N' IRELAND CANCER CLINICAL TRIALS UNIT

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N. IRELAND CANCER CLINICAL TRIALS UNIT

• Richard Wilson
• Department of Oncology, BCH/QUB
• 5 November 2003

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NICCTU AIMS

• ? Promote quality patient care by clinical trial
  participation
• ? Co-ordinate and promote cancer clinical
  trial activity throughout N. Ireland
• ? Drive phase I and II development
• ? Integrate with QUB and UU basic science and
  translational research programmes
• ? Develop and train clinical research staff

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NICCTU PATIENT RECRUITMENT
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BELFAST CITY HOSPITAL CHEMOTHERAPY FACILITIES

• ? 18 bed in-patient unit
• ? New 4.8 million 40 place day unit on C
  Floor opened on 12 May 2003
• ? New Haematology/Oncology Pharmacy
• - licensed drug preparation facility- gene
  therapy capability
• ? 58 million Cancer Centre to open in January
  2006

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N. IRELAND CANCER CLINICAL TRIALS UNIT
Investigators Oncologists Surgeons Physicians
Clinical Nurses
Executive Committee
Research Nurses and Radiographer
Clinical Trials Pharmacists
Research Scientists
Data Managers
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NICCTU WORKLOAD OCTOBER 2003

• ? 51 open trials (28 oncology, 23 haematology)
• ? 14 to open (10 oncology, 4 haematology)
• ? 30 oncology trials closed with 455 patients on
  review
• ? Breast, ovary, lung, GI 90 of oncology
  trials
• ? Currently recruit 6 of patients referred into
  trials

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N. I CANCER CLINICAL TRIALS UNIT CURRENT PHASE I
TRIALS

• ? PARP - Temozolomide with PARP inhibitor (first
  in human CRUK study with Pfizer)
• ? 667-Coumate steroid sulphatase inhibitor in
  locally advanced/metastatic breast cancer (first
  in human CRUK study with Sterix)
• ? Scotroc 3 Taxotere/Carboplatin with Tarceva
  EGFR inhibitor in stage III/IV ovarian cancer
  (SGCTG with Aventis and Roche)
• ? Weekly Taxotere with 2-weekly Oxaliplatin
  (investigator initiated study with Sanofi)

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NICCTU WORKLOAD OCTOBER 2003

• ? 4 open phase I trials (one SGCTG, one
  investigator initiated, 2 CRUK) and several to
  open soon
• ? 8 open phase II trials, 2 to open
• ? 30 open phase III trials, 6 to open
• ? 4 open radiotherapy/combined modality trials
• ? 2 ovarian cancer screening studies, 1 PK study
  and 1 genetic abnormality study
• ? 1 PET-based study open, 2 in planning

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N. IRELAND CANCER CLINICAL TRIALS UNIT CURRENT
STAFFING

• ? Research Nurses 9.0 WTE (1 paediatric oncology
  and 1 palliative care nurse to be appointed)
  
• ? Research Therapy Radiographer 1.0 WTE
• ? Data Managers 4.0 WTE
• ? Data Clerk 1.0 WTE
• ? Research Assistants 2.0 WTE
• ? Clinical Academics 0.5 WTE
• ? Biostatistician/informatician 0.0 WTE (support
  from CRSC in RVH)

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THE ALL IRELAND COOPERATIVE GROUP FOR CANCER
CLINICAL TRIALS (AICG) AIMS

• ? To improve cancer care in Ireland through
  participation in clinical trials
• ? New approaches to
• Prevention
• Diagnosis
• Treatment

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ALL IRELAND COOPERATIVE GROUP for CANCER CLINICAL
TRIALS
This is the first cooperative group on the island
of Ireland, bringing together those involved in
cancer research and care in both Ireland and
Northern Ireland in a new organisational
arrangement. It is a major demonstration of the
impact of the Cancer Consortium to develop new
and dynamic ways of improving care for cancer
patients. The all-island cooperative group
offers an opportunity to develop clinical trial
activity to a much more sophisticated level, in
cooperation with colleagues in the US, the UK and
the rest of Europe.
Statistics Data Management Clinical Research
Support Centre

Clinicians Investigators Prevention Diagnosis Tr
eatment Surgery
Radiotherapy Chemotherapy Immunotherapy
Hormonal therapy etc.
Administrative Centre ICORG Office
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AICG STRUCTURES

• ? Clinical Centres
• ? Operations Office (ICORG)
• ? Statistical Data management Centre (CRSC)
• ? Committees
• ? Operational Framework
• ? Procedures

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AICG CURRENT STATUS

• ? Key appointments
• Group Chair
• Group Statistician
• ? Committees
• PI
• Executive
• ? Trials
• First AICG protocol initiated Sept 03
• First patient randomised Oct 03
• ? Collaboration
• Statistics for ICORG 97-01 Trial

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AICG KEY MILESTONES

• ? External Consultant
• ? Group statistician
• ? Statistical Data management functions at CRSC
• ? Development of procedures
• ? External Advisory Committee
• ? Research Plan
• ? Evidence of Trials
• ? Functioning committees

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AICG NEXT STEPS

• ? Awareness
• Communications
• ? Participation
• Committees
• Trials
• ? Ideas for New Trials
• What are the burning clinical questions?
• What is feasible?

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NICCTU NCRN LINK

• ? National Cancer Research Network in England
  (part of NCRI)
• ? 34 networks
• ? Links to Scotland, Wales and NI at various
  levels
• ? National portfolio of trials
• ? Trial accrual increased from 3.5 to 7.5 in 2
  years

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NICCTU NTRAC LINK

• ? National Translational Cancer Research Network
  (part of NCRI)
• ? 10 NTRAC centres established in England
• ? Opened to applications for one centre each in 3
  Celtic nations
• ? NI and Wales successful in summer 2003
• ? Funding locally from RD Office

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FUTURE OF NICCTU

• ? Clinical trials concentrated in BCH cancer
  centre but fully linked with 4 cancer units
• ? Increase in trial patient numbers - aim for
• 10 of all patients by 2005 (achieved 6 in
  2002)
• ? New focus on phase I and early phase II
  development
• ? Core funding required to facilitate
  development
• staff, accommodation, hardware, geographic
  coverage, other disciplines (eg surgery, imaging,
  nurses, AHPs)