Innovation in Healthcare. Clinical Research Networks

Transcription

1 Innovation in Healthcare. Clinical Research Networks Professor Tim Maughan Director Wales Cancer Trials Network Velindre Hospital, Cardiff University, UK

2 EUROCARE-3 summary: cancer survival in Europe at the end of the 20th century. M. P. Coleman, and the EUROCARE Working Group. EUROCARE-3 summary: cancer survival in Europe at the end of the 20th century. Ann Oncol 14: v128-v149

3 Cancer outcomes in Britain no difference significantly worse oesophagus brain melanoma bone testicular lymphoma leukaemia hepatobiliary pancreas lung breast colorectal stomach cervix ovary prostate kidney

4 Unnecessary lives lost in Britain cancer total no. best euro cf euro pts outcome average lung 42,013 5,882 FRA 1,260 breast 34,604 5,883 SWI 3,460 colorectal 31,292 5,007 NED 1,878 prostate 15,654 3,992 SWI 1,331 stomach 11,413 1,883 AUS 1,312 ovary 5, SWE 179 kidney 4, FRA 509 cervix 4, ICE 0 totals 149,950 25,361 9,929 M. P. Coleman, and the EUROCARE Working Group. EUROCARE-3 summary: cancer survival in Europe at the end of the 20th century. Ann Oncol 14: v128-v149

5 NHS Cancer Plan 14 day wait Multi disciplinary team working Cancer Research

6 National Cancer Research Institute A new organisation for cancer research in the UK

7 NCRI mission statement The NCRI is a partnership working towards an integrated national strategy for cancer research. Identifies gaps in the cancer research portfolio in the UK and highlights new scientific opportunities Promotes joint initiatives to address research gaps and capitalises on opportunities Provides strategic oversight for clinical and translational research in cancer Develops centralised facilities and resources

8 Objectives of the National Cancer Research Network To provide the NHS infrastructure to support randomised prospective trials of cancer treatment and other well-designed studies, in order to:- Improve patient care Improve the coordination of research Improve the speed of research Maintain and enhance the quality of research Improve the integration of research Widen participation in research.

9 National Cancer Research Institute (NCRI) Board Sub-Group on Clinical and Translational research NCRN Operational Steering Group Clinical Trials Units Committee National Cancer Research Networks (41) NCRN Coordinating centre Trial Approval Process CTAAC NCRI Cancer Study Groups (26)

10 The NCRI partnership CHARITIES Association for International Cancer Research, Cancer Research UK, Ludwig Institute, Macmillan Cancer Relief, Marie Curie Cancer Care, Breakthrough Breast Cancer, Tenovus, Yorkshire Cancer Research, Leukaemia Research Fund, The Breast Cancer Campaign, Roy Castle Lung Cancer Foundation, Wellcome Trust GOVERNMENT Medical Research Council, Biotechnology & Biological Sciences Research Council, Department of Health, Scottish Executive, Welsh Assembly Government and Northern Ireland Chief Scientist Office INDUSTRY Association of the British Pharmaceutical Industry

11 Examples of current working National Prevention Research Institute (NPRI) Supportive and Palliative Care collaboratives Lung Cancer strategic planning group PET scanning Clinical Research Development Groups International links: EORTC / NCI

12 Developing a clinical research network The Wales Cancer Trials Network

13 The Health Service Needs evidence of what is best care Needs evidence of what is not better High dose chemotherapy in breast cancer Raltitrexed in colon cancer Vioxx Therefore, clinical trials are an essential component of the cancer service Large numbers of patient volunteers are needed

14 Evaluation of new treatments Phase I Phase II Phase III (5-15) (15-50) (100s 1000s) Toxicity Efficacy Survival Quality of life Health economics

15 A Cancer Trials Network for Wales Network funded in 1998 to: Increase participation in research to 10% of new cancer cases Provide direct support to researchers Develop research culture & profile in Wales Establish a network of active collaborators Train and manage support staff Cancer Research-UK and National Assembly for Wales funded in partnership 50:50

16 The Cancer Service in Wales Llandudno Rhyl Bangor North Wales Aberystwyth Wrexham Wales Population 2.9million 15,500 new cancers per annum English Cancer Networks Cancer Centre Cancer Unit 3 Cancer Networks SW Wales SE Wales Haverfordwest Carmarthen Merthyr Abergavenny Llanelli Pontypridd Swansea Newport Bridgend Cardiff Hong Kong Population 6.9 million Cancer mortality 11,400 in 2001

17 Cancer Trials Patients 2.8% in Trials 150K pa 5.3 posts

18 Cancer Trials N Wales 25% 3 Cancer Research Networks, 40 staff 1.2m pa Per capita funding = England s SW Wales 26% Co-ordinating Office 228K SE Wales 49%

19 Recruitment vs. 10% Target % of new patients 1560 WCTN Set Up NCRN Set Up 1670 (10.6%) 1637 (10.4%) EU Directive 0 97/98 98/99 99/00 00/ / / / / / /07

20 NCRN Accrual (all/rcts) National Accrual as % of Incidence Nonrandomised Randomised 0 National Baseline 2001/ / / /05* *figures for 2004/05 are projections based on 8 months data

21 Accrual by Network Projected 12 month accrual as a % of incidence for 2006/7 by networks South West London West Anglia Peninsula Avon,Somerset,Wiltshire Mid Trent Central South Coast Arden Humber and Yorkshire Northern North East London Dorset Kent Derby/Burton Yorks hire South East London Greater Manchester North Trent South Essex Mid Anglia Leicestershire, Norfolk and Waveney Pan Birmingham Lancashire & South Cumbria Thames Valley Greater Midlands Three Counties Merseyside & Cheshire West London North London CCA Teeside, S Durham & N Sussex Mount Vernon Surrey RCT accrual overall accrual % of incidence

