STAKEHOLDER LAUNCH

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• STAKEHOLDER LAUNCH
• 6TH JULY 2006

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• Support for research
• Chair
• Professor Chris Butler
• Associate Director
• CRC Cymru CC

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Infrastructure Support

• AWARD
• South East Wales Trials Unit
• Wales Cancer Trials Unit
• North Wales Trials Unit
• Welsh Health Economists Group
• Health Information Research Unit
• FORWARD RD management governance
• Equality and Diversity
• Language Awareness

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• STAKEHOLDER LAUNCH
• 6TH JULY 2006

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Launch of the Clinical Research Collaboration
Cymru Thursday 6th July 2006, Holland House
Hotel, Newport Road, Cardiff Dr Catherine A
Robinson catherine.robinson_at_awardresearch.org.uk
Phone/Ffôn 0845 601 8545 E-mail/E-bost
contact_at_awardresearch.org.uk www.awardresearch.
org.uk
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AWARD Management Group Catherine Robinson
Helen Snooks Michael Shepherd Ian
Russell Rhiannon Tudor Edwards David Ford
Gareth Williams Clare Wilkinson
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Roles

• Collaboration and partnership
• CRC Cymru Methodology Group
• Thematic Research Networks
• Research development
• research ideas
• peer reviewed national funding
• Commissioned work
• to inform the development of policy
• to evaluate policy implementation
• Training
• targeted post-graduate level

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Evolving Multi-disciplinary Foci

• other well designed studies
• Complex interventions
• Qualitative methods
• Process evaluation
• Participative methods
• well-being
• Broad determinants of health
• Quality of life
• Social Care
• Lifespan
• Interface between sectors

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• STAKEHOLDER LAUNCH
• 6TH JULY 2006

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• Trials Infrastructure
• Kerry Hood
• CRC Cymru Stakeholders Meeting
• 6th July 2006

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• North Wales Organisation for Randomised Trials in
  Health ( Social Care)
• Based in Institute for Medical and Social Care
  Research, University of Wales Bangor
• Part of the All Wales Alliance for Research and
  Development (AWARD)
• Led by Ian Russell

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• Based in Centre for Health Sciences Research,
  Cardiff University
• Led by Kerry Hood Mike Robling

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• Based with Wales Cancer Trials Network in
  Velindre NHS Trust funded by Cancer Research UK
• One of nine accredited cancer trials units in the
  UK
• Led by Tim Maughan Gareth Griffiths

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WHESS

• Collaboration between
• University of Glamorgan
• University of Wales Bangor
• University of Wales Swansea
• Health economics input into SEWTU N-WORTH, to
  thematic networks and other researchers
• Policy advice to Welsh Assembly Government, Local
  Authorities, NHS Trusts/LHBs and other public
  bodies

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Key points to note

• Trials Trials and other well designed
  studies
• Intentional absence of the term clinical

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• STAKEHOLDER LAUNCH
• 6TH JULY 2006

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Health Information Research Unit (HIRU)

• McKinsey Report identified cradle to grave
  electronic health record as major positive
  feature of UK - HIRU will contribute by
• Developing new methodologies
• For accessing and combining routine data in ways
  which do not breech data confidentiality rules
  and regulations
• Data mining of very large datasets (e.g.100m
  records) and geographical analyses
• Analysis of large volumes of narrative data using
  natural language processing
• Develop methods for data capture to common
  standards and definitions in multiple and remote
  locations.
• Exploring how to use routinely collected and
  other data to support research led by TRNs and
  research units.

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Health Information Research Unit applications

• Assessment of the feasibility of potential
  studies, and sample sizes of trials and cohort
  studies
• Support for study recruitment and long-term
  follow-up
• Evaluation of policy development, service
  planning and the implementation of directives and
  guidelines
• Monitoring of patient outcomes at a population
  level
• Monitoring of patterns of therapeutic
  intervention in clinical practice

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• STAKEHOLDER LAUNCH
• 6TH JULY 2006

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The Forum of NHS Wales for RD Management in
Health and Social Care

• Main aim of FORWARD To enhance the research
  environment
• Objectives
• Streamlining the processes for Research
  Governance and associated procedures to develop
  an integrated approach
• Building RD management skills and expanding the
  knowledge base to support those involved in RD
  management and improve overall quality
• Providing effective communication channels to
  raise the profile of RD and to facilitate
  research knowledge transfer

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The Forum of NHS Wales for RD Management in
Health and Social Care

• Main work areas
• Implementing the Research Passport system
• Unifying the review process
• Training/Education in Research Management
  Governance
• Promotion Dissemination
• Advice Line in RMG
• Policy Development Implementation

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• STAKEHOLDER LAUNCH
• 6TH JULY 2006

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• LLAIS WEDHS
• Dr Roiyah Saltus
• WEDHS Chair

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Gwasanaeth Cefnogi Isadeiledd Ymwybyddiaeth o
IaithLanguage Awareness Infrastructure Support
Service (LLAIS)

