Today, the House of Commons Science and Technology Committee published the report of their recent inquiry into clinical trials
. The report acknowledges that there are problems with the current systems of regulation, and asks the Government to match their promises with effective action to make the UK a more attractive location for clinical trials.
I have been waiting with interest for this report to come out, as here at The Institute of Cancer Research, London, clinical trials are an important part of what we do. We run both early-stage clinical trials in the Drug Development Unit
(a joint unit of The Institute of Cancer Research (ICR) and The Royal Marsden NHS Foundation Trust) and later phase II and III trials in the Clinical Trials and Statistics Unit
Earlier this year the ICR submitted evidence for the inquiry
along with our partners at The Royal Marsden
, describing how the current regulatory system for clinical trials puts an enormous administrative and financial burden on academic clinical trials units, and has damaged the ability of academic organisations to collaborate internationally.
Across the EU, clinical trials of drugs are governed by the EU Clinical Trials Directive
, which was developed to protect the health and safety of clinical trial participants and to simplify and bring in line clinical trial administrative processes across the EU.
In practice, however, the Directive has been highly controversial, with many academic organisations, including the ICR
, warning that it has made the process of running trials more expensive and bureaucratic, with no obvious benefit on patient safety or the quality of trial data.
In particular, researchers at the ICR are concerned that regulation of clinical trials does not discriminate enough between the different levels of risk posed by academic and commercial trials. Many of the phase II and III trials run at the ICR test treatments that have already been licensed and have a well-established safety profile, but we are using them in a new setting. This is quite different from trials testing brand new drugs with unknown effects, and we think a new approach is needed to distinguish between the two. Earlier this year, ICR researcher Professor Judith Bliss commented on this in a piece in The Telegraph about the red tape that is holding up trials
, using the example of a well-established diabetes drug metformin which was being investigated in a cancer trial, but was still seen as high risk.
I was pleased to see this issue was picked up by the committee in their report, who said that: “We are not persuaded that proposals go far enough in ensuring that low-risk trials are regulated in a proportionate way. We urge the Government and MHRA to continue engaging at a European level to resolve these issues
A big focus of the report was on transparency around trial data, an issue which came to the fore with Ben Goldacre’s book Bad Pharma, and gained more momentum with the launch of the AllTrials campaign
in January 2013. In the report, the committee describe the current lack of trial transparency as “unacceptable” and call for the Government to enhance its efforts to increase transparency.
The ICR supports moves to ensure transparency in access to clinical trial data. We would like to see regulators monitor any discrepancy between the number of clinical trials which are registered and the number published, and recommend a legal requirement to publish clinical trial data within a certain timeframe.
Recently the Health Research Authority published plans
to make trial registration a condition of ethical approval, so steps are being made in this direction.
With the report advising that more needs to be done to support clinical trials in the UK and recommending that we need decisive steps to ensure greater transparency and better regulation, where do we go from here?
Last year in July 2012, the EU Commission proposed to replace the Clinical Trials Directive with an updated Clinical Trials Regulation
, to better standardise and streamline the process for authorising clinical trials.
The ICR has been working with other members of the medical research community to comment on drafts of the regulation as it passes through the legislative process - the AMRC blog featured a post on the latest joint briefing
if you are interested.
For the ICR and many others in the medical research community, we simply cannot afford to miss this opportunity to influence how trials are run. Delays and bureaucracy in clinical research translate into a longer waits to get new and improved cancer treatments to patients, so it’s really important to get the legislation right this time.
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