Essex hertfordshire clrn demystified oksana hoile senior manager
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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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Essex & Hertfordshire CLRN Demystified… Oksana Hoile Senior Manager

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Essex & Hertfordshire CLRN Demystified…Oksana HoileSenior 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

  • 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?

  • 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?

    • 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?

    • 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?

    • 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)

    • 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)

    • 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?

    • 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?

    • 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


    Which Trusts are in which Cluster?


    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)


    2009/10 Priorities


    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

    • 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

    • 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!

    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 YoungClinical Director, WHHT

    Caroline GunnellCo-Director, WEPCT

    Oksana HoileSenior Manager

    Phil SmithLead RMG Manager

    Lorna GrayInformation Manager

    Steve DaviesMental Health Lead (Exec Team), NEPFT

    Andy RitchieSecondary/Tertiary Care Representative (Exec Team), BTUFHT


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