Does the European clinical trials directive really improve clinical trial approval time?

摘要

AIMS: To facilitate and improve clinical research within Europe, the European Union (EU) adopted in 2001 the Clinical Trials Directive (EUCTD). The aim of this study was to compare duration between submission of a clinical drug trial application and approval by regulatory authorities in EU countries regulated by EUCTD vs. EU countries regulated by local legislation and, second, to compare the duration of regulatory approval in Europe vs. the USA and Australia. METHODS: Application for clinical drug trial initiation was submitted to the regulatory authorities of 14 European countries, to the USA and to Australia. In Europe, 10 countries were regulated by EUCTD and four by local legislation. RESULTS: In Europe, the median duration of regulatory procedures was longer in EUCTD countries compared with countries following local legislation (75 vs. 59 days; P < 0.001). Five EUCTD countries had a time to approval of >60 days (maximum within EUCTD rules). The long duration of regulatory procedures was the consequence of (i) sequential instead of simultaneous submission of trial application to regulatory authorities, and (ii) involvement of local ethics committees in procedures that should be followed only by central ethics committees. The duration of regulatory procedures was similar in Australia (67 vs. 68 days, P = 0.388), but significantly shorter in the USA (67 vs. 15 days, P < 0.001). CONCLUSIONS: In this early stage of implementation, EUCTD appears not to shorten the duration of regulatory procedures for clinical trial initiation. Furthermore, Europe lags behind the USA in speed of regulatory procedures.