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.
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.
Attention to sex and gender in biomedical, health and clinical research is an important quality and safety issue. Medicinal products are safer and more effective for everyone when clinical research includes diverse population groups. Historically, women’s health issues have focused on reproductive health, followed by gender issues such as behaviour, socio-economic factors, culture, lifestyles and influence biological development and health.
Many clinical trials, even those on vaccines, are currently being made without considering the immunological differences that can exist between men and women. Katie Flanagan, senior lecturer of the Department of Immunology at Monash University, in Melbourne, Australia, explains how, and why this needs to be changed.
Declaring an emergency is a dirty work, but someone has to do it. When facing a serious threat to global public health, even if complete evidence is lacking, someone has to take the responsibility to push the red button that activates a chain of coordinated actions (such as cooperation among states and research on vaccines). Choosing to do this, the risk of giving a false alarm is unavoidable.
The Zika virus has been recently identified in Europe after having spread in Brazil, where its first infection was confirmed in March 2015. Despite being relatively mild, this virus is now making headlines, as it could be responsible of a large increase of microcephaly among infants. A connection that pushed Brazil to declare Zika a public health emergency.
The consideration of sex and gender are not the most obvious issues that come to mind when discussing epidemics and pandemics. However, sex and gender have an important impact on these issues, since barriers to pandemic preparedness and risk behaviour can often be better understood when viewed from a sex and gender perspective.
Both gender and sex have an impact on experiences and behaviours relating to pandemics, epidemics and vaccination. The difference between sex and gender can be confusing, and the two words are often incorrectly used interchangeably.
