Balancing Utility and Privacy in EMA Policy 0070 Submissions
December 5, 2016
The EMA’s Clinical Data portal has just gone live. This portal fulfills one of the elements in the EMA Policy 0070 on sharing clinical trial data: it allows data users to access clinical reports with a minimalist registration process. Effectively, the EMA has made these documents publicly available. It is the first time any regulator has attempted to establish a proactive process for disseminating trial data. Many stakeholders reacted positively, however, the devil is in the details. In this webinar we review the documents that were posted on the Clinical Data portal, describe how they have been anonymized, review the anonymization techniques and what can be learned from this initial set of document releases.
By performing this review, we hope to foster dialogue about how to continue improving clinical trial data sharing practices by:
- Ensuring that shared documents are useful for secondary analysis;
- Protecting patient privacy; and,
- Allow sponsors to manage their legal liability.
To watch this 50 minute webinar, please fill out the form on the right.