The new Royal Decree Law allows for a 19% time reduction when starting a new clinical trial in Spain

The Royal Decree Law 1090/2015 regulating clinical trials has allowed, since its coming into force last January 13, that the time needed to kick off a new clinical trial in Spain is reduced by more than a month (19%) in Spain, reported the trade group Farmaindustria.

This is reflected in the data from the BEST project’s , updated on June 30th this year, which was presented today in Barcelona, during the 1st National Meeting of ethic committees in medicines research (CEIm), organized by the Spanish Medicines Agency (AEMPS) in collaboration with the Spanish Clinical Pharmacology Society. The pharmaceutical industry is confident that these timelines will be further reduced in the upcoming months.

The BEST project, started more than 10 years ago, gathers together 45 pharmaceutical companies, 13 Spanish Regions, 57 hospitals, both public and private, as well as  four independent research groups. The figures released today demonstrate that all agents participating in this initiative have undertaken great efforts to adjust to the timelines established in the new Royal Decree. The reduction of the timelines needed to set up a new clinical trial in Spain is a direct consequence of these efforts, passing from an average 190 days with the former regulation to 154 in the first semester of 2016, which stands for 19% less time.