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Pharmacists back trial transparency in Europe

European Association of Hospital Pharmacist supports EMA’s plans to improve access to study results

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Pharmacists in Europe have backed plans to improve access to clinical trial results in order to allow independent analysis of drug data.

The European Association of Hospital Pharmacists, which represents pharmacist organisations from 34 countries in Europe, gave its support to the European Medicines Agency (EMA) policy proposal during a consultation period that ended at the end of last month.

The EAHP said that greater transparency was needed to offer opportunities for independent scrutiny of the methodology and results of trials.

Improved transparency would also prevent duplication of research and enhance patient safety by increasing knowledge about adverse events, said the EAHP.

“Hospital pharmacists right across Europe are involved on a daily basis in the management and conduct of clinical trials,” explained EAHP president Dr Roberto Frontini.

“We therefore have a direct interest in being able to access key fields of information about previously conducted trials in order to best direct our efforts in this area, and take the correct steps in relation to protecting patient safety and the patient interest.”

The EMA's proposed policy divides clinical data into three categories of access: commercially confidential information; open-access data that does not contain patients' personal information; and controlled-access data that may include personal data and will only be accessible after the requester fulfils certain requirements.

Depending on what category data fits under, individuals and organisations will have controlled access to trial information if they meet certain criteria.

Plans for greater transparency have been an increasing subject of interest for pharma in recent years, and have attracted criticism from the European Federation of Pharmaceutical Industries & Associations (EFPIA), concerned by the impact any change would have on commercial confidentiality.

However, there has been a growing push towards improved access to data from the wider healthcare industry led by AllTrials, supporters of which include GlaxoSmithKline and NICE.

According to the EMA, more than 150 individuals and organisations submitted over 1,000 comments during the consultation period for its policy proposals.

This included the expected organisations and authorities, as well as individual citizens.

The EMA said it will consider all comments as it prepares to finalise its policy, which is expected to come into force on January 1, 2014.

Article by
Thomas Meek

8th October 2013

From: Research, Regulatory



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