The comments came as part of written evidence to the UK’s House of Commons on a proposed EU clinical trial regulation that aims to increase the number of trials by simplifying the rules for conducting them. The number of clinical trials conducted in the EU fell by 25 percent, and 22 percent in the UK, between 2007 and 2011.
The CCRA seems largely behind the new regulation, saying that a single regulatory approval portal “should help bring more trials to the EU and hence the UK.” A new definition of a low intervention trial and changes to safety reporting also should aid the approval of trials and reduce the burden on sponsors and CROs.
But the non-profit, government trade organization still believes a number of pending issues in the regulation will slow the growth of trials. For instance, the group says that research and development committees “continue to be a barrier,…need to be subject to statutory performance control,” and should “perhaps [be] integrated within the HRA [Health Research Authority].”
The European Commission also should “look at reducing the complexity of informed consent documents and data protection documents that put patients off [from] taking part for almost purely theoretical risks, reducing further cross border delays in trial logistics – critically with regions outside the EU and which allow greater integration of the routine, non-trial related health care that patients may need.”
Trial Insurance
A proposal in the regulation to require member states to set up a national indemnification mechanism that provides insurance for all clinical trials on a non-for-profit basis and gives sponsors the choice between private and Government-run insurance still needs some more consideration, the UK government and the CCRA say.
The UK “has never even implemented mandatory legislation to govern insurance of trials – unlike 22 other EU member states,” and the government should “be very concerned about being forced to implement the suggested National Indemnification Mechanism (NIM),” according to the CCRA.
The HRA and others have previously called for the support of new guidance on UK trial insurance to speed ethics committees’ approval of trials.
‘The Journal of Negative Clinical Trials’
Meanwhile, the CCRA is also pushing for the publication of all failed clinical trials in a journal “that is set up and run to the same level of scrutiny of any other scientific publication.”
“Peer review journals should take responsibility to ensuring negative clinical trials are published with the same priority as data which appears to push back the boundaries of science,” the CCRA says, noting that both pharma companies and academics fail to publish failed studies because of a lack of space to publish them.
“Alternatively, a fee could be levied on applications to carry out clinical studies in order to fund ‘The Journal of Negative Clinical Trials,’” the CCRA suggests.