UK Clinical Research Network (UKCRN)

UK Clinical Research Network

Maxine Stead PhD

UKCRN Assistant Director – Clinical Trials

UK Clinical Research Network (UKCRN)

Background

DoH announcement March 2004 : extra £100m p.a. by 2008 for research (in England) building on successful model for cancer research

Targeted research funding• Medicines for Children• Diabetes• Alzheimer's disease (now Dementias and Neurodegenerative Disease)• Stroke• Cancer• Mental Health

Clinical Research Network model(UKCRN)

UK Clinical Research Collaboration (UKCRC)

UK Clinical Research Network (UKCRN)

What is the UKCRC?

Partnership between government, the NHS, the voluntary sector, the private sector and the public

Aim is to transform the clinical research environment in the UK by: Taking strategic oversight of clinical research Identifying gaps in clinical research capability and opportunities for

action Developing coordinated approaches to addressing gaps/responding

to opportunities Monitoring progress in implementing plans and achieving objectives Providing leadership to develop the profile of clinical research and

enhance the research culture of the NHS

UK Clinical Research Network (UKCRN)

What is the UKCRN?

UKCRN will consist of a managed set of Clinical Research Networks to facilitate the conduct of randomised trials of interventions (including prevention, diagnosis, treatment, and care) and other well designed studies

Research projects funded by both commercial and non-commercial organisations will be incorporated

6 initial priority areas - cancer, mental health, medicines for children, diabetes, stroke and dementias and neurodegenerative disease

Future intention to extend UKCRN to cover full spectrum of disease and clinical need

Aim: to provide a world-class health service infrastructure to support clinical research and to make clinical research part of routine care

UK Clinical Research Network (UKCRN)

Organisational Structure of UKCRC/N

UK Clinical Research Network (UKCRN)

Role of UKCRN Coordinating Centre

National coordination of UKCRN activities Performance management of Topic-Specific Coordinating

Centres Financial management of UKCRN Links with UKCRC Development and provision of national systems and

approaches to trial development and management Conduit for addressing barriers to trials at a national level Central team of ~30-35 staff with leads for different

workstreams

UK Clinical Research Network (UKCRN)

Organisational Structure of UKCRC/N

UK Clinical Research Network (UKCRN)

Topic Specific Network Directors

Mental HealthDirector

Prof Til Wykes Cancer Director (acting) Prof Rick Kaplan

Medicines for ChildrenDirector

Prof Ros Smyth

DiabetesDirector

Prof Des Johnston

StrokeDirector

Prof Gary Ford

DenDRoNDirector

Prof Martin Rossor

UKCRN National CCCo- Directors

Prof Janet DarbyshireProf Peter Selby

UK Clinical Research Network (UKCRN)

Role of Topic-Specific Coordinating Centres

Portfolio development Management of Research Networks Performance management of Research Networks Provision of topic-specific training Coordination of consumer involvement Links with relevant trials units Main point of contact with UKCRN Coordinating Centre

UK Clinical Research Network (UKCRN)

Benefits of the UKCRN

Improved national coordination of clinical research Provision of national systems and advice structures

reduction in duplication of effort National coordinated approach to trial development

and trial portfolios Increased profile of research Improved trials benefits for patients

UK Clinical Research Network (UKCRN)

Development of research portfolios - National Clinical Studies Groups

Remit to develop a balanced portfolio of research studies that address uncertainties in patient care

Multi-disciplinary membership, transparent appointment Involvement of patients, carers and the public in:

prioritisation of questions development of study methodology and outcomes maintaining an overview of the portfolio and identifying gaps study overview and management dissemination of results

Links with funding bodies, NICE, James Lind Alliance Links with international groups to enable questions in rarer

conditions to be answered

UK Clinical Research Network (UKCRN)

CSGs in cancer Bladder Cancer Clinical Studies Group Brain Tumour Clinical Studies Group Breast Cancer Clinical Studies Group Colorectal Cancer Clinical Studies Group Complementary Therapies Clinical Studies Development Group Consumer Liaison Group Gynaecological Cancer Clinical Studies Group Haematological Oncology Clinical Studies Group Head and Neck Cancer Clinical Studies Group Lung Cancer Clinical Studies Group Lymphoma Clinical Studies Group Melanoma Clinical Studies Group Palliative Care Clinical Studies Development Group Primary Care Clinical Studies Development Group Prostate Cancer Clinical Studies Group Psychosocial Oncology Clinical Studies Development Group Renal Cancer Clinical Studies Group Radiotherapy Clinical Studies Group Sarcoma Clinical Studies Group Testis Cancer Clinical Studies Group Upper GI Cancer Clinical Studies Group

UK Clinical Research Network (UKCRN)

CSGs in cancer Bladder Cancer Clinical Studies Group Brain Tumour Clinical Studies Group Breast Cancer Clinical Studies Group Colorectal Cancer Clinical Studies Group Complementary Therapies Clinical Studies Development Group Consumer Liaison Group Gynaecological Cancer Clinical Studies Group Haematological Oncology Clinical Studies Group Head and Neck Cancer Clinical Studies Group Lung Cancer Clinical Studies Group Lymphoma Clinical Studies Group Melanoma Clinical Studies Group Palliative Care Clinical Studies Development Group Primary Care Clinical Studies Development Group Prostate Cancer Clinical Studies Group Psychosocial Oncology Clinical Studies Development Group Renal Cancer Clinical Studies Group Radiotherapy Clinical Studies Group Sarcoma Clinical Studies Group Testis Cancer Clinical Studies Group Upper GI Cancer Clinical Studies Group

