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 has reviewed and analysed the comments received during the consultation. The Agency will continue to work with stakeholders including industry, academia and civil society organisations, to further clarify and fine-tune the proposed rules to achieve the broadest possible consensus. This work will be guided by a set of key principles agreed by the Agency’s Management Board on 12 December 2013.
The key principles include:
- a stepwise approach for implementation with, as a first step, preparation for the publication of clinical study reports redacted as appropriate;
- development of a methodology for de-identification of patients;
- definition of a standard format for the submission of data.
The principles also foresee the introduction of preliminary steps prior to data access designed to address the risk of possible unfair commercial use of data, while ensuring proactive and non-selective access (‘use control’ not ‘access control’).
The policy was discussed at the March 2014 Management Board meeting. The Management Board meeting on 12 June 2014 agreed the policy on publication of clinical trial data, which will now be finalised with a view to its adoption by the Board through written procedure by mid-July 2014. For more information on the issues addressed at the June 2014 Management Board meeting see European Medicines Agency agrees policy on publication of clinical trial data with more user-friendly amendments.
- 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)