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Drug trial lawyer welcomes transparency move from EMA

The European Medicines Agency has opened up access to clinical data

Rotating test tubes

24 October 2016

Drug trial lawyer Gene Matthews has welcomed news from the European Medicines Agency (EMA) ] that is allowing open access to clinical reports to new medicines for human use authorised in the European Union.

The European Commissioner for Health and Food Safety said:

"Transparency is an essential component in clinical research. Its outcome – whether positive or negative – should be made publicly available. EMA's transparency initiative will make Europe a true front runner with respect to release of data concerning clinical trials. It will create a bridge from now until the new Clinical Trials Regulation - which foresees additional milestones towards transparency, becomes applicable."

The announcement is seen as an important one in marking a move towards greater transparency in clinical trials and medical science.

On 20 October the agency published some 100 clinical reports about two drugs, carfilzomib and lesinurad, which are EMA- approved medicines. Approximately 260,000 pages of information for more than 100 clinical reports will be added to the EMA’s online database.

Once the backlog of information has been added to the database the EMA intends to publish reports 60 days after a decision on an application has been taken, or within 150 days after the receipt of the withdrawal letter.

Access to some 4, 500 clinical reports should be available every year.

The clinical study reports produced by pharmaceutical companies who are testing new drugs provide much more detailed information about clinical trials than the papers published in scientific journals.

Clinical study reports include positive and negative results, as well as details about adverse side-effects reported during drug trials.

The information, available on the EMA clinical data website, will include the clinical reports contained in all initial marketing-authorisation applications submitted to the Agency on or after the policy's entry into force on 1 January 2015.

Clinical trials lawyer at Leigh Day Gene Matthews said:

“I welcome this move towards greater transparency in the publication of data received by the EMA from pharmaceutical companies who are carrying out clinical trials.

“Patients, trial participants and doctors have been lobbying for access to clinical trial data for many years and will welcome the greater transparency now available on all clinical trials, whether the outcomes are negative or positive.  I anticipate that it may take some time before the new system is fully functioning but it is a major step in the right direction.

“This move will build more trust in the regulatory system used across the European Union to monitor the safe development of new drugs for human use.  I hope that this approach is quickly adopted by other regulatory authorities around the world”.

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