[Data and reflections on the current process of the multicenter clinical trial assessment in Spain]

The European Directive 2001/20/EC was intended, among other things, to simplify and accelerate the start of multicenter clinical trials (MCT) in all European Union countries. The Spanish regulation in force since May 2004 has failed to achieve this. Because there is not a real single opinion in Spain, as given by a single Research Ethics Committee, a key point to accelerate the MCT assessment, less than 50% of the protocols are assessed in the maximum time of 60 days established by the Directive. As a consequence in 2005 up to 29% of investigators (twice as much as in 2003 percentage) had no time to recruit patients in the MCT, since when the ethical-administrative process is finally completed, the recruitment period has almost concluded, or even has finalized internationally. Likewise, a 37% reduction in the percentage of investigators recruiting > 90% of committed cases in MCT was observed between 2003 and 2005. All these differences are statistically significant (p < 0.0001). These figures clearly show that Spain needs urgent changes in the current regulation of MCT to be competitive in clinical research in Europe.