Italian Regulators Call for Clinical Data to be Disaggregated by Gender
The Italian national regulatory agency, AIFA, has called upon pharmaceutical companies to include gender-disaggregated data in the submission of regulatory documents, including marketing approval applications, so as to highlight any differences.
The agency explained that preclinical and clinical research provided by the pharmaceutical industry to regulatory agencies often does not show efficacy and safety data by gender.
AIFA noted that analysis of the female population could be further broken out by age, which is a potential source of variation in the response to drug therapy.
Recent international literature has focused on the differences between therapeutic responses as men and women, and in particular how those differences relate to safety.