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.
Identifying and addressing the issues
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.
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