Archive for the ‘European Science Foundation’ Category

EU — Improving Medical Treatment Requires a Risk-based Approach to the Regulation of Clinical Trials

February 3, 2012 Comments off
Source:  European Science Foundation
Current EU legislation represents a major hurdle to improving medical treatment due to the straight-jacket of EU legislation that the 2001 Clinical Trials Directive imposes, a group of leading European medical scientists charged today in a position paper1 issued in Brussels and Strasbourg.
The paper issued by the European Science Foundation (ESF) and its European Medical Research Councils (EMRC) welcomes the planned revision of the 2001 Clinical Trials Directive expected later this year, but urges the Commission to take the opportunity to introduce a series of improvements to the Directive. These improvements include streamlining procedures, introducing a risk-based approach to authorising clinical trials and crucially ensuring greater harmonisation in the implementation of EU rules at national level so that clinical trials can take place across national borders.
“Balancing these aims with the imperative of maintaining a high level of patient safety is the major challenge facing the revision,” said Professor Liselotte Højgaard, Chair of the EMRC.
Finding that balance, however, is the key to preserving Europe’s position as an innovative and competitive research area.

Proposal for a revision of the “Clinical Trials Directive” (2001/20/EC) and other recommendations to facilitate clinical trials (PDF)


Get every new post delivered to your Inbox.

Join 363 other followers