EU clinical trial database needs back-up system says pharma industry

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) has called for the creation of a backup system to the European Union’s (EU) clinical trial database and portal, in case of technical failures.

In formal public consultation comments on the operation of the harmonised clinical trial data reporting system created under the EU’s 2014 clinical trial regulation (536/2014), EUCOPE asked: 'In case the portal breaks down…would it perhaps be possible to submit via Eudralink in such an instance?' The Confederation also asked if for each trial, one identification number could be assigned to help identify global studies registered in multiple international registers.

The German Pharmaceutical Industry Association agreed that contingency plans were needed. If the database or portal failed, 'it is absolutely necessary and a basic requirement that immediately appropriate communication, data submission and flow of information will be maintained' between regulators, industry, ethics committees and others, to ensure all deadlines are met, it said.

European Federation of Pharmaceutical Industries and Associations (EFPIA) Regulatory Affairs Director Sini Eskola suggested that additional functions could be considered for the EU’s clinical trial database. This, she said, 'could include an automatic notification mechanism on newly authorised clinical trials for patients and healthcare following specific subscription'. This would allow patient and healthcare professionals to keep informed on new clinical trials.