clinical trials

Gender is considered a main issue in Horizon 2020, the largest ever EU Research and Innovation programme, with €80 billion worth of funding available over seven years. The European Commission has identified seven priority areas of societal challenges, with the goal targeting investment in research in these fields. They are:

It is often said that sex and gender differences are perceived as overlooked in research design and in clinical trials, even those on vaccines. In 2010, the World Health Organisation (WHO) published the document Sex, gender and influenza, which states that many reports of influenza vaccination rates as well as the safety, efficacy and effectiveness of vaccines around the world do not disaggregate data by sex.

Gender issue in clinical trials in Europe

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.

An underlying principle of drug development is that “patients entering clinical trials should be reasonably representative of the population that will be later treated by the drug” as subpopulations may respond differently to a given drug treatment. 
While ICH has developed specific guidelines that deal with the participation of geriatric and pediatric subjects in the drug development process, this has not been the case for the clinical investigation of medicinal products in women. Direct and indirect references to gender do, however, appear throughout a number of ICH guidelines.

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Drug Approval Regulation in Canada and USA

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.

July 13, 2016

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.

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