In 2013, the European Medical Agency (EMA) released a draft policy on the publication and access to de-identified clinical-trial data for a 3 month public consultation. A PhUSE working group provided consolidated industry comments on behalf of the PhUSE membership.
The EMA have now internally agreed the framework of the policy focusing on CSRs and the approach to raw-level patient data will continue to be discussed.
Ahead of this guidance and forthcoming EU law, many pharmaceutical companies have already started to prepare their own de-identified data to deal with research requests.
In 2014, 2 of the EU PhUSE Single Day Events have been focused around data transparency. It has become apparent during these 2 meetings that there is not an industry specific standard on what rules to use when de-identifying data.
Realising the impact that this will have on our industry and in line with the PhUSE strategy to act as the industry voice to regulatory agencies, the PhUSE Board recently agreed to set up a working group that will drive an industry set of de-identified rules that are based on the CDISC SDTM data model.
Collaboration on this is open to all PhUSE members, but we will limit each company to one person to control the size of the group and to ensure a wide industry view. There will also be a special session at this year's October conference in London.