Jean-Marc Ferran will be presenting on (1) differences and synergies on Data Sharing requirements across agencies and (2) data utility in anonymised CSRs:

EMA, Health Canada and FDA: Three Agencies Tackle Data Sharing. Synergies and Differences

Abstract: The EMA and then Health Canada have respectively launched separate data transparency policies around sharing of Clinical Study Reports (CSRs). The two regulators are providing additional guidance to help with implementation of their policies and have each formed stakeholders’ groups.

These two stakeholders’ groups include a variety of professionals and representatives across Life Sciences and focus on topics around data anonymisation, risk of re-identification and data utility while Health Canada’s Reference Group also addresses scope and process-related matters.

This presentation will explain the approaches, goals and achievements of these two stakeholders’ groups and reflect on the EMA and Health Canada’s Data Sharing processes and requirements and where they overlap and differ from one another. In addition, the recent initiative and pilots from the FDA will be discussed. The author will also reflect on their experience participating in both stakeholders’ groups and lessons learned that could benefit other Industry committees.

European Medicines Agency Policy 0070: An Exploratory Review of Data Utility in Clinical Study Reports for Academic Research

Abstract: EMA Policy 0070 requires sponsors to demonstrate careful consideration of data utility within anonymised CSRs published within the scope of the Policy, yet the concept of data utility is not clearly defined in the associated anonymisation guidance.

The objective of this work was to review of the objectives, research methodologies and findings of 13 academic research reports using unpublished data from CSRs (prior to EMA Policy 0070) and to hypothesise the potential data utility of CSRs anonymised under the objectives of EMA Policy 0070 for future academic research.

The research purposes ranged from assessment of reporting bias, comparison of methods and results with published data sources, detailed evaluation of harm and adverse events, re-analysis and novel analyses including systematic reviews and meta-analysis.