title: Are women appropriately represented and assessed in clinical trials submitted for marketing authorization? A review of the database of the European Medicines Agency.
abstract: 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 submitted to the EMEA there was no, or generally clinically negligible, evidence for gender bias; however, women were underrepresented in hypertension, diabetes and hepatitis B trials, and overrepresented in rheumatoid arthritis and allergic conjunctivitis.
  
  
  CONCLUSIONS
  In trials submitted for marketing authorization to the EMEA gender bias was not a serious problem.
authors: Austria Medicines and Medical Devices Agency/AGES PharmMed, Vienna, Austria. marcus.muellner@ages.at
authors: M
authors: M
authors: Müllner
authors: S
authors: S
authors: Vamvakas
authors: M
authors: M
authors: Rietschel
authors: B J
authors: BJ
authors: van Zwieten-Boot
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D016208:Databases, Factual; D017277:Drug Approval; D004345:Drug Industry; D005060:Europe; D005260:Female; D006077:Government Agencies; D006801:Humans; D008297:Male; D018579:Patient Selection; D011287:Prejudice; D018570:Risk Assessment; D017678:Sex Distribution; D016387:Women's Health