Internationally, the issue of including women in clinical trials of medicines has been addressed in various guidelines issued by the International Conference on Harmonization (ICH), which promotes regulatory standards for clinical trials. While ICH has specific guidelines on the conduct of clinical trials in paediatric and geriatric populations, there are no consolidated guidelines for the investigation of medicinal product in women.
Taking Action to Improve the Evidence Base for Policies by Changing Gender Imbalances in the Content and Process of Health Research.
What are the mechanisms behind gender imbalances in the contents and processes of health research?
Gender discrimination and bias not only affects differentials in health needs, health seeking behaviour, treatment, and health outcomes but also influences the content and the process of health research.
Mühlenbruch B, Jochimsen MA. Nature. 2013 Mar 7;495(7439):40-2.
Providing equal opportunities for women in science requires change at every level, argue Brigitte Mühlenbruch and Maren A. Jochimsen.
Gender-equality policy in science at European regional and national level has come a long way, thanks to more than 20 years of efforts by women scientists and far-sighted politicians. Yet progress is slow. The pipeline is still leaking and female researchers still hit glass ceilings.
Since the thalidomide tragedy in the late1950s, there has been a reluctance to include women of childbearing age in clinical trials. However, this fear cannot be used as an excuse to not include females in clinical trials, and, with proper care and regulation, increased female participation has been reached. The United States adopted regulation early on to increase the participation of women, while a new regulation in Europe is going to improve this as well. Here follows an overview of the issue in Canada and in the USA. The third part of this series will deal with new regulation in Europe.
Horizon 2020 Advisory Group on Gender. Rev. 30 March 2015.
The mandate of the AG Gender is to provide advice to other AGs and to the Commission on the integration of the gender dimension in research content pertaining to all activities where it is relevant, as well as its possible interactions with other crosscutting issues. As part of our advice, we have prepared this paper for use during the preparation of the Horizon 2020 work programmes,
