The European Medicines Agency is developing a policy on the proactive publication of clinical-trial data. From the beginning of this process, the Agency has taken a considered approach to developing a draft policy based on respecting the views and concerns brought forward by a broad range of stakeholders and European bodies.
The process started off with a workshop on clinical-trial data and transparency on 22 November 2012 to discuss the practical and policy issues that needed to be addressed before the Agency can begin to release these complex data sets.
The workshop gathered the views, interests and concerns of a range of institutions, groups and individuals with an interest in the issue, to help the Agency define how it should provide access to clinical-trial data in a manner that satisfies the needs of its stakeholders.
Following the event, the Agency issued a call for nominations to join advisory groups to inform it on five topics.
More than 200 people from all stakeholder groups applied to participate in one or more of the five advisory groups. 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?
Public consultation on draft policy
In June 2013, the Agency released the draft policy on publication and access to clinical-trial data for a three-month public consultation:
This consultation provided a further opportunity for stakeholders to send their comments. More than 150 individuals and organisations submitted over 1,000 comments. Healthcare professionals, academics and the pharmaceutical industry responded in broadly similar numbers and together represented almost half of all contributors. There was also significant input from patient organisations, regulatory authorities and health-technology assessment bodies and payers.
A large proportion of respondents were individual citizens expressing their support for the Agency's initiative to increase clinical-trial-data transparency.
The Agency is now considering all of the comments submitted in order to finalise the policy. The Agency expected to publish the final policy at the end of 2013, however, in order to conduct the appropriate in-depth analysis, the Agency will spend additional time in this reviewing phase, which may delay the finalisation. An update on timelines will be provided at the latest following the EMA Management Board meeting on 11-12 December 2013.
- Release of data from clinical trials
- Workshop on clinical-trial data and transparency (22/11/2012)
- Open clinical trial data for all? A view from regulators
- European Medicines Agency updates on development of its policy on publication and access to clinical-trial data (13/11/2013)