The European Medicines Agency is developing a policy on the proactive publication of clinical-trial data.
On 22 November 2012, the Agency organised a workshop on clinical-trial data and transparency to gather the views, interests and concerns of a range of institutions, groups and individuals with an interest in the topic. Following the event, it issued a call for nominations to join advisory groups to inform the Agency on five specific aspects.
More than 200 people from all stakeholder groups applied to participate in one or more advisory group. The Agency accepted only one member from the same organisation in each advisory group. The groups met between January and April 2013, with meetings taking place via teleconference.
- Clinical-trial-advisory-group memberships
- Clinical-trial-advisory-group memberships per affiliation category
The final advice from each group, as well as comments from the participants, is available under documents from advisory groups on clinical-trial data.
The five advisory groups addressed the following topics:
|Protecting patient confidentiality||How can the Agency ensure through its policy that patient and other personal information will be adequately protected, i.e. that patients cannot be retroactively identified when clinical-trial data are released, and that applicable legislation, standards, and rules regarding personal data protection will be respected?|
|Clinical-trial-data formats||How can the Agency ensure through its policy that clinical-trial data can be shared, in the interests of public health, in a clear and understandable format that enables appropriate analyses and a swift implementation without undue burden to stakeholders?|
|Rules of engagement||Are there rules or conditions that should be in place before an external stakeholder can download clinical-trial data (e.g. formal acceptance of the need to respect personal data rules, uploading of analysis plans etc.)?|
|Good analysis practice||Are there good-analysis-practice guidelines that the Agency could ask external requestors of data to consider or be aware of, and that the Agency can apply when confronted with additional analyses from external parties?|
Are there any legal aspects other than personal data protection that need to be addressed when drafting the Agency’s policy?
Are there exceptional circumstances under which data can be claimed to be commercially confidential?
The Agency is drafting a policy on proactive access to clinical-trial data. It will publish this draft policy at the end of June 2013 for public consultation until the end of September 2013.
The final policy will be published at the end of November 2013.
The Agency expects the policy on proactive publication of clinical-trial data to come into force on 1 January 2014.
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