Release of data from clinical trials

The European Medicines Agency bases its scientific opinions on the results of clinical trials carried out and submitted by pharmaceutical companies. The Agency has been releasing clinical-trial reports on request as part of its access-to-documents policy since late 2010 and is now working towards its goal of publishing clinical-trial data proactively for the medicines it has assessed. However, a number of policy and practical issues need to be resolved before this goal becomes a reality.

The Agency is committed to continuing to extend its transparency. A key goal in this process is the proactive publication of clinical-trial data for medicines once the decision-making process on an application for a European Union (EU)-wide marketing authorisation is complete.

Although the Agency is willing to deliver on this goal, there are a number of practical and legal implications that it needs to address and resolve first. It is therefore engaging in dialogue with its stakeholders to make sure that their views and concerns are taken into account.

This page summarises the current status of the Agency's activities related to this project. The Agency keeps the page up to date as the project develops.

Reactive release of documents

The Agency has been releasing documents submitted as part of applications for marketing authorisation on request since November 2010, when it published its new policy on access to documents:

• European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use)

According to this policy, the Agency releases these documents, including clinical-trial reports, once the decision-making process for the medicine in question has been completed.

More information on the types of documents the Agency holds, whether they can be released and whether they have to be redacted to protect personal data or commercially confidential information is available in this document:

• Output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use

Between November 2010 and April 2013, the Agency released over 1.9 million pages of clinical-trial data in response to safety-related requests.

Proactive publication of data

The Agency has committed to the proactive publication of the data from clinical trials supporting the authorisation of medicines. This will enable the independent re-analysis of the evidence used by the Agency's committees to determine their benefits and risks and is expected to lead to public-health benefits.

As outlined in the article 'Open clinical trial data for all? A view from regulators', published in April 2012, the Agency does not consider these data to be commercially confidential. However, it remains concerned that the publication of full sets of raw data runs the risk of breaches of patient confidentiality and that analysis by independent groups is not always equivalent to it being free of conflicts of interest and of high quality.

These issues may be addressed by the development of:

• standards for the protection of personal data;
• standards for meta-analyses and other types of confirmatory study;
• rules of engagement for sharing raw data from clinical trials.

Workshop on clinical-trial data and transparency

To address the practical and policy issues that will need to be addressed before the Agency can begin to release these complex data sets, the Agency hosted a workshop on clinical-trial data and transparency on 22 November 2012.

The workshop gathered the views, interests and concerns of a range of institutions, groups and individuals with an interest in the issue, to help the Agency define how it should provide access to clinical-trial data in a manner that satisfies the needs of its stakeholders.

The Agency is developing a policy on the proactive publication of clinical-trial data, with the help of five advisory groups focusing five different areas identified during the workshop. These are:

• protecting patient confidentiality;
• clinical-trial-data formats;
• rules of engagement;
• good analysis practice;
• legal aspects.

For more information, see policy on proactive publication of clinical-trial data.

Final advice from each group has been published. The Agency is drafting a policy on proactive access to clinical trial data. It will be published at the end of June 2013 and open for public consultation until the end of September 2013. 

The final policy will be published at the end of November 2013.

The policy on proactive publication of clinical-trial data is expected to come into force on 1 January 2014.