• Objectives
• To raise awareness of the implications of
  language choice for service users in relation to
  clinical, legislative and statutory requirements
• To advise TRNs to take account of the Welsh
  language and culture in the planning of research
  and development projects
• To offer guidance and support about enhancing
  Welsh language and cultural awareness at each
  stage of the research process
• To enable the integration of research findings
  related to the health and social care needs of
  Welsh speakers into mainstream policy

• Amcanion
• Codi ymwybyddiaeth o oblygiadau dewis iaith i
  ddefnyddwyr y gwasanaeth mewn perthynas â
  gofynion clinigol, deddfwriaethol a statudol.
• Cynghorir RhYTh i gymryd y Gymraeg ar
  diwylliant Cymreig i ystyriaeth wrth gynllunio
  projectau ymchwil a datblygiad
• Cynnig arweiniad a chefnogaeth sut i wellar
  ymwybyddiaeth or Gymraeg ar diwylliant Cymreig
  ar bob cam yn y broses ymchwil
• Ei gwneud yn bosibl integreiddio casgliadau
  ymchwil, syn ymwneud â iechyd a gofal
  cymdeithasol siaradwyr Cymraeg, i mewn ir polisi
  prif lif.

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Wales Equality and Diversity in Health and Social
Research and Support Group (WEDHS)

• To provide a gateway to all research in Wales
  specifically involving Black and Minority Ethnic
  (BME) patients, service users and community
  groups
• To establish a research support service that
  proactively and systematically promotes an
  equality agenda
• To design and support high quality evidence-based
  research strands with local, regional and
  All-Wales outputs that address the health and
  social care priorities of BME patients, service
  users, and groups in Wales
• To identify, review, and utilise existing and
  emerging research findings to define practical
  solutions to improve the health, social care and
  wellbeing of BME populations in Wales

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• STAKEHOLDER LAUNCH
• 6TH JULY 2006

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• Methodological Support for Research Excellence
• Ian Russell
• Institute for Medical Social Care Research, UWB
  
• on behalf of CRCC Methodological Network

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Clinical Research Collaboration Cymru (CRC Cymru)
WORD Strategic Advisory Board
UKCRC
Stakeholders Group
UKCRN
CRC Cymru Operational Steering Group
Cancer (WCTN)
AWARD
Management Executive
Mental Health (MHRN)
CRC Cymru Thematic Research Network Leads group
CRC Cymru Methodology Network
SE Wales Trials Unit (SEWTU)
Learning Disability Autism (LDAN)
Wales Cancer Trials Unit (WCTU)
CRC Cymru Coordinating Centre
Dementia ND (NEURODEM)
N Wales Trials Unit (N-WORTH)
Diabetes (DRN)
Research Governance FORWARD
Children
Health Economists (WHEG)
Research Professional Network
Training
Cynnwys Pobl / Involving People
Portfolio
Industry
Epilepsy (WERN)
Wales Equality Diversity (WEDHS)
Health Information Research Unit (HIRU)
Older People Aging (OPAN)
Welsh Language Awareness (LLAIS)
Public Health Improvement (PHIRN)
Involving People Advisory Group
Training Advisory Group
RPN Development Group
Thematic Research Network (TRN)
Emergency Unscheduled Care (TRUST)
Coordinating Centre Group
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Set up study
Thematic research networks
Research ideas
Collect data
AWARD
Methodological network
TGs
Research development group
Analyse data
Economists
RD managers
Infra structure
Publish
Involving patients
Research governance
Technical support
Disseminate
Research professional network
Implement
Grant proposals
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Generating ideas for research

• Potential sources
• Thematic Research Network
• Individual clinician / scientist who consults
  Research N / Methods N
• Existing Research Management Group
• Systematic review eg Cochrane Library
• Other research needs assessment eg NHS HTAP
• Early steps
• Assess feasibility with clinicians (eg TRN)
  researchers (eg TG)
• Consult Cynnwys Pobl specific patient / client
  group
• Consider other needs eg health economics

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Study protocol design

• Establish research development group ( 1 RN, 1
  RU)
• Include patient / client reps, WEDHS, Llais
• Systematic review of current evidence (eg AWARD)
• Adapt established methods to problem (eg MN
  directory?)
• Design simple, rigorous recruitment procedures
  (eg RPN)
• Select patient / client-centred outcomes (eg HIRU
  or TU)
• Calculate appropriate achievable sample size
  (eg MN)
• Outline statistical analysis plan (eg MN
  directory?)

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Research development

• Comply with MRC guidance on evaluation of complex
  interventions, cluster trials GCP
• Develop interventions their manuals / pathways
• Evaluate process alongside outcome eg CISHE
• Discuss RPN needs with CRCC portfolio group
• Choose funding body develop funding application
• Devise info sheets choose questionnaires
• Build team of centres, investigators
  contributors

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Specialist tasks

• Outcome measurement
• Select balanced, comprehensive portfolio (eg
  McDowell 96)
• Refine revalidate existing measures (Streiner
  03)
• Develop validate new measures as needed
  (Streiner 03)
• Health economic evaluation
• Design procedure to collect cost data (eg Netten
  annual)
• Select standard questionnaires develop needed
  others
• Plan estimation of resource use utility eg
  EQ-5D
• Plan estimation of cost-effectiveness under
  uncertainty

