Gender

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.

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

ICH - Gender Consideration In The Conduct Of Clinical Trials

EMEA - European Medicines Agency. January 2005.

Topic: 
Gender
Tags: 
gender, clinical trials, ICH guidelines

​Policy Brief #5: Gender Imbalances in Health Research

The ENGENDER Project. October 2011.

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.

 

Topic: 
Gender
Tags: 
gender, research, equity, policy

Research policy: Only wholesale reform will bring equality.

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.

Topic: 
Gender
Tags: 
gender, equality, policy, science

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.

Target: 
Decision Makers, Government and Public Health
Topic: 
Gender, Prevention, Stakeholders, Treatment, Vaccination
Tags: 
gender issues, clinical trials

For a better integration of the gender dimension in Horizon 2020 Work Programme 2016-2017.

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,

 

Topic: 
Gender
Tags: 
gender, Horizon 2020

Guidance on Gender Equality in Horizon 2020

European Commission. Directorate-General for Research & Innovation. Version 2.0;22 April 2016.

Topic: 
Gender
Tags: 
gender, equality, guide, Horizon 2020

Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use.

Heidari S, Babor TF, De Castro P, Tort S, Curno M. Research Integrity and Peer Review. 2016 May 3;1:2. 

Topic: 
Gender
Tags: 
Sex, gender, guidelines, scientific research, scientific publishing

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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