Accelerating Action for Gender Equality in Clinical Research

This International Women's Day, NWEH is driving change by tackling the critical issue of gender inequality in clinical research. Despite years of progress, women remain significantly underrepresented in trials, leading to disparities in healthcare outcomes. 

Claire Williams, our head of Pharmacovigilance and Regulatory Services is leading the way in raising awareness and identifying ways of closing this gap to ensure that medical research is truly inclusive. 

As part of our commitment to advancing women's health equalities, Claire will be attending the FemHealth Forum in London on the 11th March, and will be participating in a panel discussion on the 18th March in Manchester for the Fem Health Integrates event exploring why women are still underrepresented in clinical trials and how we can foster greater equality across the healthcare industry.  

In her recent article, Bridging the Gender Gap in Clinical Research, Claire highlights the pressing need for inclusivity in medical studies and the steps required to address health inequalities. Here are some of the key themes that the paper addresses:  

Women face unique health challenges influenced by biological, societal, and research-based disparities. These factors contribute to differences in drug metabolism. Women process medications differently, leading to incorrect dosing and higher risks of adverse reactions.  

The Gender Gap in Scientific Research - with the imbalance starting at the earliest stages of medical research. Male-centric preclinical research often favours male cells and animals, shaping a medical knowledge base that overlooks female physiology. Due to research biases, women are 50-75% more likely to experience adverse drug reactions than men. 

Why Does This Gap Exist? Historical and societal factors have led to the underrepresentation of women in research, such as outdated regulations excluding women of childbearing age from trials, leaving a legacy of exclusion and fear of pregnancy-related risks that makes sponsors hesitant. Biological differences, such as female metabolism and hormonal variations are rarely accounted for, and practical barriers around caregiving roles make it difficult for traditional methods of study participation.   

How We Can Bridge the Gap? Significant efforts are underway to create a more inclusive research landscape. The UK’s HRA and MHRA are pushing for greater diversity in research participation.  

Raising awareness and empowering women to participate in research will help create systemic change. We must take bold steps to drive gender equality in medical research, such as:  

• Prioritising inclusivity 

• Flexible study designs  

• Data-driven decision-making  

• Advocacy and education 

Join Us in Accelerating Action 

Claire Williams is now Chair of the Central Research Ethics Committee in Greater Manchester, working closely with the HRA and the MHRA to drive change. Claire is also exploring the development of a Women’s Health Registry.  This initiative is a centralised, pre-consented database of female participants that streamlines recruitment, by leveraging electronic health records (EHRs), supporting sex-specific research, and enhancing trial inclusivity and diversity. 

Our expert team at NWEH can support sponsors to develop innovative trial designs and focus on decentralised trials and real-world data applications that can encourage broader female participation.  

Instead of waiting for regulations to enforce inclusivity, NWEH are actively developing our platforms, FARSITE and ConneXon, to enable trial sponsors to deliver studies with more representative datasets, including deprivation scores and industry leading safety reporting functionality. These advancements will help ensure diverse participation in clinical trials, leading to better, more equitable healthcare outcomes for all.  

This International Women’s Day let’s push forward together, accelerating action, breaking barriers, and ensuring a healthier, more inclusive future.