Clinical trials are the backbone of medical innovation enhancing the safety, efficacy, and accessibility of treatments. But many women face challenges for participating in clinical trials due to various barriers that hinder them from enrolling in clinical studies. Although the growing recognition around gender health equity is gaining momentum in healthcare cultural norms and financial barriers obstruct women from participating in clinical studies.   

Women account for less than 30% of participants in early-phase industry-sponsored trials, and their representation in studies on cardiovascular disease, cancer, and psychiatric disorders remains disproportionately low compared to their actual disease burden. 

Why are women still underrepresented in clinical trials?    

In early 1990’s women were historically and effectively excluded from clinical trials in the past due to scientific, ethical, and political factors. Additionally, it is well-established that the sex-based biological differences such as hormonal fluctuations, body composition, and metabolic pathways significantly influence pharmacokinetics and pharmacodynamics, making it inappropriate to generalize male data to female populations. The historical reasons for this exclusion, there was a misperception that men’s responses to drugs could simply apply to women. However, regulations have evolved to include them and ultimately reach a more realistic population sample in trials. In the recent years women are more represented but still not to the level we should be aiming for.  

 We’ve since seen a lot of research that demonstrated that women metabolize medication differently. We have reached a point where there is greater recognition of the problem, but it takes time to address it. 

Despite of meeting eligibility criteria, women face systemic barriers including family caregiving responsibilities.  Many clinical studies require women of childbearing age to use long-acting contraceptives can be additional hurdle. The requirement for women of childbearing age to use long-acting contraceptives in many clinical studies can pose an added barrier to participation. Also, many trials do not support compensation for lost wages, travel, expenses or childcare.   

Takeaways 

• This should be taken as a significant issue if a balanced sex representation is not ensured in clinical studies. If women are underrepresented, the data may falsely suggest a drug is universally effective. Moreover, excluding or underrepresenting women undermines the ethical principle of equity in research. 

• Balanced representation can uncover sex-specific benefits or risks, paving the way for personalized medicine. 

• Additionally, data analysis by sex should become a norm to properly characterize drugs’ safety and efficacy profiles in women. 

• In clinical studies, statistical analyses should ensure balanced and rational representation of genders to accurately reflect the broader population 

•  Reaching out to female-focused organizations and social media groups can facilitate awareness of clinical trials and improve recruitment. 

• Sponsors should incorporate females’ voices in designing clinical trials to facilitate their participation. 

• Sponsors should collaborate with trial sites to offer flexible options like evening, weekend, or remote visits via telehealth solutions when it’s possible for improving participation. 

Further reads 

Nature: Women are poorly represented in clinical trials 

Clinical Trials Arena: Underrepresentation of women in early-stage trials 

Trials Journal: Meta-analysis on gender gaps in RCTs 

JAMA: Gender gap in trial leadership 

BMJ: Practical steps to prioritize women’s health 

UChicago Medicine: Barriers to breast cancer trial participation 

Medical Research Foundation: Closing the sex and gender gap 

Systematic Reviews: Strategies for enhancing representation 

Kinneir Dufort: Closing the gender gap in clinical trials