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EudraCT Results Reporting

Thomas Wicks

December 9, 2014

DECEMBER 9, 2014

In October 2014, the European Medicines Agency published its final policy on publication of clinical trial data. Prior to finalization and during the public consultation period the agency received over 1,000 comments from stakeholders.

From a process perspective, many sponsors were interested in seeing how the European clinical trial results disclosure policy compared to their current clinical trial disclosure initiatives toward the U.S. registry, The TrialScope team studied the policies and determined the following:

In a field by field analysis, we found that about 52 percent of the data can be mapped from the CTA or results, while about 39 percent represents unique data fields that cannot be mapped. The remaining approximately 9 percent of the fields are either auto-generated in the form, or could possibly be mapped from the protocol registration form.

To better understand the nuances of this information, the team also conducted a content analysis based on character counts. The team found that although only about 52 percent of the fields can be mapped from the CTA or results forms, these fields represent about 80 percent of the content.

This analysis shows us that there are potential process, time and resource savings when we look at managing and preparing clinical trial disclosure data and clinical trial results disclosure for multiple registries. 

About the author

Thomas is responsible for tracking regulatory and market trends that shape TrialScope’s clinical trial disclosure and transparency solutions. He has more than 23 years of experience with performance and content management solutions, specializing in applications for life sciences such as clinical trial disclosure, structured product labeling and submissions management. Thomas has been focused on trial transparency since 2007.