Dr David Jackson Clinical Lead for Research YCRN Co-director WYCLRN Yorkshire Palliative Medicine Regional Learning Group April 2008 Clinical Research

Dr David JacksonClinical Lead for Research YCRN

Co-director WYCLRN

Yorkshire Palliative Medicine Regional Learning GroupApril 2008

Clinical Research in Yorkshire:Infrastructure & management

Yorkshire Cancer Research Network

Background

• The NHS Cancer Plan 2000– NCRN 2001

• YCRN 2002

“Allow conduct of clinical trials and other well designed research, to enhance the quality, speed, co-ordination of clinical research and integration with cancer care”

• Best Research for Best Health 2006– UKCRN

• Comprehensive Local Research Networks

• The Cancer Reform Strategy 2007

Yorkshire Cancer Research Network

• Population 2.6M

• Yorkshire Cancer Network– service

• Acute Trusts– Cancer centre– Cancer Units

• Unit alliances

NCRN Portfolio“Clinical trials & other well designed studies”

– Elligibility• Funding

– NIHR, other government, non-commercial partners

» Open competition, peer review

» Clear value to the NHS

» Strategic direction for research

– Industry sponsored

– Overseas government

– Other high quality studies (e.g. EORTC)

• Formal adoption process

– Cancer• Prevention; screening

Trust Number of open studies

Airedale 15

Bradford 19

Calderdale & Huddersfield 27

Harrogate 20

Leeds 115

Mid-Yorkshire 24

York 20

YCRN Portfolio

YCRN Functions• National portfolio

• Approval processes– Local R&D– Ethics

• Training & education– GCP, communication

• Recruitment

• Follow-up

Core Team 7.6 WTE

Research Team9 WTE 1.1 WTE

1.9 WTE

0.9 WTE

2.3 WTE

1.6 WTE2.7 WTE

YCRN funded staff

• Budget– £730K

• YCRN staff– 26.6 WTE

• Non-YCRN– 59.8 WTE

YCRN funded staff• Non-surgical oncology

• Haematology

• Breast surgery

• Genetics

• Psycho-oncology

• Paediatrics

• Palliative care

Recruitment

2006/7 accrual of cancer patients by study type and by Trust

0

100

200

300

400

500

600

700

Aireda

le

Bradf

ord

Calde

rdale

/Hud

ders

field

Harro

gate

Leed

s

Mid

Yor

kshi

reYor

k

Hospic

es PCT

To

tal n

um

ber

of

can

cer

pat

ien

ts r

ecru

ited

Non-RCT

RCT

RecruitmentNetwork Annual Accrual of Cancer Patients

0

200

400

600

800

1000

1200

1400

1600

1800

2001/2 2002/3 2003/4 2004/5 2005/6 2006/7

To

tal n

um

ber

of

can

cer

pat

ien

ts

Not specif ied

Non-RCT

RCT

16.3% 13.8% 12.2%15.2%

– Vacancy control– Patchy portfolio coverage– Slow approval processes– Service support blocks

Strategic Plan• Strategic development of portfolio

• Network site-specific groups• Portfolio development officers• Specialist clinical advisors

– Hard-to-recruit areas• Streamline regulatory processes• Devolved teams across network

– Integrated within local teams• Developing & maintaining YCRN identity• Training & Education • Service User Partnership Group• Funding

• Commissioning• CLRN – service support costs

West Yorkshire Comprehensive Local 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

0

5

10

15

20

25

30

Jan/Feb

05Mar/Apr

05May/Jun

05Jul/Aug

05Sep/Oct

05Nov/Dec

05Jan/Feb

06

Participants Recruited

MHRN

Impact of MHRN Involvement on Study Accrual

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)

Impact of MHRN on Study Accrual

MHRN involvement in the project commenced in June 05.

First recruitment recovery plan 19 September 2005

Recruitment plan updated February 2006

NCRNAccrual to NCRN Portfolio studies

across the UK

The main aim of research networks: increasing recruitment into research studies


25 Comprehensive Local Research Networks CLRNs

N&EY & NL CLRN

WY CLRN


Aim of UKCRN• To provide the NHS infrastructure to support clinical

research across all areas of disease and clinical need• To help streamline the research management function for

UKCRN portfolio studies supported by the networks

To do this by: • Establishing a managed set of clinical research networks• Identifying a national portfolio of studies • Funding infrastructure (NHS support costs) for portfolio

studies• Supporting the research management of these studies


Research Funding• ARCO 2005

– Attributing revenue costs of externally-funded non-commercial research in the NHS

• Research costs» Data collection & analysis

» Research funding body (NIHR, Charity)

• NHS support costs» Additional tests, inpatient care

» nursing support, research professionals

» R&D support funding CLRN

• Treatment costs» Commissioning arrangements


Comprehensive Local Research Networks

• NIHR / UKCRN

• All healthcare – primary, secondary, tertiary, MH

– NHS service support costs• Infrastructure & running costs• Research staff• Research active clinicians

– Research Management & Governance• Streamline across network

– CSP / research passports

– UKCRN portfolio• Support for Topic Clinical Research Networks

– Cancer & Stroke• Primary Care Research Network


Replaces Culyer funding

Health Research CategoriesTOPIC TOPIC

Blood Cancer

Cardiovascular Dementias

Congenital Disorders Diabetes

Ear Medicines for Children

Eye Mental Health

Infection Stroke

Inflammatory and Immune Primary Care

Injuries and Accidents

Metabolic and Endocrine

Musculoskeletal

Neurological

Oral and Gastrointestinal

Renal and Urogenital

Reproductive Health and Childbirth

Respiratory

SkinWest Yorkshire Comprehensive Local Research Network

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


Resources• 08/09

• Core team £413K– Clinical directors, management team

• Per capita £2,250K• Activity based £1,424K• FSF

£112K

– Operational plan• Work in progress!

– Sessional payments– RM&G infrastructure– Research infrastructure– Service support costs– “Unblocking blocks”


Summary

• YCRN– Established & successful

• Need to maintain & increase recruitment

• WYCLRN– Rapid implementation & transition

• Streamlined RM&G• Transparent funding streams

– Strategic development of local portfolio» Strengths & weaknesses

– Unblocking blocks» Local knowledge

– Activity based funding

Documents

Dr David Jackson Clinical Lead for Research YCRN Co-director WYCLRN Yorkshire Palliative Medicine Regional Learning Group April 2008 Clinical Research