New policy for release of clinical trial data
A stepwise approach
The European Medicines Agency (EMA) made a step forward towards more transparency of clinical trials data with a first draft policy emerging after their public consultation in 2013. EPF has consistently called for the publication of all clinical trial results, regardless of the outcome of the trial.
We have also supported the position that the Clinical Study Report (CSR) is not a commercially confidential document and should be made publicly available after the assessment is concluded. Regarding individual patient data (“raw data”), our response to the EMA consultation highlighted a number of concerns which would need to be addressed, such as informed consent, criteria for sharing data, and the structures that would be set up.
The Agency decided to follow a stepwise approach, given the complexities relating to sharing individual patient-level data. As a first step it will start publishing the CSRs submitted to the Agency in the context of applications for marketing authorisation. This is well in line with the new Clinical Trials Regulation (Regulation 536/2014), which states that the CSR data should in general not be considered commercially confidential once a marketing authorisation has been granted.
Stakeholders’ concerns addressed
EPF participated in a meeting with the Agency and other patient organisations on 6 May to discuss these proposals; a further debate took place during the PCWP/HCPWP meeting. In the meantime the Agency also received a large amount of correspondence from different stakeholders calling for a revision of the policy.
As a result, the Management Board on 12 June decided to revise the policy which we warmly welcomed. Users will after all be able to “download, save and print the data for academic and non-commercial research purposes”, instead of having access just in a view-only mode. We trust this will apply equally to patients and all members of the public who wish to access the data.
Adoption and next steps
The Agency will finalise its policy on the release of the CSR for adoption in mid-July and aims to start publishing them from 1 January 2015 at the latest. EMA will then tackle the issue of patient-level data in further consultation with relevant stakeholders.
We have previously suggested setting up a working group to define transparent and clear criteria for the release of such data (how to define informed consent, who can make these decisions in each case, protection of patient confidentiality, etc.) (Link). This group should include several patient organisation representatives to ensure that the criteria adopted are both fit for purpose, ethical, and acceptable to patients. EPF is committed to working together with the Agency to address these issues.
Contact: Kaisa Immonen-Charalambous, EPF Senior Policy Advisor, email@example.com
© Picture credits: Michael Chia, Creatifimage.be