Rosalind L Smyth, Director MCRN NIHR Clinical Research Networks – what they mean for paediatrics.

Rosalind L Smyth, Director MCRN

NIHR Clinical Research Networks – what they mean for paediatrics

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 NetworkUK 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

0

100

200

300

400

500

600

700

800

0 1 2 3 4 5 6 7

Year

Num

ber

of p

atie

nts

Myeloma VII recruitment

Myeloma IX Recruitment(Younger patients)

Target

Comparison of recruitment into Myeloma VII (pre-NCRN) and Myeloma IX (post-NCRN)

National Cancer Research Network

(13.0%)

(10.5%)

(9.5%)

(5.5%)

(4.0%)

0

5000

10000

15000

20000

25000

30000

35000

40000

2001/02 2002/03 2003/04 2004/05 2005/06

UK

Acc

rual

Accrual to NCRN Portfolio studies Across the UK

FIRST PHASENCRN 2000~£20MMHRN 2003~£ 4M

SECOND PHASE (TCRN’s)

MCRN, DRN, SRN, DeENDroN 2005~£16M

THIRD PHASE Primary Care Research Network 2007~£ 2M

Comprehensive Research Network2007~£90M+

Introduction of Clinical Research Networks

Training & EducationSarah McCauleyDavid Edwards

Clinical Studies GroupsJennifer Blakeburn

Consumer InvolvementJenny Preston

Nicola Madge/NCB

Assistant DirectorVanessa Poustie

Rosalind SmythDirector

Administrative supportMoira Saphier

Kathy McKenna

Industry Liaison OfficerAndrew Rose

Tony Nunn

Portfolio ManagerTo be appointed

Neonatal Network CoordinatorSara Lewis

NPEU

Information SystemsChris Braithwaite

Clinical Trials UnitFour core staff

Paula Williamson

MCRN Co-ordinating Centre – Organogram and Workstreams

MCRN Local Research NetworksMCRN Local Research Networks

West Midlands

South West

Trent

SENCE

Greater Manchester,Lancashire &

S.Cumbria

Cheshire, Merseyside & North Wales

MCRN Local Research NetworksMCRN Local Research NetworksFunding: each LRN, £500K per annumFunding: each LRN, £500K per annum

LRN Director

LRN Manager

Research staff1 Administrator

6-7 Research OfficersPharmacist

Other support staffFormulations Scientist (in 3 LRNs)

UKCRN MCRN Local ClinicalLeads

Infrastructure support funding

also includes service support costs in the NHS

MCRN Clinical Studies GroupsMCRN 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 StudiesMCRN 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 studiesMCRN Portfolio studies

MCRN Portfolio studiesMCRN 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 RecruitingBlood 13Cardiovascular 208Congenital Disorders 1Ear 0Eye 25Infection 47Inflammatory and Immune 34Injuries and Accidents 9Metabolic and Endocrine 15Musculoskeletal 67Neurological 81Oral and Gastrointestinal 50Renal and Urogenital 19Reproductive Health &Childbirth

60

Respiratory 47Skin 16Generic Health Relevance 99GRAND TOTAL 1124

25 CLRNs

Some havespecial interests and capability in

Respiratory Health(perhaps 10-12) Collaborating Network Group

on Respiratory Health (10-12 members)

Appointed Chair

CLRN Respiratory

Interest Group

Functions

INDUSTRY LINKS;

ADOPTION;

ADVICE;

FEASIBILITY.

STUDIESLead

PROPOSALS FOR SUPPORTING TOPICS WITHIN CCRN

an example for Respiratory Health

NHS INFRASTRUCTURE

Local

National

25 CLRNs

CSG

Short Term Ad Hoc Groups

CSG

Longer Term Standing Groups

Collaborating Network Group

(10-12 members)

Appointed Chair

Portfolio Development

FUNDERS PROVIDE PRIORITIES AND SUPPORT

Short Term Groups

PORTFOLIO GENERATIONIN ACADEMIC SECTOR

NHS INFRASTRUCTURE STUDIES

Figure 2

Local

National

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

Clinical DirectorExecutive Group

supported byNetwork Manager & core team

UKCRCBSG

DH

UKCRNCC

HostOrganisation

NETWORK BOARD FUNCTIONSChecks & balances

EquityLocal interests

UKCRNCC FUNCTIONSPerformance management

National consistency

HOST FUNCTIONSContract holderHost services

(e.g. Finance, HR)

CLRN Organisational Template

Constituent NHSOrganisations

NetworkBoard

NHS Research Infrastructuredistributed across CLRN