Achieving gender parity – designing clinical trials with women in mind

By Katherine Seay

For years, women have been significantly underrepresented in clinical trials, despite making up a large portion of patients who will ultimately use the resulting treatments. This gap is particularly evident in the mental health field, where women account for 60% of the patient population but only 42% of clinical trial participants.

A large part of the problem is that gender equity in clinical research was historically not a priority. This resulted in trials predominantly enrolling males, even though the resulting treatments would be used by both males and females in the wider population. Another reason for the lack of proportionate representation of women in trials is that women have competing pressures on their schedules and lifestyles that trials have failed to cater to.

All of this is now changing as the pharmaceutical industry is aligned on the need for trial participants to mirror the populations who will ultimately use them. It is now widely understood that women and men process and metabolise medications differently, so ensuring trials meet this criterion is not only good science, it’s the only way to ensure the treatment’s safety, tolerability and effectiveness.

Despite the fact that pharma is clear on the need for and benefits of gender parity, achieving it is not as simple as knowing it.

The good news is that women want to be included and are eager to participate in research. But in order to make this a reality, sponsors need to design trials with women in mind – from initial recruitment to the end of the full trial duration. Here are a few ways this can be done effectively.

Although women may want to get involved, they may not be proactive about it, so it’s important to identify and address the issues that are potentially holding them back in recruitment efforts.

Women across different age groups often have multiple competing priorities, such as full-time jobs, family responsibilities, etc. And if they’re being considered for trials, they’re also inevitably dealing with a health condition that could affect their energy levels, day-to-day comfort, mobility and other physical factors.

As a result, many don’t go out of their way to seek out clinical trials, even if they would otherwise like to get involved. For some women, taking even small amounts of time for themselves is a luxury, so adding in a trial that would require regularly attending doctors’ appointments might seem next to impossible. And while retired women may have extra time to participate, depending on their health condition(s), they may not have the energy or assistance they would need to do so.

All of this means sponsors have to work with women to alleviate the different concerns they have. This isn’t just about saying the right thing, it’s about designing trials with the nuanced needs of the desired woman audience in mind from the start.

Rather than designing and recruiting for a trial in the hope that it generally appeals to women at large, it’s critical to consider the desired audience’s age, lifestyle and health conditions. A 40-year old mother who suffers from migraines, for instance, won’t have the same needs as a 60-year old woman going through menopause or a 75-year old with Alzheimer’s. Gaining a more thorough understanding of different women’s circumstances can help with decisions concerning the trial format, location and other factors – all of which should be reinforced in recruitment tactics to offset potential candidates’ concerns upfront.

Although not all women work full time, a majority of women between the ages of 20-65 have work responsibilities competing for their time. This age group makes up a significant portion of women who may qualify for and participate in clinical trials.

There’s also an increase in trials for conditions that affect predominantly working-aged women— such as menopause, endometriosis and menstrual migraines. As a result, more trials than ever need to enrol women that may have full time jobs.

If a trial requires weekly appointments during regular work hours, there is a very low likelihood of women enrolling in the trial and if they do enrol, there is a high chance they will drop out before the trial’s completion. This is because attending appointments during working hours while also holding a full-time job and juggling family responsibilities can be very difficult.

As a result, prioritising flexibility that allows women to schedule appointments at a time that’s convenient for them is essential. This could be allowing participants to schedule appointments at trial sites in the evenings or at weekends to accommodate their business schedules. The addition of telehealth check-ins, where appropriate, can give participants a flexible option. Additionally, allowing participants to do basic tests, such as getting their blood drawn, at a local pharmacy can help cut down on travel times and the overall time commitment required.

One barrier we often come across when recruiting and retaining women for trials is the childcare burden. In the United States, childcare costs continue to increase and this added cost can be prohibitive to some women participating in trials, especially if they need to cover childcare costs every time they visit a trial site. Additionally, if women can’t find childcare when they need to attend appointments, this can lead to them missing appointments or dropping out of the trial altogether.

To overcome the childcare burden on most women, creating an environment that’s welcoming for children is very important. Trial sites that accommodate families and understand women’s roles as the typical family caretaker tend to experience better retention.

The investment in making a trial site child-friendly doesn’t need to be expensive – offering puzzles and games in the waiting room for a trial site can be an inexpensive way to make women feel like their children are welcome. In a trial for hidradenitis suppurativa, which is most prevalent among black women, trial sites that offer these forms of child entertainment are seeing positive feedback from participants. Women note on participant surveys that they feel their children are welcome at the trial site, even if they choose not to engage with the entertainment directly.

In addition to women-specific approaches, clinical trials should preserve those tactics that have proven to boost participant recruitment and retention across populations, age groups, races, genders and other demographics.

‘Gender equity in clinical research was historically not a priority, resulting in trials predominantly enrolling men’

For instance, potential candidates’ lack of awareness of the trials that are available to them and how to get involved is one of the most common challenges standing in the way of connecting with new participant pools. Simply not knowing about trials is a huge missed opportunity for participants, who could gain valuable health and quality-of-life benefits, and for trial sponsors who need them to test their treatments.

Advertising on social media platforms to reach nuanced audiences in specific geographic locations or with specific health conditions is a proven way of bridging the awareness gap with such audiences. Here, sponsors can acutely narrow down their requirements and meet potential participants where they already spend their time.

Long travel times to trial sites is another factor that has proven to be a significant roadblock to participant recruitment and retention across all demographics.

To overcome this, targeting populations near a trial site can decrease the likelihood of participants dropping out due to travel-related complications.

Ensuring participant satisfaction and thereby, retention, through the entire trial experience ultimately comes down to their one-to-one interactions. Human care plays a critical role in this, as participants want to work with providers they trust. Some participants may not fully understand what their diagnosis or treatment plan means, for instance, so working with highly trained medical staff who can answer their questions and help them understand the nuances is essential.

Over the years, the approaches described here have led to groundbreaking results in our own recruiting of women for trials. For instance, when recruiting for a vitiligo trial, a condition that affects both genders equally, we were able to achieve 50% female representation. In addition, when it comes to alopecia, a condition more prominent in women, we were able to achieve 63% female randomisation.

The future of women’s health depends on enrolling more women in clinical trials. Over the past 40 years, research focused on women’s health – particularly in the case of breast cancer – have led to tremendous advances in early detection, treatments and survival rates. As a result of this research, there was a 44% decline in breast cancer-related deaths between 1989 and 2022. This progress highlights what’s possible when women are involved in clinical research.

Ultimately, trials that show a genuine commitment to fostering an inclusive and flexible environment at every trial touchpoint will see a boost in success.