The European Medicines Agency (EMA) recently conducted a workshop on clinical-trial data and transparency in London following the agency’s decision, made earlier this year, to proactively publish all data from clinical trials and enable interested parties to access to full data sets. Guido Rasi, executive director of the EMA, said as he kicked off the event, “The European Medicines Agency is committed to proactive publication of clinical-trial data, once the marketing-authorisation process has ended. We are not here to decide if we publish clinical-trial data, but how.”
Nevertheless, before moving forward with this process, there are several practical and political considerations that need to be addressed and resolved. The purpose of the workshop was to gather the views, interests and concerns from a broad range of institutions, groups and individuals to help the EMA define the modalities of proactive access to clinical-trial data in a way that best serves patients and public health.
Transparency is important for building trust and confidence, and the EMA is striving to achieve this by allowing stakeholders to access and reanalyse data from clinical trials. This workshop is a starting point and based on discussions that took place, the EMA will establish policies in close dialogue with its stakeholders in five areas, namely, protecting patient confidentiality; clinical-trial-data formats; rules of engagement; good analysis practice; and legal aspects.
Advisory boards, represented by various parties, will be formed and work on these five topics will commence early next year with final advice from each group anticipated by April 2013. In a press release, the EMA stated that the proactive publication of clinical-trial data is expected come into effect on 1 January 2014.