Accelerating inclusion in innovation: Gender diversity in clinical research

Clinical research continues to struggle with a lack of representation within trial populations, and gender diversity in clinical trials remains a critical issue.

The theme for this year’s International Women’s Day campaign was ‘Inspire Inclusion’, a topic that is appropriate when discussing the issue of gender diversity in clinical trials. While we have come a long way in making trials more diverse and ensuring that women are included in trial populations, more needs to be done to champion diverse patient pools to ultimately ensure that the efficacy and safety of new treatments have been tested on a representative sample of real-world patient populations.

The path to greater representation and better clinical trial data

Despite representing almost exactly 50% of the global population, women have historically been under-represented in clinical studies. It was only in 1987 that the National Institute of Health (NIH) published a policy encouraging trial organisers and researchers to include women in clinical trials. A study conducted on female enrolment by burden of disease in US clinical trials between 2000 and 2020 found that oncology (43% of participants) and nephrology (42% of participants) clinical trials had some of the lowest female representation, relative to corresponding disability-adjusted-life-years.

It is widely recognised that treatments can impact patients in different ways depending on a variety of factors, including gender, race, and age, as the drugs are metabolised differently. Treatments can therefore have varying safety and efficacy results in female patients compared to male patients. As a result, measuring a treatment’s efficacy or safety on one gender does not provide a representative picture and risks ignoring important insights that may be gained from a more representative trial.

Although the gender balance in clinical research has improved in recent years, bias still exists within clinical trial processes. The life sciences industry is focused on encouraging greater diversity within trial populations to close this gap. This includes the introduction of innovative new technologies in the drug development lifecycle, as well as new regulations that are starting to mandate action. The path to increasing the representation of women in trials has been challenging at points, but the progress made will significantly benefit patients.

Technology offers a solution

Prioritising patient engagement and facilitating participation in trials can play a significant role in increasing the diversity of trial populations. The increasing use of technology, including AI and decentralised clinical trial tools, such as wearable devices, can support greater diversity in trials and ease the associated burden for patients participating in trials. AI tools can determine the most suitable trial locations for finding eligible patients and help ensure a more diverse population, while wearable devices can monitor patients remotely and with greater frequency.

In practical terms, decentralising trials means that patients spend less time and money travelling to potentially distant trial sites, greatly reducing patient burden. This could also be particularly compelling for those with childcare or other caregiving responsibilities, who are crucial to creating a diverse trial, and data has shown that nearly 60% of unpaid carers in the UK are women. Decentralised trials have the ability to attract those who had previously regarded themselves as ineligible due to time and travel constraints. The era of digitalisation has the potential to revolutionise the field of clinical trials and promote a more equitable research process. The industry cannot afford to fall behind in its effort to improve patient engagement levels, as it is vital for accelerating progress in both trial diversity and research outcomes, which ultimately benefits patients.

Mandating action to drive progress

Recent progress in trial diversity has seen its integration into discussions around trial design. An increased focus on this area and more action from regulators means that this issue can no longer be ignored. For example, following initial guidance from the US FDA in April 2022, the US Congress passed the Food and Drug Omnibus Reform Act (FDORA) at the end of 2022, which mandates the submission of diversity action plans to the FDA for many clinical trials. Although the focus of the initial FDA guidance was on race and ethnicity diversity plans, the FDORA legislation broadens this to include sex and age as well. Action is starting in the UK, where regulators are also developing guidance to provide more oversight to increasing diversity in the research.

Although regulators are beginning to mandate and enforce action, it is important that the industry takes the initiative and drives progress, continuing to evaluate whether enough progress is made in efforts to expand diversity. This expanded focus on diversity is critical not only for trial participants, but for those supporting the clinical trial ecosystem, including all levels of clinical trial leadership. Diversity should not just be restricted to research; having diverse leaders throughout the drug development lifecycle is clearly associated with greater levels of diversity in patients and is an important way of ensuring that representation within trial populations remains top of the agenda.

The future of women in clinical trials

The industry has come a long way since the NIH’s policy on including women in trials was published nearly 40 years ago, while significant strides have been made in the last few years to ensure that clinical research is as inclusive as possible and that trial populations represent real-world patient populations. However, more work needs to be done to make sure that trial populations for innovative medicines that are meant to meet the needs of all patients are truly representative.

As the theme for this year’s International Women’s Day suggests, it is clear that, as an industry, we need to invest in strategies that ensure the inclusion of women in all aspects of clinical research. Investment in new technologies that support diversity for trial participants, as well as investment in infrastructure and leadership development, will ensure diversity remains at the forefront when launching clinical trials. Conducting studies with patient populations that accurately mirror real-world populations should be the standard for drug development; it is key to ensuring healthcare equity and that patients are receiving treatments that have been evaluated with the most accurate safety and efficacy data possible.