Document 6451751

Update on Paediatric Research under the
umbrella of the Medicines for Children
Research Network.
Dr Charlie Orton Ph.D
Local Research Network Manager
The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the
National Institute for Health Research and the UK Clinical Research Network
The origins of MCRN
• Part of the Infrastructure arm of Best
Research for Best Health (2006).
• NIHR CRN – tCRNs – LRNs – NHS
Organisations & Universities.
• National competitive bidding resulted in
Liverpool University being awarded with
the responsibility of hosting the MCRN
Co-ordinating centre.
• Subsequent national competitive
bidding then took place for NHS Trusts
to host local research networks – 6
LRNs resulted that cover 50% of the
paediatric population of England.
• Contracts were signed in April 2006
and immediate recruitment of staff
The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the
National Institute for Health Researchbegan.
and the UK Clinical Research Network
Professor Rosalind Smyth Director, Dr Vanessa Poustie Assistant
Director of the MCRN Co-ordinating Centre
1. Greater Manchester, Cumbria & Lancashire LRN – Dr
Peter Clayton Director, Dr Nick Webb Deputy
Director, Ms Sarah Rickard Manager.
Manchester Children’s NHS FT.
2. Cheshire, Merseyside & North Wales LRN – Dr Matthew
Peak & Dr Jo Blair Co-Directors, Dr Charlie Orton
Manager.
Alder Hey Childrens NHS FT
3. Trent LRN – Dr Alan Smyth Director, Mr Mark Howells
Manager.
Nottingham University Hospital Trust
4. West Midlands LRN – Dr Warren Leany Director, Dr
Sam Hayton Manager.
Birmingham Children’s NHS FT
5. SENCE (London SE, North Central & E) LRN – Dr
William van’t Hoff Director, Dr Nick Croft & Dr Shane
Tibby Co-Directors, Dr Paula Hurley & Sharon ? CoManagers.
Great Ormond Street
6. South West LRN – Professor Adam Finn Director, Dr
Andrew Collinson Co-Director, Dr Ruth Allen Manager
Bristol Royal Infirmary
The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the
National Institute for Health Research and the UK Clinical Research Network
“To facilitate the conduct of randomised clinical
trials and other well designed studies of
medicines for children, including those for
prevention, diagnosis and treatment”
The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the
National Institute for Health Research and the UK Clinical Research Network
Infrastructure of MCRN
Co-ordinating centre
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Clinical Study Groups, panels of experts in 14 specialties:
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Paediatric Clinical Trials Unit provides support on all aspects of trial
design and management:
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Develop and oversee the portfolio of studies
Propose and develop new studies
Consider studies proposed by others and advise on adoption into the portfolio
Provide specific expert advise to investigators
Ensure consumer involvement in all activities
Grant applications
Protocol and case report form development
Sponsorship
Legislative Frameworks
Regulatory Authority and Ethics Submissions
Design and analysis of trials
Data management and IT requirements
Preparation of reports for data monitoring and committees
The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the
National
Institute for Health
Study Adoptions
Committee
- Research
later and the UK Clinical Research Network
MCRN Work
streams
• Industry – Supported by a manager and liaison officer. Guide
companies through MCRN processes of adoption, send out
feasibility requests & provide reports on the commercial portfolio.
• PPI – Supported by a co-ordinator who has set up a consumer
group.
• Training & Education – Supported by a co-ordinator & a
steering group.
• Formulations – Supported by formulation scientists,
pharmacists and University Laboratories.
• Experimental Medicine – Supported by NIHR. Strategy
development to investigate new compounds.
The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the
National Institute for Health Research and the UK Clinical Research Network
Process – MCRN
adoption
• Study Adoptions Committee – must be applied to in order
to enter the portfolio and access LRN support. Whether commercial,
non-commercial or investigator led, the committee will consider
applications from sponsors who’s study meets all of the following
eligibility criteria:
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– Funded through open national competition by recognised/approved bodies
– Undergone scientific peer review
– Meet the remit of medicines for children
Once on the portfolio local research networks are approached to establish if resource
is available to support the study. Negotiative process utilising local knowledge.
Commercial studies are adopted on an ad hoc basis and often undergo rigorous
feasibility surveys prior to adoption during recruitment strategy development.
Non-commercial studies are adopted twice monthly when the committee meet via
teleconference.
SAC recommends investigators make contact with at least one of the support
mechanisms available prior to submitting for adoption and as early as possible in the
process of study development e.g. CSG, CTU.
The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the
National Institute for Health Research and the UK Clinical Research Network
Once adopted onto
the portfolio
• LRNs are given information about studies going forward
to adoption as early as possible.
• Sites may have already been chosen or additional sites
may need to be found.
• At an appropriate point contact is made between the
relevant LRN and the study team (CI, Co-ordinator,
CTU).
• Enter into a working partnership to identify support
needs, plan operational roll out of the study, set up the
study and ensure patients are given the opportunity to
enroll in a study in the best manner possible.
The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the
National Institute for Health Research and the UK Clinical Research Network
LRN support
• Anything and everything you can think of!
• LRN workforces consist of: Research nurses, research officers,
pharmacists, data managers, administrators and is led by individuals
who are highly experienced in the conduct of clinical research.
• Directly support principal investigators to achieve shorter set up
times, improved recruitment and compliance, understand regulatory
affairs, contracts and costings and liaise with service support
departments on their behalf.
The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the
National Institute for Health Research and the UK Clinical Research Network
MCRN current
portfolio
92 studies see separate excel spreadsheet…….
The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the
National Institute for Health Research and the UK Clinical Research Network
Performance
Measurement
• All LRNs and the co-ordinating centre are
performance managed by the DoH.
• MCRN performance measures are very similar
to all other research networks:
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Balanced portfolio
Set up times
Number of patients recruited to a clinical study
Number of studies recruiting to target and closing on
time
The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the
National Institute for Health Research and the UK Clinical Research Network
MCRN performance –
accrual.
Number of patients
MCRN cummulutive patient accrual to
date
10000
7765
8000
6000
4204
4000
2000
MCRN Accrual
363
0
2007 2008 2009
Linear (MCRN
Accrual)
Average
time to
achieving
100% target
accrual from
date site
activated =
253 days.
Snapshot 01/05/Year
The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the
National Institute for Health Research and the UK Clinical Research Network
MCRN Triennial
Review January 2009.
• MCRN classed as ‘outstanding’
• Awaiting final report
• Some recommendations:
– Expanding geographically
– Share best practice between the 6 LRNs
– Mapping of paediatric populations
Copies of the report submitted for the review are available
– please ask me for one!
The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the
National Institute for Health Research and the UK Clinical Research Network
For more information please go
to:
WWW.mcrn.org.uk
Thank you for listening!
The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the
National Institute for Health Research and the UK Clinical Research Network