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Research governance

• Get approval from Medicines Healthcare
  Regulatory Agency if necessary
• Get RD approval in consultation with ForWaRD
• Secure sponsorship and ethical approval eg
  COREC
• Secure patient care costs from WORD and beyond
• Liaise with funders over finance reporting
• Initiate Research Steering Committee (RSC) eg
  MRC
• Initiate Data Monitoring Evaluation Committee
  (DMEC)

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Research implementation

• Choose between randomising via Internet (eg UWS)
• or via free telephone to clerical rota (eg
  N-WORTH)
• Develop implement data management plan
  including anonymisation, access archiving
• Design, program pilot Clinical Record Form
  patient questionnaires for scanning or electronic
  capture
• Manage surveys electronically including reminders
• Develop data base to manage assure all data
• Draft publication, dissemination implementation
  strategies

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Analysis

• Statistical principles govern most activities
  within study eg
• compliance with ConSORT
• developing and implementing statistical and
  economic analysis plans (eg Methodological
  Network directory?)
• reporting to RSC including monitoring recruitment
  (eg MRC)
• supporting DMEC including blinded interim
  analyses and stopping rules
• final analysis including planned subgroup
  analysis

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Developing CRCCMethodological Network

• Open to health social care researchers in Wales
• Committed to scientific rigour, practical
  relevance
• inter-disciplinary collaboration
• Will maintain directories of expertise studies
• (including protocols analysis plans?)
• Topic groups for design, development, process,
  outcomes, economics, governance, randomisation,
  data management, analysis, qualitative methods?
  systematic reviews? methodological research?

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• CRCC Methodological Network
• Ian Russell chair ian.russell_at_bangor.ac.uk
• Kerry Hood vice-chair hoodk1_at_cf.ac.uk

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• STAKEHOLDER LAUNCH
• 6TH JULY 2006

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• Transforming
• the Research Environment
• - the Challenge for CRC Cymru
• Professor Tim Maughan
• Director CRC Cymru
• Coordinating Centre

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Geographical Distribution of Combined Research
Funding in the UK
Wales 1.6
UKCRC review of RD, 2006
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How can we rise to the challenge?

• High quality ideas
• Collaborating to improve success rate in winning
  research funding
• R D approval system that facilitates rather
  than impedes research
• Support staff designed to deliver study
  initiation, accrual, data collection
• High quality research output and implementation
• A step change in research quality and activity

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CRC Cymru Co-ordinating Centre

• Research professional network
• Patient, service user and carer network
• Training
• Collaboration
• Industry

Lucy Branston lucy.branston_at_velindre-tr.wales.nhs.
uk Gill Coward gill.coward_at_velindre-tr.wales.nhs.
uk
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Research Professional Network

• The Plan
• To increase the number and skills of research
  support staff within primary, secondary and
  community sectors in Wales
• The Challenge
• To develop manage a team who can
• support a changing programme of work,
• covering a range of disciplines in health
  social care,
• where demand will be difficult to predict and
• capacity difficult to monitor

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RPN An evolving organisation

• Regional
• Unified across Wales but working locally in
  regions and groups
• Linking staff across care sectors seamlessly
• Unified
• Variety of staff and skills required for
  differing research methods
• Flexible to meet need but with specialist skills
• Communicating with people with impaired cognitive
  ability
• Mental health, dementia, learning disabilities,
  older people
• Those with a child-focus
• Children, epilepsy, diabetes, learning
  disabilities
• Primary care
• Majority of TRNs require support recruitment
  from Primary Care for some projects
• Nodal practices with 0.5 wte research nurse 3-5
  nodal practices in first wave

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Patient, service user and carer network

• Involving People
• Patient, Service User and Carer Involvement in
  Research
• Cynnwys Pobl
• Cynnwys Cleifion, Defnyddwyr Gwasanaeth a
  Gofalwyr mewn Ymchwil
• A network which engages constructively with the
  thematic research networks and the whole
  infrastructure

Prof Lesley Griffiths l.j.griffiths_at_swan.ac.uk Bry
an Collis, WCVA bcollis_at_wcva.org.uk Involving
people officer WCVA, Cardiff
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Training

• Training Needs Analysis
• Induction Programme
• Training programme complementing other providers
• To develop a highly skilled workforce
• Prof Joyce Kenkre jkenkre_at_glam.ac.uk
• Libby Batt libby.batt_at_velindre-tr.wales.nhs.uk

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Building the Collaboration

• To establish effective partnerships
• Within Wales Today onwards..
• Across the UK UKCRN
• With Industry Prof Keith Harding
• To develop an integrated whole system approach
• R D approval and funding FORWARD WORD
• Portfolio Group Prof Mike Owen
• To support organisational development
• Operational Steering Group TRN, ISS, CC
• TRN leads Prof Keith Lloyd
• Methodology Network Prof Ian Russell

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Clinical Research Collaboration Cymru (CRC Cymru)
WORD Contract management Strategic Advisory
Board
Cancer (WCTN)
Methodology network
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• The collaboration starts here!

www.crc-cymru.wales.nhs.uk
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• STAKEHOLDER LAUNCH
• 6TH JULY 2006