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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 hoile senior manager

Essex & Hertfordshire CLRN Demystified…Oksana HoileSenior Manager

Clinical research national challenges

Clinical research: National Challenges

Problems cannot be solved at the same level of awareness that created them

"Problems cannot be solved at the same level of awareness that created them"

Albert Enstein

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

    Which trusts are in which cluster

    Which Trusts are in which Cluster?

    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)

    2009 10 priorities

    2009/10 Priorities

    Essex hertfordshire clrn demystified oksana hoile senior manager

    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

    Essex hertfordshire clrn demystified oksana hoile senior manager

    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

    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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