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Academia and industry reinforce the challenge of the Clinical Trial Directive revision

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Academia and industry reinforce the challenge of the Clinical Trial Directive revision

The European Union’s Clinical Trials Directive has resulted in unnecessary complexity and bureaucracy. This burdens research with increased time and costs. 16 commercial and non-commercial organisations issued a joint statement outlining revisions that could help to streamline the approvals process.

The organisations want to see clearer and more proportionate rules for clinical trials that maintain quality and safety standards while reducing duplication, red tape and “a ‘one size fits all’ approach to trial regulation”. A revised version of the Clinical Trials Directive is expected to be published in mid-2012.

Full story and the full list of organisations can be found here:

http://www.pharmatimes.com/Article/11-09-27/Academia_and_industry_push_for_revisions_to_Clinical_Trials_Directive.aspx

related stories:

http://www.networks.nhs.uk/nhs-networks/pharmacy-and-clinical-research-network/news/nhs-conferderation-calls-urgent-need-to-address-clinical-trial-regulations