Tuesday 17 September, 2013
Professor Stan Kaye, Head of the Division of Clinical Studies at the Institute of Cancer Research (ICR) said:
“We are very supportive of wider registration and reporting of clinical trials, and would support legal requirements to publish data. However, the more pressing issue for us at ICR is the burden of EU regulation which is holding up clinical trials to find better cancer treatments*.
“We are pleased that this report acknowledges the significant problems facing research institutes involved in clinical trials and that ‘more can and should be done to make the UK a more attractive location for clinical trials’. This must be tackled at an EU level if we are to see worthwhile changes.
“The EU Clinical Trials Directive increased the regulatory burden on clinical trials, making them slower to set up and more expensive to run. Recently drafted revisions to replace the Directive do attempt to ease the regulatory burden in some respects, but don’t go far enough and aren’t clear enough.
“The main problem is a ‘one-size-fits-all’ approach to the regulation of clinical trials which does not distinguish sufficiently between the different levels of risk posed by commercial and academic trials. Nor does it draw enough distinction between trials testing novel drugs with an unknown safety profile, and those testing licensed drugs in a new setting.
“As the report quotes us as saying, the revisions make only a crude attempt at distinguishing between the different levels of risk and so fail to properly reshape the directive.”
*The Institute of Cancer Research, London is the leading academic cancer drug discovery unit in the world with the discovery and nomination for development of 20 drug candidates since 2005. The ICR-CTSU runs trials on different forms of cancer treatment, including chemotherapy, hormone therapy, radiotherapy, surgical treatments and combination. It has an expanding portfolio of exploratory phase II targeted treatment trials, trials in rarer tumour groups and trials in the surgical setting.