EMA unveils plans to reform clinical trial data
Aims to launch system of proactive clinical trial data in 2014
The European Medicines Agency (EMA) has unveiled plans of how it will introduce a new proactive system of releasing and controlling clinical trial data within the European Union (EU).
Speaking at an EMA workshop, the agency’s senior medical officer Hans-Georg Eichler said active consultations with the pharmaceutical and health sectors would begin early in 2013.
These discussions will focus on protecting patient confidentiality; clinical trial data formats; rules of engagement; good analysis practice; and legal aspects. These issues will be explored by advisory groups, including pharma industry representation, with final advice being issued by these teams by the end of April. This work will be drawn together by EMA in the summer with the goal of launching a new system of proactive clinical-trial data publication on 1 January 2014.
‘While the work on proactive disclosure is ongoing, the agency’s approach to reactive disclosure of data remains unchanged,’ said EMA.
Since November 2010, the agency has released more than 1.5 million pages of clinical trial data in response to safety related requests.
Also speaking at the workshop, EMA executive director Guido Rasi said: ‘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.’
He said EMA’s decision in principle made in 2012 ‘aims to build trust and confidence in the system by allowing re-analysis of clinical trial data by stakeholders’.
EMA added that its officials are aware that ‘practical issues and other considerations…need to be…resolved’.