Exemplar Industry Project

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Exemplar Industry Project

• Cheshire and Wirral

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Reason for the project

• UK has dropped from 3rd to 25th in EEC with
  regard to attracting Pharma studies.
• Probable causes
• RMG process is slow, cumbersome and arbitrary
• Recruitment is often poor and sometimes non
  existent.
• Plan to demonstrate that the NHS can deliver at
  same cost as other EEC countries but more
  effectively

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The Project

• Set up time and accrual relating to 20 studies
  sent by NIHR from phara to NW
• CM, Manchester, Cumbria and Lancs
• Period 12 months

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Background

• CM CLRN, 6 TCRNs and PCRN
• 15 Specialty groups
• CLRN revenue 9.5 million
• CLRN Trusts 27 Including 8 PCTs
• 5 main research active trusts
• 3 mental health trusts
• Current portfolio is divided into 1012 study
  sites across 25 Trusts

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Mixed model

• Research nurses
• 70 clinical support officers
• Centralised generic CSO (2-4)
• A proportion devolved to TCRNs/PCRN
• Remainder (40) managed by CLRN senior nurse and
  PIs, advice given by SRG leads
• Employed by individual trusts with flexibility to
  move between trusts
• Approximately 1/3 rolled out
• Management data base
• RMG
• RMG placed in Trusts (25 CLRN funded posts)
• Comprehensive training program
• CSP performance monitored through traffic light
  system
• Access to NIHR portfolio accrual data (by site)

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Performance indicators.

• Feasibility 2 weeks
• Study costing negotiation time 2 weeks
• Sign-off of model Clinical Trial Agreement
  (mCTA) within CSP time lines
• CSP performance and Research Governance Trust
  approval 5days
• Governance letters, approval and up-load 21 days
• Study recruitment including risk and contingency
  planning in order to achieve recruitment targets.
  Target 98 of studies exceeding or recruiting ot
  agreed numbers.

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Strategy/process

• Gain CLRN board sign up
• Track current industry projects (non exemplar) to
  identify possible problems.
• Provide all 27 trusts with letter of
  collaboration
• Set up tracking systems
• Getting info out of CSP
• Monitoring RD time lines
• Monitoring weekly recruitment
• Education regarding industry costing template
• Identify best trusts and build direct
  relationships with trust Boards
• Focus on pathway naming people responsible for
  delivery of each phase of set up in 5 leading
  trusts and engaging with trust board.
• Increase detailed pathway work with other trusts.
• Build direct contacts with PIs through
  feasibility studies .
• Ensure that Trusts and PIs funding is
  transparent.
• Have clear understanding with TCRNs regarding
  responsibilities and collaboration
• Prime PCRN to identify potentially receptive
  practices (Utilising LES scheme).
• Identify additional recourses to deploy in case
  of road blocks (from contingency)

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Industry Study Feasibilities

• We have received up to date 21 feasibility
  requests
• 1 open,
• 6 awaiting start-up
• 4 awaiting adoption
• 3 still in feasibility
• 7 we are not participating in
• 1 Cardiovascular study open in Aintree and Royal
  Liverpool currently have 23/35 patients.
  Recruitment ends Nov 09. We are top recruiters
• Nine studies gone through feasibility
• All within two week period
• Of the 7 studies that CM are not participating
  in
• 3 had no interested parties due to inclusion
  criteria
• 1 was in a rare disease type not seen often in
  CM
• 2 studies that were cancelled by the Sponsor

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Metrics
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Metrics
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Metrics
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Opportunities and threats

• Opportunities
• Contribute towards Research profile of the NHS
• Develop examples of good practice that may have
  lessons for other CLRNs
• Refine and improve local systems, delivery and
  accrual.
• Demonstrate good industry opportunities for NW
• Enhance profile of the CLRN in CM
• Threats
• Reduction of emphasis on non industry adopted
  studies
• Necessity to introduce financial re-imbursement
  of CLRN from trusts
• Increased monitoring/meetings/time/expenditure

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Questions
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End slide
The Cheshire and Merseyside Comprehensive Local
Research Network is part of the National
Institute for Health Research and the UK Clinical
Research Network