UK Clinical Research Network (UKCRN)

LLCG-14Gem/ carbo ± thalidomide

Ming Lee/ Karen Owenllcg@ctc.ucl.ac.ukOpen nationally

GEM HospitalisationGem/ cisp vs Gem/ carbo

Nick Thatcher / Linda Ashcroftlinda.ashcroft@christie-

tr.nwest.nhs.ukLimited centre accrual

GRINRT vs RT + Gemcitabine

Allan Pr iceap@srv0.med.ed.ac.uk

Open nationally

SOCCARSequential vs Concur rent

CTRTJoe Maguire/ Car l J ackson

soccar@ctc.ucl.ac.ukDue to open soon

INCHCHART vs CT + CHART

Matthew Hatton/ Adrian Hodson

inch@ctu.mrc.ac.ukDue to open soon

Stage I/ III diseaseFit for radical chemo-radiotherapy, centre

able to do CHART?

Stage III diseaseFit for radical

chemo-radiotherapy?

Stage I/ II diseaseUnfit for surgery?

NCRI Lung Cancer Studies Group –Approved studies - Mar 04for more details see http://www.ncrn.org.uk/Portfolio

TOPICALBSC ± Tarceva

Ming Lee/ Blair Dickmantopical@ctc.ucl.ac.uk

Due to open soon

Fit for resection & chemotherapy?

LU22Surgery vs CT + Surgery

Ian Smith/ Adr ian Hodson lu22@ctu.mrc.ac.ukOpen nationally

Mesothelioma

Fit for radical resection?

MS01ASC vs ASC + navelbine vs ASC + MVP

Mar tin Muers/ Adr ian Hodsonms01@ctu.mrc.ac.uk

Open nationally

MARSCT/ RT vs CT/ surgery/ RT

Tom Treasure/Mark SydenhamMark.Sydenham@icr.ac.uk

Feasibility phase open soon

MesoVATSTalc pleurodesis vs VATS cytoreductive pleurectomy

Andy Ritchie/ Clare LarocheHelen.Munday@papworth.nhs.uk

Paula.Allen@papworth.nhs.ukLimited centre accrual

In development

BTOG 2 - carboplatin vs cisplatin 50 vs cispatin 80 - cindyb@trials.bham.ac.uk NOAH - 2x2 design - docetaxel vs gemcitabine / cisplatin vs carboplatin -p.j .woll@sheffi eld.ac.uk Brain metastases - steroids ± whole brain radiotherapy - paula.mulvenna@nuth.northy.nhs.uk SCLC - chemotherapy ± statins - m.seckl@imperial.ac.uk NSCLC - adjuvant chemotherapy vs neo-adjuvant chemotherapy - denis.talbot@cancer.org.uk Wedge resection - wedge resection vs radical radiotherapy -michael.snee@leedsth.nhs.uk Spinal cord compression - single dose vs multiple dose radiotherapy - peterhoskin@nhs.net Lung cancer - low molecular weight heparin - fergus.macbeth@velindre-tr.wales.nhs.uk

Epidemiology studies

Early Lung Cancer Study - molecular biomarkers in ear ly lung cancer detection - j.k.field@liv.ac.uk Liverpool Lung Project - j.k.field@liv.ac.ukGELCAPS - Genetic Lung Cancer Predisposition Study - t.eisen@icr.ac.uk MALCS - mesothelioma and lung cancer control study - j.peto@icr.ac.uk

LLCG-12Cisplatin + etoposide ± thalidomide

Ming Lee/ Karen Owenllcg@ctc.ucl.ac.ukOpen nationally

Fit for chemotherapy?

Small cell lung cancer

Non-small cell lung cancer

Yes

Yes

Advanced DiseaseFit for

chemotherapy?

Advanced DiseaseUnfit for

chemotherapy?

Yes

Yes

Yes

Requir ing treatment for pleural effusion?

Fit for chemotherapy?

YesYesYes

YesYes

Palliative treatmentRIB - Single dose RT vs Ibandronate for localised metastatic bone pain - Peter Hoskin/ Or la Cummins - orla.cummins@ctc.ucl.ac.uk

SC20 - Single vs multiple fractions for re-irradiation of painful bone metastases - Peter Hoskin/ Or la Cummins - orla.cummins@ctc.ucl .ac.uk

Yes

YesYes

YesYes

Flow chart by Richard Stephens - email: rs@ctu.mrc.ac.uk

UK Clinical Research Network (UKCRN)

Involvement of patients and the public

UKCRN Patient and Public Liaison Lead – Marianne Miles

Topic Research Network Leads Development of common standards and approaches to

involving consumers in UKCRN activities Membership of Clinical Studies Groups Establishment of Consumer Research Panels Provision of training and support

UKCRC – increasing public awareness of research

UK Clinical Research Network (UKCRN)

Summary

UKCRN will provide infrastructure to support clinical research that answers current uncertainties in healthcare

Links with James Lind Alliance important Development of Clinical Studies Groups provide

another forum to identify questions Links with patients and the public are fundamental Exciting times ahead!