Impact of the New European Regulation on Clinical Trials in the Activity of Research Ethics Committees from Catalonia (Spain)

Abstract

Different legislations have regulated Clinical Trials (CT) in Spain. The last European regulations have substantially impacted on the Research Ethics Committees (RECs), especially the latter, Regulation (EU) No536/2014. Spain was the first European country to apply this new regulation, so the aim of
this study was to analyze its impact on the activity of RECs from Catalonia, comparing it with previous
legislation. Annual activity reports (number of meetings and CTs evaluated) were analyzed. Two periods
(coinciding with different legislations) were established. Kruskal-Wallis and MANOVA factor tests were
used (p < 0.05). 420 reports from 47 RECs were reviewed. There were no changes in number of meetings
(p = 0.329), but a sharp decrease in number of CT evaluations was observed in second period (p < 0.001).
In conclusion, new legislation has had an impact on Catalan RECs. The number of evaluation activities
have shown fluctuations over years, but the decrease has become more evident nowadays.