The EU Clinical Trials Directive has come under fire again as figures show the UK’s involvement in both global and European trials has “dropped dramatically” since it came into force.
The Directive was introduced in the UK in 2004 with the overarching aim of promoting good clinical practice across Europe, but according to the NHS Confederation evidence shows that since then the UK’s involvement in global clinical trials has slipped significantly.
In fact, it says figures show the number of global clinical trials with UK involvement plummeted from 6% in 2004 to 2% in 2008, while, in 2002, 46% of EU products in studies were being developed in the UK compared to just 24% in 2007.
Department of Health figures also echo these findings, showing that the number of mid-stage, late-stage and post-approval clinical trials being carried out in the UK slid from 728 in 2008 to 470 in 2009, which, the NHS Confederation notes, is the lowest level in the last 10 years.
The data paints a very different picture from what the government is trying to achieve in making clinical research a key vessel for promoting the UK’s strengths as a life sciences business destination and thereby driving economic growth.
Improve climate
Indeed, in its submission to the European Commission the NHS Confederation’s European Office says there is an “urgent need” to improve the clinical trials climate in the UK and boost NHS organisations participation, “in order to attract investment and jobs, and help provide patients with early access to new treatments”.
In line with this, the organisation has called for a more streamlined ‘one-stop-shop’ approach for organisations taking part in clinical trials, “with a faster approval process and fewer variations in the way guidelines are interpreted in different countries” to simplify requests to undertake trials.
“The rules as they stand are not clear enough,” said Elisabetta Zanon, Director of the NHS Confederation’s European Office. “They do not provide NHS organisations with enough clarity about what processes they do and do not need to follow when applying to participate in a clinical trial. As a result the UK’s involvement in the global development of new medicines and technologies has stalled”.
“Clinical trial regulations should always put the safety of patients and those participating in clinical trials first. But the bureaucracy needs to be proportionate to the risk of the trial. What we are calling for is a system that is easier to navigate and gets the balance right”, she stressed.
A recent report by the Academy of Medical Sciences revealed that it takes an average of 621 days in the UK from a decision to support studies through to the first patient entering a trial, compared to 30 to 60 days in Canada, highlighting the complexities of the current system.
Streamline regulation
But it seems this is something the government is keen to address, having announced plans for a new health research regulatory agency to streamline regulation and improve the cost effectiveness of clinical trials.
And crucially, it plans to introduce a 70-day benchmark for recruiting first patients into clinical trials amongst other targets that will be linked to National Institute for Health Research (NIHR) funding to providers of NHS services.
“The NIHR provides the NHS with the support and infrastructure it needs to conduct first-class research funded by the government and its partners alongside high quality patient care, education and training, ” a DH spokesperson told PharmaTimes UK News, and also noted that the government intends to invest over £4 billion into research over the next four years.
