Recent Developments in the UK Clinical Research Network UKCRN

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Recent Developments in the UK Clinical Research
Network (UKCRN)

• Jonathan Gower Assistant Director (CCRN)
• Sheffield Health and Social Research
• Consortium Annual Conference 2007
• Sheffield
• 22 November 2007

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Recent Developments in the UK Clinical Research
Network (UKCRN)

• Background and purpose
• Comprehensive Local Research Networks
• Update on implementation
• Work in progress

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Recent Developments in the UK Clinical Research
Network (UKCRN)

• Background and purpose
• Comprehensive Local Research Networks
• Update on implementation
• Work in progress

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UKCRN Overall Aim

• To develop UK-wide infrastructure embedded within
  the NHS to support high quality research across
  all areas of health and clinical need funded by
  both commercial and non-commercial funders

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Clinical Research Networks

• PURPOSE
• Benefits for Patients and Public--health --both
  through improving the process of care and new
  evidence for better care
• Excellence and Innovation in Clinical Research
• Links with Industrywealth

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A Whole System
Network Infrastructure in the NHS
Industry Funders
Academic Funders
INDUSTRY FUNDERS
Patients
Portfolio- Clinical Studies Groups
Clinical Trials Units/ RDSUs/RDS
NATIONAL COORDINATING CENTRE(S)
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UKCRN

• FIRST PHASE
• NCRN 200020M
• MHRN 2003 4M
• SECOND PHASE (TCRNs)
• MCRN, DRN, SRN, DeENDroN 200516M
• THIRD PHASE
• Primary Care Research Network 2007
  2M Comprehensive Research Network 200790M

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TCRN Coordinating Centres
Professor Paul WallaceDeputy Director for
Primary Care
Professors Janet Darbyshire Peter SelbyUKCRN
CC and PCRN
Professor Gary FordDirector, Stroke Research
Network
Professor David Cameron Director, National
Cancer Research Network
Professor Ros SmythDirector, Medicines for
Children Research Network
Professor Til WykesDirector, Mental Health
Research Network
Professors Martin Rossor, Director, and Ian
McKeith Co-Director, Dementias and
Neurodegenerative Diseases Research Network
Professor Des JohnstonDirector, Diabetes
Research Network
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What impact are we trying to achieve?
Comparison of recruitment into Myeloma VII
(pre-NCRN) and Myeloma IX (post-NCRN)
Some of the Reasons for poor recruitment Poor
feasibility checks Patchy approvals
processes Slow recruitment of staff Limited time
for research Limited access to patients

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NIHR Comprehensive Clinical Research Network
(CCRN)

• to provide the NHS infrastructure to support
  clinical research-25 CLRNs
• streamline the research management
  function--reduce bureaucracy where possible
• all healthcare, complete geographical coverage
• from April 2009 will be a main route for NHS
  service support for clinical research (with
  CRFs,ECMCs,TPs)

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Recent Developments in the UK Clinical Research
Network (UKCRN)

• Background and purpose
• Comprehensive Local Research Networks
• Update on implementation
• Work in progress

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What is a Comprehensive Local Research Network?

• Primary vehicle for NHS infrastructure
• Primary, secondary and tertiary care
• Clinical Director and Network Manager
• Network Executive and Network Board
• Host organisation
• Research management for portfolio
• A typical CLRN
• - NHS staff management, sessions for
• investigators, nurses, data managers,
  secretarial
• - infrastructure in primary care
• - diagnostics and service costs
• - running costs

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Resources

• Stage 1- Allocated to all networks asap
• Core team (5 posts) 300k pa per CLRN) 200k
  (07/08)
• Per capita allocation (1.5M per 2M pop) 750k
  (07/08)
• Research management and governance
• Research Infrastructure
• Does NOT include non-staff clinical support costs
  (eg radiology, pharmacy and pathology)
• 2006/7 pro-rata allocation based on roll-out
• In addition to existing transition funding and
  TCRN funding
• Stage 2 from April 2008
• Activity based
• Increased operational staff
• Non-staff support costs
• Rising to 90M pa any necessary increases
  thereafter

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Recent Developments in the UK Clinical Research
Network (UKCRN)

• Background and purpose
• Comprehensive Local Research Networks
• Update on implementation
• Work in progress

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CLRN- A balance between national standards and
consistency and local ownership and control!

