EMA to publish clinical trials data
May 3, 2013
THE European Medicines Agency
has committed to the “proactive
publication of data from clinical
trials,” as part of its ongoing push
to increase transparency.
The move follows a workshop
last Nov to gather feedback from a
range of stakeholders.
Following the workshop
participants were invited to join
consultation groups set up to
advise on five areas: protecting
patient confidentiality, clinical trial
data formats, rules of engagement,
good analysis practice, and legal
aspects of the move.
The final proposal is that trial
data supporting the authorisation
of medicines will be published
once the marketing authorisation
process has ended, and which
the EMA does not consider to be
commercially confidential.
“The release of data is ultimately
about establishing trust and
confidence in the system,” an
official statement said.
The next step is to draft a formal
policy which will be subject
to consultation, with the final
outcome expected to come into
force on 01 Jan 2014.
The above article was sent to subscribers in Pharmacy Daily's issue from 03 May 13To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 03 May 13