Transcript UKCRN - UK Wide working

NIHR Clinical Research Networks –
what they mean for paediatrics
Rosalind L Smyth, Director MCRN
Plan of talk
• UKCRN and the history.
• MCRN – brief update.
• Comprehensive Clinical Research
Network.
• Implications for organisation and support
of paediatric research.
RESEARCH FOR PATIENT
BENEFIT WORKING PARTY
FINAL REPORT
“For us, science and research constitute a
front-line service, as they too, reduce distress
and pain and save lives”.
(Dr John Reid, Secretary of State for Health, 22 March 2004)
UK Clinical Research Network
Comprehensive
Research
Networks
National Cancer
Research Network
• Established 2001
• Coordinating Centre
in Leeds
• 40 Local Research
Networks across the
UK
• Total population 60.2
million (100%
coverage)
• 474 studies in the
portfolio
National Cancer Research Network
Comparison of recruitment
into Myeloma
and Myeloma
IX (post-NCRN)
Comparison
of recruitmentVII
into(pre-NCRN)
Myeloma VII and Myeloma
IX
800
Myeloma VII recruitment
700
Myeloma IX Recruitment
(Younger patients)
Number of patients
600
Target
500
400
300
200
100
0
0
1
2
3
4
Year
5
6
7
National Cancer Research Network
Accrual to NCRN Portfolio studies Across the UK
40000
(13.0%)
35000
UK Accrual
30000
(10.5%)
(9.5%)
25000
20000
(5.5%)
15000
(4.0%)
10000
5000
0
2001/02
2002/03
2003/04
2004/05
2005/06
Introduction of Clinical Research Networks
FIRST PHASE
NCRN
MHRN
2000~£20M
2003~£ 4M
SECOND PHASE (TCRN’s)
MCRN, DRN, SRN, DeENDroN
THIRD PHASE
Primary Care Research Network
Comprehensive Research Network
2005~£16M
2007~£ 2M
2007~£90M+
Information Systems
Chris Braithwaite
Rosalind Smyth
Director
Clinical Trials Unit
Four core staff
Paula Williamson
Portfolio Manager
To be appointed
Training & Education
Sarah McCauley
David Edwards
Assistant Director
Vanessa Poustie
Clinical Studies Groups
Jennifer Blakeburn
Administrative support
Moira Saphier
Kathy McKenna
Industry Liaison Officer
Andrew Rose
Tony Nunn
Consumer Involvement
Jenny Preston
Nicola Madge/NCB
Neonatal Network Coordinator
Sara Lewis
NPEU
MCRN Co-ordinating Centre – Organogram and Workstreams
MCRN Local Research Networks
Cheshire, Merseyside
& North Wales
Greater Manchester,
Lancashire &
S.Cumbria
West Midlands
Trent
South West
SENCE
MCRN Local Research Networks
Funding: each LRN, £500K per annum
LRN Director
UKCRN
Local Clinical
Leads
MCRN
LRN Manager
Research staff
1 Administrator
6-7 Research Officers
Pharmacist
Other support staff
Formulations Scientist (in 3 LRNs)
Infrastructure
support funding
also includes
service support
costs in the NHS
MCRN Clinical Studies Groups
Allergy, Nephrology, Infection & Immunity
Dr Mike Sharland
Anaesthesia, Pain, Intensive Care, Cardiology (APICC) Dr Robert Tasker
Diabetes, Endocrinology & Metabolic Medicine
Prof David Dunger
Gastroenterology, Hepatology & Nutrition
Dr Stephen Murphy
General Paediatrics (including Dermatology)
Dr Colin Powell
Methodology
Prof Peter Brocklehurst
Neonatal
Prof David Field
Neurosciences
Dr William Whitehouse
Pharmacy & Pharmacology
Prof Ian Wong
Respiratory & Cystic Fibrosis
Prof Jonathan Grigg
Rheumatology (MCRN/arc)
Dr Michael Beresford
Children’s Cancer and Leukaemia Group (CCLG)
Dr Bruce Morland
What is the UKCRN Portfolio?
• A national register of all eligible studies
– DH have defined ‘eligible’ for England – NIHR portfolio
– Emphasis on national competitive funding and external
peer review
– Portfolios in Northern Ireland, Scotland and Wales
– Aim is UK-wide working within portfolios
• multi-centre and single centre
• commercial and non-commercial
Details of current portfolio available on UKCRN website
(www.ukcrn.org.uk) (in development)
MCRN Portfolio Studies
•
•
•
•
•
•
•
51 studies adopted into Network
40 Non-commercial
11 Commercial - 9 different companies
Studies at different stages
Many different therapeutic areas
UKCRN Portfolio Database
More studies in pipeline
MCRN Portfolio studies
MCRN Portfolio studies
Comprehensive Clinical Research
Network (CCRN)
• to provide the NHS infrastructure to support
clinical research-25 CLRNs
• streamline the research management
function--reduce bureaucracy where possible
• Inclusive of all healthcare
• From April 2009 will be the main route for
NHS service support for clinical research
What is a Comprehensive
Local Research Network?
