Development in the number of clinical trial applications in Western Europe from 2007 to 2015: retrospective study of data from national competent authorities.

ABSTRACT:

Objective

To investigate the development in the number of applications for authorisation of clinical trials of medicines (CTAs) submitted annually to national competent authorities in 10 Western European member states of the European Union from 2007 to 2015.

Design

Registry study.

Setting

Data from national competent authorities.

Participants

Germany, Italy, Spain, France, the UK, Belgium, the Netherlands, Austria, Denmark and Sweden. Inclusion criteria were Western European member states of the European Union, receiving more than 200 CTAs per year.

Outcome measures

Summarised number of CTAs and distribution of CTAs by type of sponsor (commercial or non-commercial) and trial phase (I-IV). Average annual growth rates (AAGRs) based on linear regressions. D

SUBMITTER: Dombernowsky T 

PROVIDER: S-EPMC5734571 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature