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 for the medicines it has assessed.
Publication of clinical-trial data
The Agency is committed to continuously extending its approach to transparency. A key goal in this process is the 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 embarked on this process because it believes that the release of data is about establishing trust and confidence in the system, because it will allow the public to better understand the Agency’s decision-making.
In addition, academics and researchers will be able to re-assess data sets. The publication of clinical reports will also help to avoid duplication of clinical trials, foster innovation and encourage development of new medicines.
Policy on publication of clinical data
In October 2014, the Agency published its final policy on publication of clinical data:
- European Medicines Agency policy on publication of clinical data for medicinal products for human use
- Q&A on the European Medicines Agency policy on publication of clinical data for medicinal products for human use
This follows a detailed consultation process launched in June 2013 when the Agency released the draft policy for a three-month public consultation.
The Agency took a considered approach to developing the draft policy, based on respect for the views and concerns of a broad range of stakeholders and European bodies. The draft policy balanced 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. Following 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 was guided by a set of key principles agreed by the Agency’s Management Board on 12 December 2013.
The policy was discussed at the March 2014 Management Board meeting, which agreed that the Agency should continue 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 through targeted stakeholder consultations.
The Management Board meeting on 12 June 2014 agreed that the policy on publication of clinical data would be finalised with a view to its adoption by the Board through written procedure by mid-July 2014. Subsequently, the Management Board postponed the final discussion and adoption of the policy to the Management Board meeting on 2 October 2014.
For more information on the comments received in the consultation exercise, see Publication and access to clinical-trial data: an inclusive development process.
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.
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 are in place to enable the posting of results by sponsors in the EudraCT database on a systematic basis and it is mandatory for them to do so. Based on this data, the summary results will be made publicly available in the EU Clinical Trials Register.
- Publication of clinical reports (02/10/2014)
- 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)
- European Medicines Agency policy on publication of clinical data for medicinal products for human use (02/10/2014)
- 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)