•
•
•
•
•
•
•
Primary vehicle for NHS infrastructure (service support)
Primary, secondary and tertiary care and MH
Clinical Director and Network Manager and core team
Network Executive and Network Board
Host organisation
Research management for portfolio
A typical CLRN:
- NHS staff – management, sessions for
clinicians, nurses, data managers, secretarial.
- infrastructure in primary care.
- diagnostics and service costs.
- running costs.
CLRN- A balance between national
standards and consistency and local
ownership and control!
Geography-functional clinical research entities
Host Organisations
Clinical Directors
Network Boards
Network manager/Core Teams
NHS Infrastructure (money)
Done quickly and in parallel—for patients
and staff (April –October 2007)
Resources
Stage 1- Allocated to all networks asap
• Core team (5 posts) ~ 300k pa per CLRN)
£200k (07/08)
• Per capita allocation (~1.5M per 2M pop)
£750k (07/08)
– Research management and governance
– Research Infrastructure (includes sessions for clinicians)
• Does NOT include non-staff clinical support costs (eg radiology,
pharmacy and pathology)
• 2006/7 pro-rata allocation based on roll-out
• In addition to existing transition funding and TCRN funding
Stage 2 – from April 2008
• Activity based
• Increased operational staff
• Non-staff support costs
• Rising to £90M pa … any necessary increases thereafter
NIHR Portfolio for CRN (Provisional)
Topic
Blood
Cardiovascular
Congenital Disorders
Ear
Eye
Infection
Inflammatory and Immune
Injuries and Accidents
Metabolic and Endocrine
Musculoskeletal
Neurological
Oral and Gastrointestinal
Renal and Urogenital
Reproductive Health &
Childbirth
Respiratory
Skin
Generic Health Relevance
GRAND TOTAL
Recruiting
13
208
1
0
25
47
34
9
15
67
81
50
19
60
47
16
99
1124
PROPOSALS FOR SUPPORTING TOPICS WITHIN CCRN
NHS INFRASTRUCTURE
an example for Respiratory Health
STUDIES
Lead
CLRN
Respiratory
Interest
Group
25 CLRNs
Some have
special interests and capability in
Respiratory Health
(perhaps 10-12)
Collaborating Network Group
on Respiratory Health
Functions
(10-12 members)
Local
INDUSTRY
LINKS;
Appointed Chair
National
ADOPTION;
ADVICE;
FEASIBILITY.
Figure 2
STUDIES
NHS INFRASTRUCTURE
Collaborating Network Group
25 CLRNs
(10-12 members)
Local
National
Appointed Chair
PORTFOLIO GENERATION
IN ACADEMIC SECTOR
Portfolio
Development
FUNDERS PROVIDE
PRIORITIES AND
SUPPORT
CSG
CSG
Short Term Ad
Hoc Groups
Longer Term
Standing Groups
Short Term Groups
How will non-medicines paediatric research
(NMPR) be represented within CCRN?
• Currently NMPR is not recognised within UKCRC/UKCRN
topic lists.
• Concerns about this have been expressed locally and
nationally.
• UKCRN have asked MCRNCC if they wish to become
involved in the co-ordination of NMPR studies across
England.
• This has been discussed at the MRCN Executive and
Board who were unanimous in support of this proposal.
• MCRN will ensure that their core business continues to get
high priority, but can use the infrastructure and links
developed to support all paediatric research.
Proposal to Co-ordinate NMPR
• Currently under discussion between MCRN,
UKCRN and DH.
• Actively being discussed at local level, and with
national organisations: RCPCH, Children’s
Research Alliance, APA, BAPs etc.
• CLRN Directors will be involved in identifying
level of interest and strengths in their CLRN.
• Full discussion planned at a meeting in 2008, to
include CLRN representatives and all
stakeholders.
Conclusions
• Pace of change is very rapid.
• Huge opportunities – need to be recognised and
grasped.
• Broad support but an anxious research
management community.
• Could become the best whole system for clinical
research in the world.
• For paediatrics, we must build on achievements
and position ourselves well for the future.
• All help and advice gratefully received
CLRN Organisational Template
UKCRC
BSG
NETWORK BOARD FUNCTIONS
Checks & balances
Equity
Local interests
DH
UKCRNCC
UKCRNCC FUNCTIONS
Performance management
National consistency
Network
Board
Clinical Director
Executive Group
supported by
Network Manager & core team
Constituent NHS
Organisations
NHS Research Infrastructure
distributed across CLRN
HOST FUNCTIONS
Contract holder
Host services
(e.g. Finance, HR)
Host
Organisation