Sunday, June 10, 2018

Research, Innovation and Personalised Medicine 4/6. European Plan for Women’s Health 2018



10. Cross-National Data Cross-national data collection across the EU must be improved and expanded.  Data must be formatted in a manner that can easily be processed and interchanged between local, national and EU levels.  Robust, comparable data is essential, and EU Member States should be encouraged to work to standard templates for data collection.  Templates should include common indicators, capturing patterns of behaviour and access to resources, which can be utilised by healthcare delivery organisations and channeled through regional and national statistics to the EU level.   Current efforts like the Cancer Registries should be supported and improved to fix existing gaps.  Comprehensive, longitudinal data is essential for improving health and wellbeing policy, programmes and practice.

 11. Sex and Gender Disaggregation Large differences exist between men and women with regard to prevention, disease development and progression, diagnosis, treatment and care of various health conditions.  Yet, there is a lack of comparable cross-national health data that sufficiently disaggregates by factors, including sex and gender, age and ethnicity.  Robust age as well as sex and gender analysis of data is often lacking, resulting in gaps in evidence-based medicine and research.  In order to improve existing policy and practice, research should be based on sex and gender as well as age disaggregated data.  Harmonised sex and gender-specific data collection across EU Member States should be encouraged. 

 12. Horizontal Integration of Sex and Gender Sex and gender integration into research must be improved.  In a just society, women and men must have equal opportunity to benefit from research.  Over the years, scientific knowledge has increasingly demonstrated that some treatments affect men and women differently. Sex and gender should be integrated into research funding streams.  Applications for funding should be required to include information on sex and gender considerations in research and in health technology assessments.  The inclusion of sex and gender specific disaggregated data should be included in all future EU research programmes as criteria for funding and referenced in the guide for applicants, application forms, and guide for evaluators. The future FP9 Research Programme should include funding for training on sex and gender for consortia who submit proposals.

13. Funding Sex and Gender Health Research Sex and gender is a key determinant of health.  Explicit research on sex and gender in health should be funded at European level.  A sex and gender balance must be promoted, right from the start, throughout all stages of research, including integration into the training and education of health care professionals.  Translating the evidence from sex and gender research into practice will lead to more targeted, effective opportunities for prevention, treatment and care.  Research needs to explore how women and men experience health and health care from a multidimensional perspective across the lifespan.  Sex and gender-based analysis (SGBA) must be systematically included in health technology assessment (HTA).

 14. Women in Clinical Trials Women are generally under-represented in clinical trials.  Women make up the largest proportion of the older population and are the heaviest users of medicines. Yet, women have a 1.5 to 1.7 times greater risk of developing adverse drug reactions compared to men as women as they are not sufficiently represented in clinical trials.vi  The New Clinical Trials Regulation is a major step forward in increasing clinical trial data transparency. However, the continued under representation of women in clinical trials needs to be urgently tackled, and the regulation must be enforced.  Research must explore the existing barriers for the recruitment and retention of women and older people in clinical trials and to develop a robust methodology for subgroup analysis.  Ethics Committees should develop guidelines based on CIOMS revised guidelines that require the inclusion of women in clinical research.


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