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clinical trials

Gender integration in Horizon 2020

Tuesday, June 20, 2017 - 09:04

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:

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Target: 
Decision Makers, Government and Public Health
Topic: 
Gender, Human Rights, Mutual Learning, Policy, Prevention, Stakeholders
Tags: 
gender, gender issues, science and society, clinical trials, Horizon 2020, research

Sex and gender in clinical trials

Tuesday, May 23, 2017 - 18:49

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.

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Target: 
Government and Public Health
Topic: 
Gender
Tags: 
Dataviz, gender issues, clinical trials

Sex, clinical trials and medicines regulation part III

Thursday, January 19, 2017 - 11:01

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.

  • Read more about Sex, clinical trials and medicines regulation part III
Target: 
Government and Public Health, Healthcare Professionals
Topic: 
Gender, Human Rights, Policy, Stakeholders
Tags: 
gender issues, clinical trials, policy, transparency

Sex & Gender: The Politics, Policy, and Practice of Medical Research

Keitt SK. Yale J Health Policy Law Ethics. 2003 Summer;3(2):253-78.

Topic: 
Gender
Tags: 
Sex, gender, ​research, clinical trials, policy, law
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ICH - Gender Consideration In The Conduct Of Clinical Trials

EMEA - European Medicines Agency. January 2005.

Topic: 
Gender
Tags: 
gender, clinical trials, ICH guidelines
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Sex, clinical trials and medicines regulation part II

Friday, December 30, 2016 - 10:24

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.

  • Read more about Sex, clinical trials and medicines regulation part II
Target: 
Decision Makers, Government and Public Health
Topic: 
Gender, Prevention, Stakeholders, Treatment, Vaccination
Tags: 
gender issues, clinical trials

Reporting Sex, Gender, or Both in Clinical Research?

Clayton JA, Tannenbaum C. JAMA. November 8, 2016

Target: 
Healthcare Professionals
Topic: 
Gender
Tags: 
Sex, gender, clinical trials
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Sex, clinical trials and medicines regulation: part I

Monday, November 28, 2016 - 14:39

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.

  • Read more about Sex, clinical trials and medicines regulation: part I
Target: 
Government and Public Health, Healthcare Professionals
Topic: 
Gender, Prevention, Treatment, Vaccination
Tags: 
gender issues, clinical trials, Vaccine

Consider sex in clinical trials

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.

Target: 
Healthcare Professionals
Topic: 
Gender
Tags: 
Video, gender issues, clinical trials
  • Read more about Consider sex in clinical trials

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Action plan on Science in Society related issues in Epidemics and Total pandemics
European Commission
This project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 612236.

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