"Clinical research shouldn't just be safe, it should also be fair"

Why is it important to take account of sex and gender in clinical research?

Clinical research involving therapeutic products is designed to yield findings that can be transferred to as many people as possible who may subsequently receive the product being investigated. If certain groups are not represented, diagnostics, medicines and treatments might be less accurate, less safe, less effective or just riskier for them – not only because of the biological differences between men and women, but also because of gender diversity and social considerations. As a result, there is also a lack of important data on medicine interactions in children, the elderly and people with certain pre-existing conditions, for example.

What has specifically changed in recent years?

There is a growing awareness of the need for study design to take account of biological and social considerations. For example, the Swiss Human Research Act requires studies to take account of sex, age and other factors. If a relevant group is excluded, there must be good reasons for doing so. Clinical research has to find a balance between protecting certain groups and the need to develop suitable investigations and therapies for them: It shouldn't just be safe, it should also be fair.

"Clinical research should deliver findings that can be transferred to as many affected people as possible".

Is this shift reflected in current projects?

Yes, and not just in medicinal product trials, but also in research that involves analysing large volumes of existing data and biological samples. A growing number of algorithms based on artificial intelligence (AI) is being developed, for example. Having a non-diverse data pool could distort the results. A diagnostic AI algorithm trained primarily on data from men could work less effectively or even not work at all in women.

swissethics is therefore committed to ensuring that sex and gender are included in all areas of clinical research, as this is the only way of adapting medical interventions or developing innovations so they are individually suitable, safe and effective for their intended target group (often patients).

Should every study include sex and gender?

Not necessarily, but researchers should set out the reasons why sex and gender are relevant – or not – during the design phase. swissethics supports them by providing a specific checklist that helps them factor these considerations in at an early stage.