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Essex & Hertfordshire CLRN Demystified… Oksana Hoile Senior Manager. Clinical research: National Challenges. "Problems cannot be solved at the same level of awareness that created them". Albert Enstein. NIHR Clinical Research Network (NIHR CRN). NHS Clinical Research Networks: Cancer

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nihr clinical research network nihr crn
NIHR Clinical Research Network (NIHR CRN)

NHS Clinical Research Networks:

  • Cancer
  • Dementia and Neurodegenerative Diseases (DENDRON)
  • Diabetes (DRN)
  • Medicines for Children
  • Mental Health (MHRN)
  • Primary Care (PCRN)
  • Stroke (SRN)
  • Comprehensive Clinical Research Network (CLRN)
what is the nihr national portfolio
What is the NIHR (‘national’) Portfolio?
  • All networks implement aspects of the national R&D strategy
  • ALL support only the ‘portfolio’ studies
  • The national research portfolio is a national register of ‘eligible’ studies
      • In England ‘eligibility’ of studies defined by Department of Health
      • Emphasis on national competitive funding
  • Includes multi-centre and single centre studies
  • Includes commercial and non-commercial studies
  • Similar portfolios in Northern Ireland, Scotland and Wales
  • UK-wide working within portfolios
what is clrn
What is CLRN?
  • Part of the family of networks under the umbrella of the National Institute for Health Research (NIHR)
  • Specific responsibility for ensuring high quality research of relevance and importance to the NHS and its users can proceed in the NHS
  • 17 NHS trusts (hospitals, primary care, mental health) in Essex & Hertfordshire are member of the CLRN
which studies are supported by clrn
Which studies are supported by CLRN?
  • All health studies that have been through rigorous reviews and adopted onto the NIHR Portfolio of Research (‘portfolio research’)
  • £6.4 million annual budget
  • from April 2009 CLRN becomes the main route for accessing NHS R&D Support Funding
what is funded by clrn
What is funded by CLRN?
  • NHS staff time to participate in the portfolio research, e.g. investigators, trial officers, research nurses
  • Local NHS support services, e.g. pharmacies, X-ray departments, laboratories – all staff and services contributing to research
  • Also, we undertake regulatory checks of all research protocols; and train staff so they conduct research safely and effectively
local specialty groups lsg
Local Specialty Groups (LSG)
  • 26 Specialty Groups nationally (most do not have a single research funder)
  • A new concept:
    • focus on practical aspects of conducting studies (local NHS, staff, patients and carers)
    • In Essex & Herts, 12 LSGs were set up in 2008/9
    • 4 more to be set up in 2009/10: Gastroenterology, Metabolic & Endocrine Diseases, Dermatology, Public Health
  • Interactions could be mutually beneficial to both, NHS and academic sectors
coordinated system for nhs permission csp
Coordinated System for NHS Permission (CSP)
  • A standardised process for undertaking research governance checks
  • Research Governance checks divided into global (completed once only) and local (completed for each site)
  • CLRN provide assurance to Trusts that these checks have been done according to ‘best practice’
  • Up to Trusts to give the final permission for research to go ahead
what are we trying to achieve
What are we trying to achieve?
  • Patients have opportunity to take part in good quality studies
  • Researchers have a single point of entry for a portfolio study governance approval
  • All Trusts receive CLRN service and expert advice
  • Single set of procedures for research governance within the CLRN
  • Those contributing to the portfolio studies are adequately resourced

Studies are quickly and effectively approved, well governed and achieve recruitment targets…

what does a cluster team do
What does a Cluster Team do?
  • Directly communicate with trusts, investigators and their teams, support services
  • Deals with local R&D issues
  • Coordinate System for NHS Permission (CSP)
  • ‘Hands on’ study set up, support and performance management – BEST FRIEND!
  • Implement Good HR Practice (Research Passport)
  • Encourage NIHR Faculty Membership uptake
  • Regulatory and Governance Advice Service to trusts
  • Ensure study recruitment data is collected and collated
  • Ensure resources are allocated where they are needed most
  • Provide support to Leads of Local Specialty Groups
electronic communication across clrn
Electronic communication across CLRN

The Challenge - working across many Trusts and research teams

The Solutions - secure electronic web environment:

  • use existing NHS email functionality
  • CSP – web-based portal
  • SharePoint – web based portal system for storage of information
  • External Websites (CLRN & NIHR)
Operating Framework for the NHS

in England 2009/10:

‘the national ambition is to double the number of patients taking part in clinical trials and other well-designed research studies within 5 years’

research study feasibility
Research Study Feasibility
  • Getting away from allocating ‘X number per research site’ to realistic numbers possible to recruit
  • Ensure ‘feasibility’ has a built-in validation process
    • How to asses if the site has a genuine interest in a study?
    • Who is best placed to undertake a feasibility?
    • How best to describe results of feasibility?
  • Assessment of each research site capabilities
  • Understanding local populations, burden of diseases, patient/clinical flows, staff competencies, patient screening opportunities
support for staff involved in research
Support for staff involved in research
  • Development of career structure for local research active staff
  • Flexible working for research staff through different employment opportunities
  • Mentorship and support for professional development schemes
  • Clinical Research Leadership Programme

To conclude

  • CLRNs pave the way to potentially the best ‘whole system’ for supporting clinical research in the world - a great opportunity to make this work!
  • A large volume of challenges & opportunities!
  • Broad support locally but a very anxious research and R&D community
  • Antagonism, bureaucracy and unrealistic expectations will remain big challenges for a while yet
  • All help and advice will be gratefully received!
thank you for listening
Thank YOU for listening!

Contact Details:

Essex & Hertfordshire CLRNCS-09a, Primary Care Centre, Turner Rd, Colchester, Essex, CO4 5JR

E-mail:[email protected]

[email protected]

Tel : 01206 286773

Adam Young Clinical Director, WHHT

Caroline Gunnell Co-Director, WEPCT

Oksana Hoile Senior Manager

Phil Smith Lead RMG Manager

Lorna Gray Information Manager

Steve Davies Mental Health Lead (Exec Team), NEPFT

Andy Ritchie Secondary/Tertiary Care Representative (Exec Team), BTUFHT