Commission proposes clinical trial revamp

Revision of rules aims to reduce the amount of bureaucracy.

The European Commission today (17 June) proposed revising EU rules on clinical trials in a bid to cut red tape. The existing directive has been heavily criticised by researchers since its implementation in 2004 for the administrative burden it places on researchers. 

The Commission has acknowledged that the directive, which imposes authorisation requirements for testing medicines, has caused problems. Speaking at a pharmaceutical industry event in March, John Dalli, the European commissioner for health, said: “In many cases, the way this process has been designed in the directive hinders the conduct of pan-European research projects.”

He said that inconsistent application by member states was to blame. To address this problem, the Commission has proposed that the rules be changed to a regulation, which will not be subject to differing transposition in each member state. “This time we have to get it right,” Dalli said.

The clinical trials directive was intended to simplify the authorisation of trials, but many feel that it has led to higher costs and an increase in paperwork. Even small-scale clinical trials can be required to submit massive volumes of documentation. 

The Commission says that differing transposition in the member states has contributed to a 25% decrease in the number of clinical trials conducted between 2007 and 2011.

The new regulation will feature an authorisation procedure whereby only one application would be needed per clinical trial, though it would still be subject to approval by each relevant member state.

The Commission would also be able to conduct controls in member states to make sure the rules are being properly applied.

The regulation would also contain transparency provisions that would make clinical trial results public and make it easier to tell whether a clinical trial is still ongoing.

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