Winter 2018

Journal Publication of Interest

Hopkins and colleagues September 2018 BMC paper Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability assesses if data sharing policies are facilitating independent researcher access to participant-level data from industry-sponsored trials 2 years after publication of the primary results.

EMA’s ‘Clinical data publication’ page

This page explains that EMA is temporarily suspending clinical data publication until further notice.

This page also includes links to:

• The "Support for industry on clinical data publication" page

  This comprehensive page includes detailed guidance for pharmaceutical companies on requirements to comply with Policy 0070, and also includes downloadable justification table templates

• EMA's clinical data website

  This page hosts publicly disclosed clinical data

• The "External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use" page

  The latest implementation guidance is Revision 4 dated 09 November 2018; read the summary of changes.

Data Sharing Conference, Brussels February 2019

On 12^th and 13^th February 2019, the ECCRT Data Transparency Conference will take place in Brussels. The programme on "Demystifying Clinical Data Transparency: Lessons learnt so far" includes speakers from the CORE Reference development team. Registration is now open.