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. As part of this process, it released a draft policy on the publication and access to clinical-trial data in June 2013 for a three-month public consultation.
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 is committed to continously extending its approach to 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.
The Agency has embarked on this process because it believes that the release of data is about establishing trust and confidence in the system. 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 acknowledges that the publication of full sets of raw data runs the risk of breaching patient confidentiality and that analysis by independent groups is not always equivalent to it being free of conflicts of interests and of high quality.
Policy on publication and access to clinical-trial data
In June 2013, the Agency released a draft policy on publication and access to clinical-trial data for a three-month public consultation:
The Agency took a considered approach to developing this draft policy, based on respecting the views and concerns brought forward by a broad range of stakeholders and European bodies.
The draft policy balances the commitment to give the widest possible access to data for independent scrutiny with the need to protect personal data as well as legitimate commercially confidential information.
The Agency received more than 1,000 comments from an unprecedented range of stakeholders during the public consultation. The Agency continued to work with stakeholders, including industry, academia and civil society organisations, to further clarify and fine-tune the proposed rules to achieve the broadest possible consensus. This work was guided by a set of key principles agreed by the Agency’s Management Board on 12 December 2013. The policy was also discussed at the March 2014 Management Board meeting.
The Management Board meeting on 12 June 2014 agreed the policy on publication of clinical trial data, which will now be finalised with a view to its adoption by the Board through written procedure by mid-July 2014. For more information see European Medicines Agency agrees policy on publication of clinical trial data with more user-friendly amendments.
For more information on the development of the policy, see publication and access to clinical-trial data: an inclusive development process.
Summary results of clinical trials
The Agency is also involved in a separate process to make summaries of the results of clinical trials publicly available through the EU Clinical Trials Register.
In October 2013, the Agency upgraded the EudraCT database to enable sponsors to enter result-related information from clinical trials, in line with guidance from the European Commission. As of 21 July 2014, with the launch of a final iteration of EudraCT, all functionalities will be in place to enable the posting of results by sponsors in the EudraCT database on a systematic basis and it will become mandatory for them to do so. Based on this data, the summary results will be made publicly available in the EU Clinical Trials Register.
This is a separate initiative to the Agency’s goal of publishing clinical-trial data included in marketing-authorisation applications for medicines once the decision-making phase of the marketing-authorisation process has been completed.
- Clinical trials in human medicines
- Access to patient-level trial data – A boon to drug developers
- Open clinical trial data for all? A view from regulators
- European Medicines Agency agrees policy on publication of clinical trial data with more user-friendly amendments (12/06/2014)
- European Medicines Agency updates on development of its policy on publication and access to clinical-trial data (13/11/2013)
- Draft policy 70: Publication and access to clinical-trial data (24/06/2013)
- European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use) (30/11/2010)
- Heads of Medicines Agencies / European Medicines Agency guidance document on the identification of commercially confidential information and personal data within the structure of the marketing-authorisation application: Release of information after the granting of a marketing authorisation (27/03/2012)
- Principles to be applied for the implementation of the Heads of Medicines Agencies / European Medicines Agency guidance on the identification of commercially confidential information and protected personal data in marketing-authorisation applications (27/03/2012)