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

ABSTRACT:

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 EUC

SUBMITTER: Lambers Heerspink HJ 

PROVIDER: S-EPMC2561118 | biostudies-literature | 2008 Oct

REPOSITORIES: biostudies-literature