The European Medicines Agency (EMA) has published the final advice from the advisory groups set up to inform the EMA in drafting its policy on proactive access to clinical-trial data.
In November 2012, the EMA organised a workshop to gather the views, interests and concerns of a range of institutions, groups and individuals with an interest in the topic. Following the event, the EMA issued a call for nominations to join advisory groups to inform the EMA on five specific aspects:
- Protecting patient confidentiality
- Clinical-trial-data formats
- Rules of engagement
- Good analysis practice
- Legal aspects
More than 200 people from all stakeholder groups applied to participate in one or more advisory group. The groups met between January and April 2013, with meetings taking place via teleconference.
The EMA will publish its draft policy at the end of June 2013, with a period of public consultation running until the end of September 2013. The final policy will be published at the end of November 2013. The EMA also confirmed its intention for the policy to come into force on 1 January 2014.