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The criticisms of Europe’s current clinical trials regime have been growing louder for years – and particularly from the academic community, who have felt disproportionately burdened by the provisions of the European Union’s 2001 clinical trials directive. Now some of those criticisms look as though they may be answered, in the proposal for new EU legislation that emerged in late July.
The draft regulation announced by EU health commissioner John Dalli last week makes offers many concessions to non-commercial researchers – notably with a much greater degree of flexibility, linked to an explicit recognition of the need for risk assessment. This is a direct response to the criticisms of the directive that it imposed obligations and restrictions irrespective of the level of risk to subject safety, ignoring the importance of variations in knowledge of and experience with the investigational medicinal product, and whether the intervention was a simple blood sample or a sophisticated biopsy.
So some of the obligations in respect of labelling, insurance, sponsorship and reporting are likely to be eased. And each EU country will be required to set up a mechanism to indemnify smaller low-risk trials that frequently encounter difficulties in obtaining insurance cover.
Françoise Meunier, the director general of the European Organisation for Research into Treatment of Cancer, was quick to see the potential advantages. “This sends an important message to academics, and is particularly encouraging for younger researchers”, she told ACT. “It is positive news for patients”.
Ingrid Klingmann, the chairperson of European Forum for Good Clinical Practice, also sees merit in the proposals, and again with a focus on non-commercial research. New proposals to allow co-sponsorship are “very good for academic trials”, she said. The envisaged special provisions for low- intervention trials (“really the niche of non-commercial academics”) could also be a big opportunity, she added. And the indemnisation plans are “really really good news”.
But a proposal is a long way from a new law, and for an area as complex as clinical trials, there are inevitably as many questions as answers. Meunier admits to being intrigued at how ethics committees would fit into the new picture: “This is really the missing part”, she says. She also wants to see more about how the definition of low-intervention trials will play into the eventual legislation.
Similarly, Klingmann’s enthusiasm for much of the boldness of the proposals is tempered by curiosity over how the European and national levels will be integrated, and how scientific questions will be married up effectively with ethical questions, or over what will result from the rather vague wording over use of languages.
Their views, and the views of many other thought-leaders in clinical trials, will resonate across Europe over the coming months as the discussions of Dalli’s proposal get underway in the EU’s legislative machinery. In this context, it is a sobering thought that there was enthusiasm for the EU’s first attempts to bring some order to regulation of good clinical practice as long ago as 1989 – and more than 20 years later, the efforts to provide a satisfactory framework in Europe are still far from completed!