The European Medicines Agency believes that the workshop it held last week on access to clinical-trial data and transparency has helped moved the process along.
The meeting, which was held in London and was moderated by Sir Mark Walport, director of the Wellcome Trust, was intended to elicit the views and concerns from a broad range of interested parties. These included representatives of the European Federation of Pharmaceutical Industries and Associations, the Cochrane Collaboration, which has spearheaded the high-profile campaign demanding that Roche finally publish the complete raw dataset on its antiviral Tamiflu (oseltamivir; see related link for more). Ben Goldacre, author of Bad Pharma, the book which has caused a stir among the sector for its criticisms of companies and regulators alike over their lack of transparency, also participated.
EMA executive director Guido Rasi said the 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". The EMA claimed the workshop marks the first step in the process, in line with a decision the agency made earlier this year, a move which "aims to build trust and confidence in the system by allowing re-analysis of clinical-trial data by stakeholders".
The agency added that it is "aware that there are practical issues and other considerations that need to be addressed and resolved" and its senior medical officer, Hans-Georg Eichler, noted that the EMA will establish policies "in close dialogue with its stakeholders in five different areas identified during the workshop". These are: protecting patient confidentiality; clinical-trial-data formats; rules of engagement; good analysis practice and legal aspects.
The EMA concluded by saying that "advisory groups with broad representation from all parties will be formed" and will start working on these topics in early 2013. Final advice from each group is expected by the end of April 2013 and the proactive publication of clinical-trial data is expected to come into force on January 1, 2014. Details about how to express interest in participating in these advisory groups will be published shortly on the agency’s website.
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