In hopes of cutting clinical trial costs and red tape, the European Commission next week plans to propose new rules that would make it easier for drugmakers and researchers to conduct cross-border studies. The move comes in response to data showing the number of clinical trials carried out in the European Union fell by 15 percent in recent years, while administrative costs and delays have doubled,Reuters writes.
Under existing rules, a drugmaker or researcher planning to run clinical trials in more than one EU member state must often submit separate applications in each country where the trial is going to be conducted. The requirement, which went into effect in 2001, was designed to bolster monitoring and reporting, but has also been blamed for rising costs and administrative hassles, Reuters notes.
European Union health and consumer commissioner John Dalli tells Reuters the new rules, which will be presented on July 17, will introduce a so-called harmonized EU submission system for clinical trials, which means applicants will only have to submit information once. The EC is also expected to replace the current EU directive, which each member state must incorporate into its own national law, with one regulation applying equally in all 27 countries.
Cross-border trials are important for testing treatments for rare diseases, because there are often too few potential trial participants in a given country, Reuters points out. About 25 percent of all EU trials currently involved work that is conducted in between three and five countries, according to the EC. Once published, the EC proposal will have to be jointly agreed by all EU governments and the European Parliament, which could take up to two years.
Peter Liese, a German member of the Parliament and health spokesman for the centre-right EPP group, tells Reuters he wants to correct the original rule because this prompted trial work to gravitate toward poorer countries, such as India. He worries that overseas standards, which must be equivalent to EU standards, are difficult to verify and argues that foreign trials should therefore not be used to approve new medicines.
"It's a delicate balance, but we think we have a responsibility there for the poor people that risk their life in India, but also for the patient in Europe that might not be treated in the optimal way when the data are not generated under reliable conditions," Liese tells the news service.