Knowing which countries to submit clinical trial results summaries to is the easy part. What becomes difficult is learning the intricacies and transparency requirements of every clinical trial registry globally, including the European Union electronic register of post-authorization studies (EU PAS Register). Here is an overview of this registry:
Registry name: The European Union electronic register of post-authorization studies (EU PAS Register)
Year established: 2011
Country: European Union
Points of interest:
- The EU PAS Register is a publicly available register of non-interventional post-authorization studies, focused on observational research
- The register is controlled by the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
- ENCePP was established by the European Medicines Agency (EMA) and the EU regulatory network, with a goal to facilitate independent and transparent post-authorization monitoring of European medical products.
- Protocol registration and trial results disclosure for all studies initiated after July 2, 2012 is mandatory in the EU PAS for non-interventional post-authorization safety surveillance studies, non-interventional post-authorization efficacy studies, ENCEPP Seal studies, imposed non-interventional PASS (i.e., Category 1 and Category 2), and imposed non-interventional PAES
- It is recommended that protocol registration occur prior to study start
- In regards to a data sharing plan, the study questionnaire includes a question regarding sources of data, and the investigator is asked to provide a brief description of the data analysis plan. There is no obligation to disclose the data sharing plan as of the date that this blog article is published
Related transparency research/articles:
- An analysis of characteristics of post-authorization studies registered on the ENCePP EU PAS Register
- Reporting guiding for pharmacoepidemiological studies are urgently needed
- FAQ – EU PAS Register
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