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.

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.

Topic: 
Subscribe to clinical trials

MMLAP and other EU Projects

Health system analysis to support capacity development in response to the threat of pandemic influenza in Asia
Making society an active participant in water adaptation to global change
Public Participation in Developing a Common Framework for Assessment and Management of Sustainable Innovation
Effective communication in outbreak management: development of an evidence-based tool for Europe
Developing the framework for an epidemic forecast infrastructure
European monitoring of excess mortality for public health action
Modelling the spread of pandemic influenza and strategies for its containment and mitigation
Cost-effectiveness assessment of european influenza human pandemic alert and response strategies
Bridging the gap between science, stakeholders and policy makers
Promotion of immunization for health professionals in Europe
Towards inclusive research programming for sustainable food innovations
Medical ecosystem – personalized event-based surveillance
Studying the many and varied economic, social, legal and ethical aspects of the recent developments on the Internet, and their consequences for the individual and society at large
Knowledge-based policy-making on issues involving science, technology and innovation, mainly based upon the practices in Parliamentary Technology Assessment
Assessment of the current pandemic preparedness and response tools, systems and practice at national, EU and global level in priority areas
Analysis of innovative public engagement tools and instruments for dynamic governance in the field of Science in Society
Public Engagement with Research And Research Engagement with Society
Computing Veracity – the Fourth Challenge of Big Data
Providing infrastructure, co-ordination and integration of existing clinical research networks on epidemics and pandemics
Creating mechanisms for effectively tackling the scientific and technology related challenges faced by society
Improving respect of ethics principles and laws in research and innovation, in line with the evolution of technologies and societal concerns
Creating a structured dialogue and mutual learning with citizens and urban actors by setting up National Networks in 10 countries across Europe
Identifying how children can be change agents in the Science and Society relationship
Establishing an open dialogue between stakeholders concerning synthetic biology’s potential benefits and risks
Transparent communication in Epidemics: Learning Lessons from experience, delivering effective Messages, providing Evidence