals and the
  management of disease
• and this will be achieved by
• Supporting the UK science base
• Researching areas of NHS priority need

3
The need for more industry-related RD

• Attacking the root causes of disease vs
  palliative interventions and symptomatic relief
• Reduced efficacy of existing root-cause
  interventions eg bacterial resistance
• Achieving more satisfactory treatment regimens
• Evaluation of emerging technologies
• Treatment of emerging new diseases

4
The joint industry-public sector analysis of
clinical research

• PICTF (since 2000)
• BIGT (2003)
• AMS (2003)
• RPBWP (2004)
• HITF (2004)

5
Strategic objective of the DH role in commercial
RD

• An optimised clinical research environment which
  attracts inward investment from innovative
  industries delivering improved national
  healthcare and public health and increasing
  national wealth on a sustained basis
• The NHS Plan
• Protect patients, avoid delaying research
• NHS has a major role in ensuring the UK remains
  an attractive place for industry

6
Whats in it for patients and the NHS?

• The possibility of much better treatments
• Change to patterns of treatment
• Early access to innovative therapies
• Career development for individual clinicians and
• Better trained clinicians

7
How does industry define an attractive trial
location?

• A track record of performance
• Speed
• Quality
• Cost
• International acceptability

8
Improvements in the NHS research environment

• NHS RD Partnership with the Pharmaceutical
  Industry
• DH/ABPI model Clinical Trial Agreement(s) and
  initiatives like the Costing guidance
• Research Governance Framework
• Ethics Committee arrangements
• Process is incomplete

9
As recommended in RPBWP.
10
Background to the UKCRC
11
Guiding principles of UKCRC

• Engage stakeholders through consultation and
  negotiation rather than representation
• Adopt a solutions-based rather than
  recommendations-based approach to problems
• Build on what is already working well
• Improve communication but not at the cost of
  momentum
• Add value by not taking on issues easily tackled
  by a single partner organisation
• Independence is key!

12
UKCRC Workstreams
13
UK CRC Clinical Networks
Cancer research networks
?
14
UKCRC Network Structure

• Managed networks
• Leadership by national subject specialist and/or
  local enthusiast
• Shared processes and paperwork including SOPs for
  GCP, pharmacovigilance etc
• National Data capture system
• Network of regulatory expertise and advice
• Training and support

15
Similarities to and differences from NCRN

• Recognise that cancer was a different challenge
• Aim is to increase activity of high quality
  clinical research but
• Customised targets for each area rather than
  numbers recruited
• Recognise challenges different within each
  topic-specific network
• Infrastructure is open to industry right from the
  start

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MRC CTU
Generic
Liverpool
??
17
Network models
Co-ordinatingCentre
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Experimental Medicine

• NHS RD looks to its UKCRC partners for a lead
• Developing co-ordinated initiative for 2005
• Build up a national framework for experimental
  medicine around an expanded network of Wellcome
  Trust Clinical Research Facilities (CRFs)
• Not just about infrastructure, but people,
  training, research programmes etc
• Commitment to pay NHS costs of agreed CRFs

19
Clinical Research Funding
Extra diagnostics Beds Governance
Management
Leadership - protocol - sponsorship - data
collection - analysis -write up
Equipment Space Trained staff IM T
20
Other themes

• National programme for IT (NPfIT) links
• recruitment
• modelling trials feasibility in UK etc
• Wanless issues
• slow adoption of technologies
• effects of demographic changes on NHS needs and
  costs
• HITF
• national innovation centre

21
Success through Collaboration

• Public with science
• Private with public sectors
• Government with all stakeholders
• Academe with service
• Patients with clinicians
• And barriers removed with incentives in place

22
In summary

• Industry needs the NHS for access to patients
  the NHS needs industries outputs
• DH is facilitating the symbiotic relationship
• Good progress made but still barriers to overcome
  in buttressing the UKs position as a host of
  clinical research
• Major role envisaged for UKCRC
• NHS staff to be incentivised, rewarded and
  recognised for research achievements,
  irrespective of the funder