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 1000 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 US registry, www.clinicaltrials.gov. The TrialScope team studied the policies and determined the following:
In a field by field analysis, we found that about 52% of the data can be mapped from the CTA or clinicaltrials.gov results, while about 39% represents unique data fields that cannot be mapped. The remaining ~9% of the fields are either auto-generated in the form, or could possibly be mapped from the clinicaltrials.gov protocol registration form.
To better understand the nuances of this information, the team also conducted a content analysis based on character counts. They found that although only about 52% of the fields can be mapped from the CTA or clinicaltrials.gov results forms, these fields represent about 80% 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. If you are interested in a further analysis comparing the data requirements for US clinical trial results reporting and EudraCT results reporting in the EU, please check out the data mapping presentation I recently gave to EFPIA.