History
Improving the quality of cancer care throughout the world is essential to
improve cancer survival rates. High quality research, to better understand the
disease process involved and to find more effective treatments, will make an
important contribution to this goal.
ClinOx has developed out of two organisations based in the Department of
Clinical Pharmacology at the University of Oxford: the National Translational
Cancer Research Network (NTRAC) and the Oncology Clinical Trials Office (OCTO).
NTRAC, led by Prof David Kerr, was funded by the UK government for a five year
period (2001-2006). Its aim was to meet the needs of industry by fast-tracking
high quality, cost effective early phase oncology clinical trials, through
centrally co-ordinated access, to a network of the UK’s leading cancer
researchers and comprehensive cancer centres. NTRAC was very successful and its
accomplishments included:
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The initiation of 10 early phase clinical trials which recruited approximately
300 patients from 12 UK centres in 24 months, involving novel signal
transduction inhibitors, spindle poisons, receptor tyrosine kinase inhibitors,
DNA repair blockers and innovative cytotoxic drugs;
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Negotiation of 31 trial site contracts on behalf of five global pharma
companies; and
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Site selection feasibility studies for a further 6 protocols.
The only gap in NTRAC’s armamentarium was that it was unable to provide
monitoring capacity, and thus sponsors had to provide this for each of their
trials. ClinOx has remedied this, and will provide full trial management and
monitoring capacity for their clients. In addition, while NTRAC only worked
with UK cancer centres, ClinOx will work with the best comprehensive cancer
centres around the world.
OCTO is a Phase III oncology clinical trials office that is directed by Prof
David Kerr, with Ms. Justine Smith as Trial Management Director. The aim of
OCTO is to run high-quality randomised controlled phase III trials looking at
effective cancer therapies, particularly in the field of gastrointestinal
cancer. To this end, it is currently running 4 large phase III studies and has
randomised 10,000 patients over the past decade. It has a staff of 30,
including clinical trial coordinators, clinical trial administrators, clinical
trial support officers, clinical trial monitors, a QA administrator and an IT
team. Consequently, OCTO can provide the following services: safety reviews,
randomisation service, data entry, database design and maintenance, QA, site
monitoring, trial management, drug supply monitoring and management, trial
funding advice and management, clinical research training, regulatory and EC
reporting and trial document design (including protocol writing).
ClinOx is built on the successes of NTRAC and OCTO. It has the necessary
expertise in trial design, negotiation & placement, acquired through
running NTRAC, and has access to all the necessary trial management, monitoring
and regulatory expertise through OCTO.