European Policy Research
Cancer Clinical Trials in the
UK
Clinical trials in oncology in the UK are supported by a number
of NCRI partners (www.ncri.org.uk),
although the majority are funded and / or approved by Cancer
Research UK (link) and the Medical Research Council (link).
First-in-Man trials are predominantly undertaken through Cancer
Research UK and National Translational Cancer Research Network
(NTRAC) key centres (www.ntrac.org.uk),
whilst non-pivotal (therapeutic) phase II/III clinical trials
are conducted through the National Cancer Research Network
(NCRN) (www.ncrn.org.uk).
Regulatory & Legislation
Following the publication of the 'Clinical Trials' Directive
(2001/20/EC) the UK's Competent Authority the Medicines and
Healthcare Products Regulatory Agency (MHRA), published a consultation
document and partial impact assessment for implementing this
Directive into national legislation. This consultation (MLX-287)
triggered a large number of responses from many organisations.
The following organisation's responses are in the public domain:
Cancer Research UK - www.cancerresearchuk.org
Medical Research Council - www.mrc.ac.uk
An assessment of all the responses to MLX-287 was carried
out by Flavell and Sullivan: The EU Clinical Trials Directive:
An Analysis of the Responses Made to the MHRA Consultation
Letter MLX 287 Lancet 2003: 362:1415 (www.thelancet.com)
Following the consultation on the UK's implementation of the
'Clinical Trials' Directive a joint Department of Health (government
ministry) and Medical Research Council project was set up with
key stakeholders such as Cancer Research UK and the MHRA to
review how the Directive could be implemented without damaging
academic, publicly-funded clinical trials. Various specific
project teams have been set up including:
- Sponsorship
- Initiation of a Clinical Trial (including close-down)
- Management and Monitoring
- Pharmacovigilance
- Trial Supplies and GMP
Details of these workstreams, including implementation documents
can be found at: www.ncchta.org
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