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 on Sunday 12. between 3-5pm.
This working group will focus in the first place to define de-identification standards in terms of rules to apply, rational and impact on data utility for quasi and direct identifiers in SDTM 3.2. A final draft will be sent for public review in Q1 2014.
A group was formed in July with representatives from Pharmaceuticals, CROs, Academia and Software companies that now consists of 3 subteams working on the different SDTM domains and variables:
Working Group Lead: Jean-Marc Ferran (Qualiance), PhUSE Strategic Partnerships Director
Special Purpose: Sarah Nolan (Liverpool University & Cochran) Gary Chen (Shire) Carl Herremans (MSD) Beate Hientzch (Accovion) Adel Salem (Novo Nordisk) Khaled El Emam (Privacy Analytics) Vinitha Arumugam & Patricia Coyle (GSK)
Events & Interventions: Kelly Mewes (Roche) Boris Grimm (Boehringer Ingelheim) Shafi Chowdury (Shafi Consultancy) Nancy Freidland (IBM) Cathal Gallagher (d-Wise) Anup Patel (GSK) Sarvesh Singh (ICON) Thijs van den Hoven (Astellas)
Findings Sherry Meeh (J&J) Lauren Shinaberry (BDLS) Kim Musgrave (Amgen) Gene Lightfoot (SAS) Per-Arne Stahl (AstraZeneca) Nate Freimark (Theorem) Jennifer Chin (EISAI) Kristin Kelly (Accenture) Joanna Koft (Biogen Idec) Jacques Lanoue (Novartis)
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