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Essex & Hertfordshire CLRN Demystified… Oksana Hoile Senior Manager

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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  1. Essex & Hertfordshire CLRN Demystified…Oksana HoileSenior Manager

  2. Clinical research: National Challenges

  3. "Problems cannot be solved at the same level of awareness that created them" Albert Enstein

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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…

  12. 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

  13. Which Trusts are in which Cluster?

  14. 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)

  15. 2009/10 Priorities

  16. 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’

  17. 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

  18. 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

  19. 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!

  20. Thank YOU for listening! Contact Details: Essex & Hertfordshire CLRNCS-09a, Primary Care Centre, Turner Rd, Colchester, Essex, CO4 5JR E-mail:clrn@neessexpct.nhs.uk Oksana.Hoile@neessexpct.nhs.uk 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

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