Those are the findings of an investigation by TranspariMED, an advocacy group that asked the regulatory agencies in 10 European countries to share details of their efforts to encourage the publication of clinical trial results. The investigation provides a look at the state of play in wake of the implementation of two regulations, covering clinical trials and medical devices, that feature transparency requirements.
TranspariMED learnt that the regulatory agencies in six countries—Austria, Belgium, Denmark, Finland, Germany and the Netherlands—are actively working to fill the gaps in the record of results. In Belgium, for example, the regulatory agency receives a list from the European Medicines Agency and contacts sponsors that are yet to report their results to EudraCT.
All six countries have legal frameworks covering the need for sponsors to report clinical trial results. The penalty for noncompliance is highest in Belgium, where authorities can fine sponsors up to €250,000.
The initiatives undertaken by the six countries have been “remarkably successful,” TranspariMED said, but they are not being replicated across the European Union. Three regulatory agencies, in France, Italy and Spain, did not respond to TranspariMED’s “repeated requests for information.” A fourth, in Sweden, responded, revealing the country has a legal framework, but was lumped in with the nonresponders.
Lacking information on the activities in France, Italy and Spain, TranspariMED analyzed registry data to understand whether they are effectively promoting data reporting. The analysis revealed “continued weak reporting performance by many sponsors” and “widespread data quality problems.” Eighty percent of the large trial sponsors with very weak reporting records are based in Italy and France.
TranspariMED warned that the four countries, which it said “appear to be taking little or no action on missing drug trial results,” could “undermine European efforts to secure the 3,055 drug trial results that are still missing.”