The secret to enrolling more women in clinical research

Women are still underrepresented in clinical research. One analysis found that, though 50.8% of the US population is female, only 41.2% of US research participants are female. The gender disparity illustrated by this statistic worsens when specific therapeutic areas are explored. The same analysis reported that 41% of oncology research participants are female, even though 51% of people with cancer are women, and 42% of participants in psychiatric drug trials are female, although 60% of people with psychiatric disorders are women.¹

We all know that different people – including different genders – respond to medicines, diagnostics, therapeutics, and other products in unique ways. To truly test the safety and efficacy of a new product, it must be tested on an adequate representation of the entire intended use population – again, including different genders. Therefore, we must increase female participation in clinical research.

Ease is the key to access

According to the American Psychological Association, women are more likely than men to report having a lot of stress, meaning they self-reported an 8-10 on a 10-point stress scale.² A survey of American women aged 18 and older found that 55% of respondents felt they are too busy, and the average respondent wished they had an extra 82 minutes in their day to complete the necessary tasks.³ The over-extended, frazzled female trope is ubiquitous because women often wear numerous hats: mother, homemaker, care provider, spouse, employee, and many, many more. It makes sense that women are less inclined to participate in clinical research because they have no desire to add to their brimming to-do lists.

That’s why the solution to enrolling more women in clinical trials is simplicity. When clinical trial participation is easy and hassle-free, more women will enrol. We can make participation simple for women by utilising virtual clinical trial technology and incorporating real-world healthcare experiences into trial design.

Virtual trial models bring research to women

Women make up more than 60% of all telehealth patients and are the majority in every telehealth use group.⁴ It’s safe to assume that women prefer telehealth over in-person care because it’s easier. Without travelling to and waiting around in doctor’s offices, planning for childcare, or missing work, telehealth is just more convenient. The same can be said for decentralised or virtual clinical trials – if women can complete the trial protocol without having to rearrange their entire schedules to attend in-person visits, it makes sense that they’d be more likely to participate.

Increase female participation by uniting healthcare and research

Of course, there are instances in which in-person visits are essential. Such in-person study visits are traditionally conducted by large research centres or expansive hospitals. While these experienced sites do quality work, they are so far removed from patients’ everyday healthcare experiences that they can be prohibitive to participation. Many would-be participants must travel long distances to make in-person visits at such centres, take time off work, and rearrange their schedules. Furthermore, would-be participants might be nervous or afraid to put their health in the hands of providers they’ve never or rarely met. Sadly, due to a long history of underrepresentation, such fear is especially true for women. Therefore, to make research participation easier and thus more likely for women, we must integrate real-world healthcare into trial design by engaging female patients through their trusted providers.

Rather than following the traditional enrolment method of selecting research sites and then searching for patients, we should use electronic health record (EHR) data to identify patients that fit the inclusion/exclusion criteria, connect with the healthcare facilities they already use, invite those facilities to serve as sites, and then engage with the identified patients through their trusted providers. Enabling women to participate in a trial with their known physician reduces the burden of participation because they won’t have to travel long distances, make schedule changes, take time off work, or face the fear that comes with walking into an intimidating research centre and putting their health in the hands of an unknown provider. In other words, it makes participation simpler.

Healthcare, research, and diverse female participation

We cannot discuss the importance of increasing female participation in research without including the essentiality of increasing the participation of women in traditionally underrepresented groups. Fortunately, bridging the gap between healthcare and research helps increase the participation of all women, including those of colour.

Enabling female patients to visit their physician or a local practitioner for a clinical study reduces the cost and burden of participation. But perhaps more importantly, it supports a more familiar trial environment and eases the medical mistrust that commonly plagues diverse patients.⁵ A female patient of colour is more likely to enrol in a clinical trial if she can go through the study process with a trusted provider who looks like her, understands her culture, and whom she trusts has her best interest in mind.

Data supports the use of private practices and other community research sites in boosting diverse research participation. A Tufts Center for the Study of Drug Development (CSDD) survey report compared participant diversity at academic medical centres (AMCs) and community provider sites, finding that 6.6% and 10.4% of AMC patient populations were Black and Latino, but 31.8% and 17.3% of participants at community providers were Black and Latino.⁶

The complexity of simplicity

The research industry has been travelling the same road for decades, and every passing year makes it harder to pull free from deeply ingrained processes. Simplifying trial participation for women, therefore, requires focused strategies, intentional tactics, and partnerships with organisations that offer virtual trial solutions and access to community practices. Together, we can set in motion the industry-wide shifts that will make it easier for women – and all other underrepresented groups – to participate in clinical trials.

About the Author

Dawn Sauro, chief operating officer at Elligo Health Research, has 30+ years of drug and device development experience, including working for sites, sponsors, and CROs. She has experience across a broad spectrum of therapeutic areas, but her main area of expertise is in haematology and oncology. Having led several successful haematology/oncology development programmes, from First-in-Human through successful registration, she brings this expertise in delivery to help sponsors drive results.