Publication and access to clinical data: an inclusive development process

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The European Medicines Agency has developed a policy on the publication of clinical data for medicinal products for human use. The Agency took a considered approach to developing this policy based on respect for the views and concerns brought forward by a broad range of stakeholders and European bodies.

The process began 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.

The final advice from each group, as well as comments from the participants, is available under documents from advisory groups on clinical-trial data.

Public consultation

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. 

An overview of the outcome of the public consultation is available in the below document: 

Further details on the comments received are provided in the below documents. Comments are listed by the number assigned to each stakeholder. They are divided into five separate documents due to the large volume of comments received. 

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 reviewed and analysed the comments received during the public consultation. The work was guided by a set of key principles agreed by the Agency’s Management Board on 12 December 2013. These included:

  • 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 included 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’).

Targeted stakeholder consultation

The policy was discussed at the March 2014 Management Board meeting. It was agreed that the Agency should 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 through targeted stakeholder consultations.

Three meetings or teleconferences were held in May 2014 with:

  • patient / consumer organisations and healthcare professional organisations;
  • pharmaceutical industry associations, including small and medium sized enterprises;
  • representatives from academia, research bodies, and medical journals.

The stakeholder consultations aimed at providing an update on progress made since the end of the public consultation on the draft policy and clarifying specific aspects of the policy prior to finalisation of the policy. In particular, stakeholders were consulted on the principles set for possible redaction of the Clinical Study Reports (CSRs) to be published, and the technical measures to make the data available under the policy, including the Terms of Use.

The Management Board meeting on 12 June 2014 agreed that the policy on publication of clinical data would be finalised with a view to its adoption by the Board through written procedure by mid-July 2014. 

Subsequently the Management Board postponed the final discussion and adoption of the policy to the Management Board meeting on 2 October 2014.

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