January 2022: Clinical Trial Transparency in Belgium – A TranspariMED Report

A new report launched on January 21, 2022, by three Belgian groups – Cochrane Belgium, consumer group Test Ankoop, and patient group Kom op tegen Kanker – in collaboration with TranspariMED enlists details on Federal Agency for Medicines and Health Products (FAMPH) plans to promote clinical transparency.

The report discusses the clinical trial results reporting the performance of the 9 Belgian non-profit institutions that conduct many clinical trials. It also states in detail the efforts made by Belgium’s national medicines regulator, FAMPH, to encourage the publication of trial results. Results for a trial conducted in Europe or EEA region must be reported on EudraCT within one year of trial completion per European Directive 2001/20/EC.

Report findings show that the Belgian sponsors’ estimated true combined results reporting rate of 43% puts them far ahead of their peers in the Netherlands, whose reporting rate is just 7%. However, this rate still lags other European countries whose results reporting rate is up to 60%.

The article concluded by stating that the Belgian sponsors have made substantial progress, but the trial registry entries still require accuracy and consistency. The report also provides “Recommendations” to improve the quality of Belgian data on the registry.

For more information, please refer to the article published on 21 January 2022 on TranspariMED.