In June 2019, the European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) co-signed a letter reminding all sponsors of clinical trials conducted in the European Union (EU) of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT).
If you are conducting a clinical trial, don’t forget to take in account that:
- The submission of the results to EudraCT is the direct responsibility of the sponsors.
- The result-related information should be posted within one year (6 months for paediatric trials) after the end of a clinical trial.
- Although the results of phase I trials, which are conducted solely in adults and are not part of an agreed PIP, will not be published in the EU Clinical Trials Registry, the data must be entered into the EudraCT database.
For “old” trials registered in EudraCT that ended before 21st July 2014 of which results have not been published, the results should be provided! The result-related information is posted to EudraCT in one or both of two modalities: full data set and/or summary attachment. It depends on whether the trial involves paediatric population and agreed PIPs and when the trial ended.
Any help you might need with data entry of results for phase I-IV clinical trials in EudraCT (full data set) and/or submission of summaries for retrospective trials including redaction of the documentation if needed, Asphalion would be more than happy to support you.
Please contact us at [email protected]