• Geography-functional clinical research
  entities(25/25)
• Host Organisations(25/25)
• Clinical Directors(25/25)
• Network Boards(25/25)
• Network manager/Core Teams(19/25)
• NHS Infrastructure(beginning-funded!)
• Portfolio
  baseline (Dec 2007)
• Specialist
  Network Groups
• Done quickly and in parallelfor patients
• and staff

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Overview of recent developments

• CCRN shape developing
• core personnel groups initial plans
• National networks of expertise
• Active engagement across all professions and
  health sectors
• National developments informed by existing good
  practice
• Ongoing review of developments is key
• Pace of development is (still) rapid

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Recent Developments in the UK Clinical Research
Network (UKCRN)

• Background and purpose
• Comprehensive Local Research Networks
• Update on implementation
• Work in progress
• Portfolio
• Research Management
• Speciality Network Groups
• Funding

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UKCRN PortfolioCLRN funding can only be used to
support studies on the NIHR portfolio

• A national register of all eligible studies
• NIHR portfolio in England eligibility defined
  by DH
• Portfolios in Northern Ireland, Scotland and
  Wales
• UK-wide working within portfolios
• Includes multi-centre and single centre studies
• Includes commercial and non-commercial studies
• Basic requirements funded in open national
  competition and with independent peer review
• Under development

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Recent Developments in the UK Clinical Research
Network (UKCRN)

• Background and purpose
• Comprehensive Local Research Networks
• Update on implementation
• Work in progress
• Portfolio
• Research Management
• Speciality Network Groups
• Funding

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Research Management

• Research passports
• National Launch Event on 30.10.07
• Training for CLRN Leads planned for November
• 1 year roll-out after Launch
• Multi-site Working for NHS staff
• CLRN provides opportunity to put SLA in place
  between Trusts
• Requires changes to Trust policies

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Central Sign-Off (CSO)

• NHS acceptance
• NHS organisations are the key to delivering CSO
• CSO Unit (UKCRN CC) and CLRNs can
• - conduct excellent process
• - pay for all staff involved
• - deliver meticulous work in a timely way
• - be subject to independent audit
• BUT
• NHS organisations need to provide a signatory
  person promptly for system to work
• - 2 weeks
• - come rain or shine
• Requires confidence and communication
• Not all will wish to do so

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Recent Developments in the UK Clinical Research
Network (UKCRN)

• Background and purpose
• Comprehensive Local Research Networks
• Update on implementation
• Work in progress
• Portfolio
• Research Management
• Speciality Network Groups
• Funding

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UKCRC Health Research Categories
To be modified mainly by sub-divisions
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Network Groupssubject specific aspects of CCRN
NHS INFRASTRUCTURE
INDUSTRY STUDIES
an example for Respiratory Health
Lead
Functions
INDUSTRY LINKS ADOPTION ADVICE FEASIBILITY.
Local
National
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Recent Developments in the UK Clinical Research
Network (UKCRN)

• Background and purpose
• Comprehensive Local Research Networks
• Update on implementation
• Work in progress
• Portfolio
• Research Management
• Speciality Network Groups
• Funding

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Funding

• Undertaking mapping exercises across the CLRNs to
  determine what portfolio studies are ongoing
  within constituent organisations and outline
  levels of activity FIND, FIT and FUND
• CDs developing operational plans which identify
  topic strengths and opportunities in the CLRN to
  determine the way in which the 07/08 per capita
  funding will be distributed across the CLRN,
  including allocation of sessional support for
  clinicians of all professions.
• Per capita funding supports activity up to a
  certain level
• Work on costing clinical research
• Activity-based funding allocation system for
  08/09

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Impact

• A large amount of change rapidly creating
  uncertainty
• National funding is directed to demonstrably high
  quality research work
• A dynamic system support channelled to where it
  is needed
• Acknowledgement of individual contributions to
  research projects and sessions paid for
• More rapid set-up and better delivery of research
  studies
• Better access for patients to research studies
• Better access to patients for research studies
• Access to high quality research management
  support for ALL Trusts
• A database of national activity with high
  quality, up-to-date information
• A framework which enables performance
  measurement, management and reporting
• Could become the best whole system for clinical
  research in the world!

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• Jonathan Gower Assistant Director (CCRN)
• j.gower_at_ukcrn.org.uk
• 0113 392 4484
• www.ukcrn.org.uk