The UKCRN Portfolio

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The UKCRN Portfolio

• Jonathan Gower Assistant Director (CCRN)
• CCRN National Meeting
• London
• 16 January 2007

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The UKCRN Portfolio

• Why the Portfolio is key
• The benefits and challenges
• The Portfolio and whats on it
• What weve been doing to define the baseline
• Accessing the information and how to get a study
  onto the Portfolio
• What we are we doing/going to do
• What you need to do
• The process for new studies

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The Portfolio is at the heart of the UKCRNs
operations

• Resources are directed to where they are needed
• Planning, provision and access to infrastructure
• Collection of activity information and
  performance measurement

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How can the Portfolio help?

• A clear and up-to-date picture of what clinical
  research is being undertaken across the UK
• Replaces the NRR
• Provides information on studies that you might
  like to participate in
• Useful for putting together grant proposals
• Local and national strategic planning
• Funding is directed to demonstrably high quality
  research work
• Contains enough information on complexity and
  accrual data to support a dynamic allocation
  system funding and support directed to where it
  is needed incentives and growth
• Guaranteed support for NIHR Partner
  Organisation-funded studies no need to make
  choices anymore

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The Challenges

• Information just wasnt there
• Providing and collecting data is very mechanistic
• Infrastructure is often invisible
• Individual benefits are not immediately apparent
• Buy-in of all stakeholders is essential but has
  not been easy to achieve
• BUT
• Transition funding is disappearing
• Undertaking clinical research is not easy and we
  do need to unblock the blocks
• Is up-and-running in the Topic Networks

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Stroke Research Network Accrual
UK Accrual has doubled first 7 months 1017
2114 patients
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The UKCRN Portfolio

• A national register of all eligible studies
• NIHR portfolio in England eligibility defined
  by DH
• Portfolios in Northern Ireland, Scotland and
  Wales
• UK-wide working within portfolios
• Basic requirements funded in open national
  competition and with independent peer review
• Version 3 published in January 2008 now includes
• Research training awards
• Investigator-initiated commercial collaborative
  research
• Cancer studies agreed by CTAAC

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The need to interpret the eligibility criteria

• Confirmation of NIHR Partner Organisations
  (automatic eligibility), requires evidence that
  they
• Award research funds as a result of open national
  competition across England with high quality peer
  review
• Fund research that is of clear value to the NHS
• Take account of DH and NHS priorities and needs
  in their research funding strategies.
• Confirmed NIHR Partner Organisations
• NIHR Schemes
• Government Departments
• Research Councils
• Working through research charities
• Grey areas in terms of NHS involvement etc.

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What have we done to define the baseline CCRN
Portfolio?

• Migrated NRR data to the Portfolio database
• Collected data from NRR, CTUs, major funding
  bodies
• Chased (and chased) CTUs and individual CIs/study
  coordinators for information
• Set up a process for checking data and verifying
  information (QA)
• Worked with study coordinators to collect accrual
  data
• Made some improvements to the database
• Worked with Devolved Administrations to develop
  UK working
• Collected evidence on funders regarding NIHR
  Partner Organisation eligibility
• Inputted into the development of the IRAS database

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Network Recruitment
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NIHR CCRN Portfolio (accrual to confirmed
studies)
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How can you interact with the Portfolio database?

• Portfolio Database accessible through the UKCRN
  website
• www.ukcrn.org.uk
• Searchable by topic, study title/acronym, Chief
  Investigator/study coordinator
• Currently contains a lot of Potential CRN
  Studies migrated over from the NRR.
• Studies which are confirmed as being on the
  Portfolio are flagged as
• Funded by UKCRC Partner
• UKCRN-adopted, commercial study
• UKCRN-adopted, non-commercial study

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What needs to happen?

• Urgent need to get all current eligible studies
  onto the Portfolio
• Next 2 3 months is critical
• Accrual by CLRN ranges from 2 to 2219!!
• If its not on its not counted!

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Whats the process for getting a study onto the
Portfolio?

• Completion of the Initial Study Registration
  Proforma
• Contains the minimum dataset
• Available from website with notes for completion
• Adoption process through Topic/Primary Care
  Networks, or
• For CCRN, undergoes Quality Assurance check at
  UKCRN CC
• Record entered/updated on the Portfolio Database
• Letter of confirmation sent to CI/Study
  Coordinator
• Accrual collected from April 2007, then ongoing

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UKCRN CLINICAL STUDIES PORTFOLIO Initial Study
Registration Proforma For further explanation of
each of the data items listed below, please refer
to the accompanying document UKCRN Description
of Study Detail Data Items

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Once completed, please return this form by email
to portfolio_at_ukcrn.org.uk or by FAX to 0113 343
2300. Many thanks for your assistance. For
support in providing accrual information for this
study using the UKCRN Accrual Upload System,
please go to http//www.ukcrn.org.uk/index/librar
y/info_sys.html or contact the help desk on
07717 833310 Page 2 of 2

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What are we doing now?

• Continuing to work with DH to confirm NIHR
  Partner Organisations
• Continuing to collect data from confirmed NIHR
  Partner Organisations
• Working with Partner Organisations (through the
  UKCRC) to include supply of data as an condition
  of the award
• Receive and process completed Registration
  Proformas
• Work with study coordinators to collect accrual
  data
• Continue to make improvements to the database
• Continue to work with Devolved Administrations to
  ensure streamlined working across the UK
• Mapping accrual sites to CLRNs
• Producing regular reports

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What are we going to do?

• Develop adoption process for CCRN non-automatic
  studies (Specialty Groups to play a key role)
• Work through grey areas with DH and provide
  FAQs to underpin the Eligibility Criteria
• Send out monthly reports to CLRNs listing
  confirmed studies and accrual
• Receive and process completed Registration
  Proformas
• Work with accrual contacts to collect accrual
  data
• Make significant developments to the database
• Revamp website and make process as accessible and
  easy as possible
• Produce a range of communication materials

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What do you need to do?

• The responsibility for providing data in order to
  define the baseline CCRN Portfolio lies with the
  research community
• The CLRNs have an important role to play
• CLRNs to take a lead in ensuring that baseline
  data is collected but everyone needs to do their
  bit!
• Be patient while we confirm eligible funders and
  develop adoption processes
• Concentrate on the obviously eligible studies
  (let us worry about the grey areas)

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The process for new studies

• Portfolio registration will be integral to the
  NIHR Coordinated System for gaining NHS
  Permission (CSP)
• Minimum dataset derived from IRAS database and
  directly from funding bodies no need for CIs to
  supply this, no chasing up!
• Adoption processes will be up-and-running
• Access, searching and reporting from the database
  will be transformed
• Process for collecting accrual data is being
  reviewed

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• Jonathan Gower Assistant Director (CCRN)
• j.gower_at_ukcrn.org.uk
• 0113 343 0382
• www.ukcrn.org.uk