Are women appropriately represented and assessed in clinical trials submitted for marketing authorization? A review of the database of the European Medicines Agency.

@article{Muellner2007AreWA,
  title={Are women appropriately represented and assessed in clinical trials submitted for marketing authorization? A review of the database of the European Medicines Agency.},
  author={Marcus Muellner and Spiros Vamvakas and Marcella Rietschel and Barbara van Zwieten-Boot},
  journal={International journal of clinical pharmacology and therapeutics},
  year={2007},
  volume={45 9},
  pages={477-84}
}
OBJECTIVE There is concern that patients included in trials do not represent the true patient population and women in particular may selectively be excluded. We looked at trial data submitted to the European Medicines Agency (EMEA) by drug companies to achieve marketing authorization in Europe between 2000 and 2003. METHODS We reviewed the EMEA database and included the main studies for the risk/benefit assessment (pivotal trials) submitted between 2000 and 2003. RESULTS In pivotal trials… CONTINUE READING