Gender differences in clinical registration trials: is there a real problem?

ABSTRACT:

Aims

Several studies have reported the under-representation of women in clinical trials, thereby challenging the external validity of the benefit/risk assessments of launched drugs. Our aim was to determine the extent to which women have been included in clinical trials used for drug registration and to analyse the fraction of women participating in phases I, II and III.

Methods

We conducted cross-sectional, structured research into publicly available registration dossiers of Food and Drug Administration (FDA)-approved drugs that are prescribed frequently. Furthermore, we analysed compounds with high hepatic clearance and a known gender-related difference in drug response. In a sensitivity analysis, we compared figures with US disease prevalence data.

Results

For 38 o

SUBMITTER: Labots G 

PROVIDER: S-EPMC5867082 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature