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Sex and gender in clinical trials

Photo: Kate Holt / AusAID (Flickr)

Tuesday, May 23, 2017 - 18:49

Target

Government and Public Health

Topic

Tags

clinical trials

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.

Experts from the ASSET project performed a study to compare participation rates of males and females in clinical vaccine trials. Based on available data, this comparison shows that there are no significant differences in participation rates of males and females in clinical vaccine trials, also analyzing data by trial phase. However, the fact that only a minority of the trials disaggregated data by sex and gender is a highly relevant finding, for it indicates that such a distinction was not perceived as important. It would thus be interesting to know why these data have not been reported and if the inclusion of sex-disaggregated data and gender analysis would have given different results.

All readers are invited to actively participate to the data visualization, drawing a line that show a supposed females participation rates in clinical vaccine trials according to their opinion and comparing it with the actual graphical representation of data.

MMLAP and other EU Projects

AsiaFluCap Health system analysis to support capacity development in response to the threat of pandemic influenza in Asia	BEWATER Making society an active participant in water adaptation to global change	CASI Public Participation in Developing a Common Framework for Assessment and Management of Sustainable Innovation	CIMULACT Engaging all of Europe in shaping a desirable and sustainable future	DARWIN Expect the unexpected and know how to respond
DRIVER Driving innovation in crisis management for European resilience	ECOM Effective communication in outbreak management: development of an evidence-based tool for Europe	EDEN Solutions to improve CBRNe resilience	EPISOUTH Network for Communicable Disease Control in Southern Europe and Mediterranean Countries	EPIWORK Developing the framework for an epidemic forecast infrastructure
EUPHARE Strengthening of the national surveillance system for communicable diseases	EUROHEP Surveillance of vaccine preventable hepatitis	EuroMOMO European monitoring of excess mortality for public health action	EURONHID European network for highly infectious disease	EUVAC.NET Dedicated surveillance network for surveillance and control of vaccine preventable diseases in the EU
FLUMODCONT Modelling the spread of pandemic influenza and strategies for its containment and mitigation	FLURESP Cost-effectiveness assessment of european influenza human pandemic alert and response strategies	GAP2 Bridging the gap between science, stakeholders and policy makers	HProImmune Promotion of immunization for health professionals in Europe	INPROFOOD Towards inclusive research programming for sustainable food innovations
JA-CHRODIS Addressing chronic diseases and healthy ageing across the life cycle	M-Eco Medical ecosystem – personalized event-based surveillance	MAPPING 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	MARINA Get involved in the responsible marine research and innovation	PACITA Knowledge-based policy-making on issues involving science, technology and innovation, mainly based upon the practices in Parliamentary Technology Assessment
PANDEM Assessment of the current pandemic preparedness and response tools, systems and practice at national, EU and global level in priority areas	PE2020 Analysis of innovative public engagement tools and instruments for dynamic governance in the field of Science in Society	PERARES Public Engagement with Research And Research Engagement with Society	PHEME Computing Veracity – the Fourth Challenge of Big Data	PREPARE Providing infrastructure, co-ordination and integration of existing clinical research networks on epidemics and pandemics
PROMOVAX Promote vaccinations among migrant population in Europe	R&DIALOGUE Creating mechanisms for effectively tackling the scientific and technology related challenges faced by society	RESPIRE Improve the quality of indoor air, keeping it free from radon	SATORI Improving respect of ethics principles and laws in research and innovation, in line with the evolution of technologies and societal concerns	SECURING CITIES AGAINST GLOBAL PANDEMICS Investigating how cities in the West securitise against global pandemics
SEiSMiC Creating a structured dialogue and mutual learning with citizens and urban actors by setting up National Networks in 10 countries across Europe	SIS CATALYST Identifying how children can be change agents in the Science and Society relationship	SYN-ENERGENE Establishing an open dialogue between stakeholders concerning synthetic biology’s potential benefits and risks	TELLME Transparent communication in Epidemics: Learning Lessons from experience, delivering effective Messages, providing Evidence

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Contacts

Contacts

General inquiries: info@asset-scienceinsociety.eu

ASSET

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.