April 2022: What are European Drug Regulators Doing to Promote Clinical Trial Reporting? – A TranspariMED Article

An article “What are European drug regulators doing to promote clinical trial reporting?” has been published on April 25, 2022, on TranspariMED.

It informs that Health Action International, the Transparency International Global Health Programme, Universities Allied for Essential Medicines (UAEM) Europe, and TranspariMED sent a letter to key ten European Union countries (Austria, Belgium, Denmark, Finland, France, Germany [two regulators: BfArM and PEI], Italy, Netherlands, Spain, and Sweden) asking for their efforts in reporting clinical trials. These countries have the largest number of missing clinical trials data as per DeVito et al 2021.

The letter seeks information from the drug regulators regarding regulatory strategies and reinforcement mechanisms planned for reporting the missing clinical trials data. It asks to provide how the Regulation has been integrated into national legislation and the national competent authority sanctioning processes, especially after the implementation of EU CTR. Also, to provide data reporting requirements for a non-drug clinical trial.

It also includes 11 questions regarding the above topics along with questions to provide a number of clinical trials lacking results, correct completion dates, penalties for infringement, and the steps taken to encourage sponsors’ compliance for reporting clinical trials data on EudraCT.