Oncology and Haematology Clinical Trials

1
Oncology and Haematology Clinical Trials

• Dr Anne Thomas
• Senior Lecturer in Medical Oncology
• University of Leicester

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Historical perspective

• 1996 Medical Oncology arrived in Leicester
• 1996 First Clinical Trials in oncology
• 1998-2001 Development of the Clinical Trials Unit
• All phases of studies, all sites
• Limited national studies
• 2000 first Phase I study
• 2001 Advent of NCRN

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2001
4
2004 Major Restructuring

• Accommodate the EU Clinical Trials Legislation
• The Medicines for Human Use (Clinical Trial)
  Regulations 2004, SI 1031
• Streamline the Trials Process
• Attract innovative early clinical studies
• Fully incorporate haematology studies

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2004 major restructuring
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• Success in NCRN
• predominantly phase III studies
• Genetic/observational studies
• CRO7 and ASPECT
• Success in CTU
• Predominantly early phase studies
• Novel clinical trial design

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PTK/ZK Induced Significant reduction in Tumor
Blood Flow in Metastatic Colorectal Cancer by
DCE-MRI
Reduction in tumor blood flow through liver
metastases secondary to colorectal cancer at day
2 is significantly correlated with improved early
clinical outcome
Thomas AL, et al. Semin Oncol. 20033032-38. Morg
an B, et al. J Clin Oncol. 2003213955-3964.
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CRUK involvement

• November 2005 Designated Phase I/II CRUK Clinical
  Trial Unit
• 2006 Launched Experimental Cancer Medicine Centre
  Initiative Collaboration DoH and CRUK
• Leicester one of 17 centres nationally
• Money for infrastructure
• Opportunities

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ECMC Centres

• Addenbrooke's Hospital, Cambridge
• Southampton
• Royal Marsden Hospital,
• Barts The London Hospital
• University College Hospital
• Birmingham
• King's College, London
• Belfast
• Oxford

• Cardiff
• St James's Hospital, Leeds
• Western General Hospital, Edinburgh
• Leicester
• Glasgow
• Manchester
• Imperial College, London
• Newcastle 

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Experimental Cancer Medicine Centres

• An international review panel awarded ECMC status
  to 17 centres based on their scientific and
  clinical excellence. CRUK and DoH provided 35
  million to support world-class translational
  research across the UK
• The initiative was developed under the umbrella
  of the National Cancer Research Institute (NCRI)
  The network builds on the successful work of the
  Departments of Health-funded National
  Translational Cancer Research Network (NTRAC).
• The funding covers clinical, laboratory and NHS
  infrastructure costs
• The funds underpin the translational work needed
  to develop new anti-cancer drugs and diagnostics
  from the laboratory into clinics and then to test
  them in early clinical trials.

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ECMC - Investment for Quality assurance

• ISO 9001 documentation for SOPs
• Patchy GLP compliance in labs
• Regular audits
• In house/ RD
• Company
• Regulatory
• National networking sharing best practice

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2007/8 streamlining
ECMC funded
Joint position with NCRN
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The future

• Integration of labs with CTU
• ISO 9001 role out
• More translational model work eg. Resveratrol,
  irinotecan toxicity
• Integration of CTU with NCRN
• More joint positions, retainment of staff
• Commercial studies through NCRN
• Access LNR CRN
• CRUK opportunity to be one of their CRUK
  Centres new initiative
• Infrastructure from lab to bedside
• Capital monies