European Clinical Trials Directive under fire
The recently established database created by the European Clinical Trials Directive (EUDRACT) has come under fire from the European Science Foundation (ESF), which claims that its information is too tightly controlled to allow effective debate.
The recently established database created by the European Clinical Trials Directive (EUDRACT) has come under fire from the European Science Foundation (ESF), which claims that its information is too tightly controlled to allow effective debate.
Although the EUDRACT database was set up to provide EU member states with information on the safety of medicines used in clinical trials, data security standards set by the European Commission prevent independent non-regulatory organisations from accessing it.
According to the ESF, (a co-ordinating group for European scientists and researchers), this contrasts poorly with national registers in the US and the UK, which are more open. 'Increased openness about clinical trials between the public and the medical research community would help to improve the quality and relevance of clinical trials in Europe,' said the ESF. It wants wider access to EUDRACT, saying 'research funding agencies, as well as pharmaceutical companies, need reliable information about all studies to make the right decisions' avoiding duplication, and promoting replication and collaboration.