Funding success for project to improve sex and gender inclusivity in medical research

Young woman about to receive a vaccine. Credit: SELF magazine

The project is being led by the George Institute for Global Health (TGI) UK and Imperial College London, who have been awarded funding of £250,000 from Wellcome.

Currently there are no policies in place that require researchers to consider the sex and gender of the people who participate in research trials in the UK. This means that studies are not required to report results about sex or gender differences, and very often do not report these findings. Therefore, both the public and healthcare providers are denied potentially crucial findings about women, men, trans and non-binary people which could influence the medical care they receive.

The MESSAGE (Medical Science Sex and Gender Equity) project will work together with members of the public, other researchers, and funding and drug regulatory bodies, to develop best practice recommendations and a sex and gender policy framework to improve gendered health outcomes in the UK. This policy framework will be supported by educational and training materials to guide the implementation of the project’s recommendations.

Professor Chloe Orkin, said: “As a researcher who works to develop new drugs, I know about cases where drugs have had to be withdrawn from the market after women turned out to be worse affected by side effects than men. This arose because studies were not designed to report results in this way and there was no policy to encourage or reward this. This project will ensure that future studies are designed and analysed in a way that is safe for everyone. By engaging with the public as well as academics, MESSAGE aims to protect women and non-binary people through research and not from research.”

Dr Kate Womersley, Honorary Research Associate at The George Institute and NHS doctor in Psychiatry, practising in Edinburgh, who co-leads the project, said: “The design, implementation, and impact of biomedical research in the UK is limited because diversity – of sex, gender, race, ethnicity, age, socio-economic status – is not adequately accounted for in research design. MESSAGE will be a big step forward for sex and gender equity.”

MESSAGE builds on work conducted by Womersley and colleagues in 2020/21. Their work found that none of the 17 largest UK medical research funders (each with budgets larger than £5 million annually), or any of the UK’s major regulators (such as The Medicines and Healthcare products Regulatory Agency), has policies in place to ensure that sex and gender are appropriately addressed at the point at which projects are funded. This means researchers are not encouraged to disaggregate their data according to sex or gender, and results often have a male bias. The UK falls far behind other countries. In Canada, the US and Europe, sex and gender inclusion policies are standard.

Professor Robyn Norton, Acting Executive Director of The George Institute, UK, said: “This project sets out to improve health equity for all people in the UK. Given that the UK currently has no medical research policies to address sex and gender within a wider network of diversity, steps must be taken to encourage funders and regulators to extend their diversity agendas and commit to change. We intend to take the learnings from this project to address other aspects of diversity in future projects.”

Dr Lilian Hunt, Equality Diversity and Inclusion in Science and Health (EDIS) Lead at the Wellcome Trust said: “MESSAGE is inclusive in both design and practice, and will deliver the key tools needed by medical research funders in the UK to integrate sex and gender policies across their areas of influence, as well as a clear rationale for why this is important. Wellcome is committed to supporting research that drives better science and more equitable health solutions”.

Sex and gender are relevant at every stage of research – from design through to evaluation – yet sex and gender analyses are often lacking. Women are often underrepresented in medical studies, even for diseases that affect relatively more women than men. This imbalance limits the interpretation and application of research findings, which can lead to flawed diagnosis and treatment, and ultimately, poorer health outcomes.

Co-creation is at the heart of MESSAGE. An experienced advisory group will guide this process to ensure meaningful involvement of women’s groups, transgender people, health practitioners, funding regulators, and other key stakeholders.