European Regulators urge sponsors to publish results in EU clinical trials database

5th July 2019 (Last Updated July 5th, 2019 14:02)

The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have co-signed a letter urging all sponsors of clinical trials conducted in the European Union (EU) to publish the results in the EudraCT database.

The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have co-signed a letter urging all sponsors of clinical trials conducted in the European Union (EU) to publish the results in the EudraCT database.

According to the EMA, transparency to clinical trial results, whether positive or negative, is fundamental for the protection and promotion of public health.

It assures trial subjects that their voluntary participation in clinical trials is useful and that the results have been collated and reported for the benefit of all, EMA said.

Additionally, for those drugs which are placed on the market or used in further clinical trials, the database allows patients, healthcare professionals, and any other citizen, to gain more knowledge on the medicines they might be taking or prescribing.

This way, the clinical research can be advanced in a better manner and also support medicine development programmes.

EMA advised sponsors to ensure that the protocol information and results of all clinical trials submitted in EudraCT is publicly accessible through the EU Clinical Trials Register (EU CTR).

This clinical trial information is also shared with the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP) of which EU CTR is considered to be the primary registry.

The EudraCT database included a total of 57,687 clinical trials as of this April. Among these, 27,093 were completed. Out of them, 18,432 are yet to have results posted.

The reporting compliance of non-commercial sponsors (academic sponsors) was much lower, compared to commercial sponsors (major pharmaceutical companies), with 23.6% of results posted for non-commercial sponsors versus 77.2% for commercial sponsors.

Academic sponsors or smaller pharma companies often lack awareness or incentives to publish clinical results. To overcome this issue, EU authorities are taking necessary steps to ensure they are aware of their obligations and act accordingly.