22 Accrual by tumour type * Brain Breast CCLG Colorectal Complementary Therapies Consumer Gynaecological Haematological Head & Neck Lung Lymphoma Melanoma Palliative Care Primary Care Prostate Psychosocial Radiotherapy Renal Sarcoma Testis Upper GI Bladder All groups total accrual (UK)

23 What are the benefits of the NCRN? 1. Trials are completed more quickly Stage 2 colorectal cancer 2. More ambitious trials are designed Metastatic colorectal cancer; rectal cancer 3. Improved links with industry COIN, Piccolo, 4. Increased breadth of issues addressed Prevention, early diagnosis

24 MRC COIN Phase III Trial First line metastatic CRC EGFR untested 2421 patients RANDOMIZATION ARM A CONTINUOUS CHEMO Oxaliplatin + FP* chemotherapy continued until progression, cumulative toxicity or patient choice ARM B CONTINUOUS CHEMO Ox + FP* + CETUXIMAB chemotherapy continued until progression, cumulative toxicity or patient choice ARM C INTERMITTENT CHEMO Oxaliplatin + FP* chemotherapy Treat for 12 weeks then stop Restart on progression for a further 12 weeks *Dealer s choice: Oxaliplatin Modified de Gramont or Oxaliplatin + Capecitabine

25 MRC COIN Trial Current Status 1409 patients entered in 2 years of accrual 95 active cancer centres across UK and Ireland Collaboration of funders Cancer Research UK Medical Research Council Merck KGaA Sanofi-Synthelabo NHS R&D

26 Cumulative Accrual /07 05/05 07/05 09/05 11/05 01/06 03/06 05/06 07/06 09/06 11/06 03/05

27 Genome wide DNA repair variance EGFR IHC, FISH, ras mutation World class integrated germline and tumour analysis aiming to identify determinants of response Pharmacogenomics of all agents Colorectal cdna microarray

28 Current Issues Not a problem Ideas Opportunity Funding Recruitment Consumer involvement Problems EU directive CTU capacity NHS environment R&D Approval and costings Overwork: follow up Balance of portfolio Rare cancers

29 NHS environment Stretched resources Radiology Pharmacy Day case facilities Radiotherapy waiting times Physics planning capacity Clinical research will always stretch the envelope, but is essential to provide evidence for best practice

30 United Kingdom Becomes the Cancer Clinical Trials Recruitment Capital of the World J. Natl. Cancer Inst : The more cancer patients that doctors recruit into clinical trials, the faster they can test new therapies. Yet recruitment remains abysmally low except within the United Kingdom. Last year 32,000 patients the equivalent of 14% of Britain's annual cancer incidence participated in cancer clinical trials. "That's the highest rate of cancer clinical trial participation of any country in the world," less than 3% of all U.S. cancer patients participate in clinical trials, NCI.

31 UK Clinical Research Collaboration BIG T Biosciences Innovation and Growth Team Academy of Medical Sciences NCRI success Research for Patient Benefit Working party UK CRC April 2004 budget statement

32 From cancer to medicine Dementia Diabetes Mental health Stroke Medicines for children A world class infrastructure for clinical research in the NHS

33 UKCRN National & Topic Specific Network Coordinating Centres UKCRN National CC Co- Directors Prof Janet Darbyshire Prof Peter Selby Mental Health Director Prof Til Wykes Cancer Director (acting) Prof Rick Kaplan Stroke Director Prof Gary Ford Medicines for Children Director Prof Ros Smyth Diabetes Director Prof Des Johnston Dementias & Neurodegenerative Diseases Director Prof Martin Rossor

34 UK CRC workstreams

35 Progress Established Coordinating centres and clinical research networks for topic Experimental medicine funding of 117 m from Welcome, CR-UK, MRC, Wolfson, British Heart foundation From establishing the Comprehensive Research Network to provide service support costs for research in all areas of medicine in the NHS

36 Clinical Research Collaboration Cymru (CRC Cymru) UKCRC Wales Office of Research and Development UKCRN AWARD SE Wales Trials Unit (SEWTU) Wales Cancer Trials Unit (WCTU) N Wales Trials Unit (N-WORTH) Methodology network CRC Cymru Operational Steering Group CRC Cymru Coordinating Centre Thematic Research Network Leads group Stakeholders Cancer (WCTN) Mental Health (MHRN) Learning Disability & Autism (LDAN) Dementia & ND (NEURODEM) Diabetes (DRN) Health Economists (WHESS) Health Information Research Unit (HIRU) Research Governance FORWARD Wales Equality & Diversity (WEDHS) Welsh Language Awareness (LLAIS) Research Professional Network Training Cynnwys Pobl / Involving People Portfolio Industry Thematic Research Networks Coordinating Centre IS Groups Children Epilepsy (WERN) Older People & Aging (OPAN) Public Health Improvement (PHIRN) Emergency & Unscheduled Care (TRUST) Methodology Groups

37 Conclusion Clinical research networks were initiated in Wales in Cancer from 1998 CRNs have become the dominant paradigm for supporting research in health and social care in the UK Have demonstrated outcomes in marked increase in research activity Require a whole system approach to address all the hurdles to clinical research to be effective

38 Conclusion The increase in quantity and quality of clinical research in the UK is delivering Faster trial results Earlier implementation of some research findings limited by cost A motivated and skilled workforce International attention Improved partnership with industry