Integrating sex and gender differences in health research

The EU-funded project GenderBasic has developed a number of recommendations for the improved integration of sex and gender differences in health-related research. Scientists must be aware of these differences at all stages of their studies, from the research content itself to the processes and methods employed in clinical trials, says project coordinator, Dr Ineke Klinge of the University of Maastricht in the Netherlands.

On research content, the GenderBasic partners suggest taking into account biological sex differences, as well as socio-economic gender aspects in health research. For instance, in the neurosciences, the areas of cognition and mood enhancement would benefit from considering differences between men and women, says Dr Klinge, noting that the same is true for the study of human performance and human health.

Looking at processes and methods in animal clinical trials, Dr Klinge suggests that research projects should be obliged to test drugs on male as well as female animals where appropriate, although this would make the study larger and thus possibly increase the number of animals used in tests. The researchers would then have to record age, weight, reproductive status and the ovarian cycle phase as accurately as possible and disclose the sex of the animal. Their reports should also take into account the impact of sex and gender differences on all aspects of the experiment.

In human clinical trials and health research, studies should involve men as well as appropriate numbers of women as subjects, according to the GenderBasic recommendations. Currently, the percentage of female participants amounts to only 30% in most trials, while the target should be 50% in order to achieve appropriate representation of both sexes.

Reportedly, a number of diseases affect men and women differently. For example, the inflammatory and chronic airway disease, asthma, occurs more frequently in boys before puberty, while girls are more likely to suffer from the disease after puberty. Due to the complexity of the disease, no straightforward single mechanism can explain gender differences found in asthma.

Meanwhile osteoporosis, a disease of the bone that increases the risk of fracture, is considered to affect mainly women after their menopause. The drugs that are developed for osteoporosis are therefore usually modelled on female patients, however these also prescribed to the smaller number of male patients.

However, osteoporosis is clearly an exception that proves the rule. According to Joana Namorado of the European Commission's Directorate for Health within the Directorate General for Research, her own experience as a clinician has shown that even if minority groups such as women become a majority group for a disease, they are not of interest to the pharmaceutical industry. Most scientists would not listen to gender arguments as gender is a rather fuzzy concept, she says, noting that the concept of sex is far more tangible. However, "drugs are still produced for rich white males," believes Dr Namorado. "What we need is a personalised medicine that has to take care of gender and of sex."

The GenderBasic project officially ended in autumn 2007 and received just over €200,000 under the Sixth Framework Programme (FP6). Some of its results in the form of a number of review articles commissioned from international experts were published in a supplement of the Gender Medicine Journal entitled "Bringing gender expertise to biomedical and health-related research".

For further information, please visit:
http://www.genderbasic.nl/

Copyright ©European Communities, 2008
Neither the Office for Official Publications of the European Communities, nor any person acting on its behalf, is responsible for the use, which might be made of the attached information. The attached information is drawn from the Community R&D Information Service (CORDIS). The CORDIS services are carried on the CORDIS Host in Luxembourg - http://cordis.europa.eu. Access to CORDIS is currently available free-of-charge.

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