ESC welcomes EC's revision of clinical trials

The European Society of Cardiology (ESC) has welcomed the European Commission's (EC) proposed revision of the full text of the European Clinical Trials Directive (EUCTD).

ESC has described the ruling as an important contribution to "simplifying, clarifying and streamlining rules for conducting trials throughout Europe.

The position paper has been coordinated by the ESC European Affairs Committee and calls for the role of reporting member states to be extended to cover "aspects of an intrinsic ethical or national/local nature".

Members of the ESC believe that greater representation of women, different age groups and ethnic minorities in trials would further enhance cardiovascular research across Europe.

Professor Frans Van de Werf, chairman of the ESC European Affairs Committee, is concerned by the adverse impact the 2001 EUCTD has had on non-industry trials.
These account for around 40 per cent of clinical trials in the EU.

"We firmly believe that to properly tackle CV disease (CVD), which is the number one killer in Europe, there's an urgent need to make it easier for scientists to undertake clinical studies and have come up with some additional suggestions to further simplify the research environment," professor Van de Werf said.

He went on to say that the implications of clinical research which go beyond science must be acknowledged.

"If it's made easier for academics to set up trials it should help us answer some really fundamental questions for people with CVD that aren't being addressed by Pharma.
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"We hope revisions will stem the decline in the number of investigator-led clinical trials that have occurred in the last few years and prevent patients from missing out on life saving advances."

The ESC particularly welcomed the development of a single EU portal to submit applications.

It believes such an approach would simplify the administrative work of academic researchers.