REGULATORY PUBLIC DISCLOSURE (RPD) - January

Journal Publication of Interest

In NEJM (22 Nov 18), Boehringer Ingelheim (BI) and the University of Basel describe An Industry Experience with Data Sharing, with BI - as a member sponsor - in listing studies on ClinicalStudyDataRequest.com (CSDR) for data sharing.

EMA Temporarily Suspends Clinical Data Publication, and updates Policy 0070 Implementation Guidance

EMA’s ‘Clinical data publication’ page explains that EMA is temporarily suspending clinical data publication until further notice.

This page 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.

Will EMA Retrospectively Publish Clinical Data When the Suspension is Lifted?

Question from Sam Hamilton to EMA (29 Nov 18): “As of 01 Aug 2018, EMA has suspended all new activities related to the publication of clinical data. Can EMA confirm if submissions made between 02 Aug 2018 and the (future) date of the lifting of the suspension - will or will not be subject to retrospective publication?”

Response from EMA (10 Dec 18): “…EMA is ONLY processing applications adopted by CHMP up to the first quarter of 2017 and which were submitted to the Agency by 31 July 2018 (upon receipt of an Invitation letter). 

We cannot currently comment on how the process will be resumed and whether clinical data will be published retrospectively. EMA will contact concerned applicants/MAHs prior to the restart of clinical data publication, once its relocation to Amsterdam is completed. 

We appreciate any preparatory work done by companies regarding their upcoming CDP package submissions, however, and EMA is asking companies simply to pause any ongoing work until further notice.

EMA RSS Feeds

This is a list of EMA RSS feeds - subscribe to selected topics and general news items. Although there is no RSS feed specifically for clinical trial publication, EMA advise to subscribe to the RSS feed “News and press releases” to keep updated on clinical data publication.

Resources

1. EMA published a meeting report titled "Data anonymisation - a key enabler for clinical data sharing" on their 30 Nov to 01 Dec 18 joint workshop with the US-based Multi Regional Clinical Trials (MRCT) Centre covering:

• The global landscape for clinical data sharing
• The foundations of data anonymisation
• The mechanics of anonymisation - meeting the challenge of different data types
• Balancing access and data utility
• Future challenges for data anonymisation

2. TransCelerate Biopharma have released a clinical study report template. Read the 07 Dec 18 CORE Reference Press Release on this, which includes all relevant links.