Publication of clinical data

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The European Medicines Agency (EMA) bases its scientific opinions on the results of clinical trials carried out and submitted by pharmaceutical companies. On 1 January 2015 a new EMA policy on publication of clinical data entered into force. Under this policy, the Agency proactively publishes the clinical reports submitted as part of marketing-authorisation applications for human medicines. Since 2010 the Agency has been releasing clinical-trial reports on request, under its access-to-documents policy.

Policy on publication of clinical 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.

In October 2014, the Agency published its final policy on publication of clinical data: 

The policy entered into force on 1 January 2015. It will apply to clinical reports contained in all marketing-authorisation applications submitted on or after this date. The reports will be released as soon as a decision on the application has been taken. The publication of the first reports is foreseen for mid-2016.

The adoption of the policy followed extensive consultations by EMA with patients, healthcare professionals, academia, industry and other European entities. For more information on the consultation exercise, see Publication and access to clinical-trial data: an inclusive development process.

Implementation of the policy

To help stakeholders understand the requirements and prepare for the publication of clinical reports, EMA has organised a series of discussions and consultations on the forseeable work processes.

These focus on two sets of guidance under development, concerning:

  • identification and redaction of commercially confidential information in clinical reports submitted to the EMA for publication;
  • anonymisation of clinical reports.

To date, the following stakeholder meetings have taken place:

Agendas, meeting reports, presentations, question-and-answer documents and video recordings (when available) are provided on the meeting pages.

At its 7 September meeting EMA presented technical guidance on the procedural aspects related to the submission of clinical reports, including:

  • how material should be sent to EMA;
  • the workflow of the redaction consultation process;
  • the overall process leading to publication. 

EMA will consult with industry associations on the technical guidance.

EMA will also consult the European Ombudsman and the European Data Protection Supervisor. Following these meetings, the two guidance documents will be finalised for publication. Further updates to the documents are expected during the implementation of the policy.

Reactive release of documents

The new policy on publication of clinical data does not replace the existing EMA policy on access to documents, adopted in 2010. The access to documents policy enables third parties to request the release of documents held by the Agency, including documents submitted as part of marketing-authorisation applications. 

For more information, see:

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 making 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, it is mandatory for sponsors to post results on a systematic basis, and the summary results will be made publicly available. 

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