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German doctors criticise EU clinical trial reform plans

Could compromise patient safety says German Medical Association

Doctors in Germany have raised concerns that plans to overhaul the system of clinical trials in the EU could compromise the safety of study participants.

The German Medical Association (BÄK) criticised that, within the European Commission's (EC) draft proposal, which aims to make clinical trials faster, easier and cheaper, there was no explicit requirement for an independent ethics committee, and has requested one be added.

“The contribution of ethics committees currently protect the study participants, the scientific quality and the public trust in clinical research,” said the Association.

In addition, under the BÄK's proposed updates to the EC's draft, a negative decision from the ethics committee would mean permission for a clinical trial was denied.

Further demands from the BÄK included the option for member states to conduct their own checks into clinical trials that have previously been initiated in another member state.

Criticism was also aimed at the proposal's guidelines for conducting clinical trials in children and people incapable of giving consent, with the BÄK claiming it undermined Germany's own higher standards of protection for these groups.

The EC's draft proposal comes 11 years after the introduction of the Clinical Trials Directive (CTD) in the EU, and aims to ensure the rules governing trials are harmonised across Europe in order to create a simpler, less bureaucratic environment for clinical trial research.

At the time of the proposal launch, John Dalli, European Commissioner for Health and Consumer Policy, addressed safety concerns, stating the draft "significantly facilitates the management of clinical trials, while maintaining the highest standards of patient safety and the robustness and reliability of trial data."

However, the concerns raised by the German doctors could mean the guidelines are updated, with German MPs set to examine the proposal this week.

28th September 2012

From: Research, Healthcare



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