Making Clinical Trials Family Friendly

While it might seem like a no-brainer that women would be proportionally represented in clinical trials for treatments that they’ll ultimately use, this is not always a given. For instance, women make up 60 percent of the mental health patient population, yet account for just 42 percent of trial participants.

In the past, gender parity in trials simply wasn’t a priority, but it is very different today. It’s now understood that the only way to ensure the safety and efficacy of treatments is by testing them on the populations that will use them. In the case of women, it's widely accepted that they process and metabolize medications differently than men. For this and other reasons, the industry is striving to achieve proportionate representation of women in trials. 

In my experience, women consistently express their willingness and interest in participating in clinical research. However, when it comes to recruiting and retaining women for trials, there can be barriers. For example, many women disproportionately bear the burden of childcare responsibilities, in addition to having a full time job. These women can have difficulty carving out even a small amount of time for themselves, so adding a clinical trial to their already crammed schedules might not seem feasible – especially if they need to find childcare before attending regular appointments. 

An understanding of the limiting factors that hinder women from taking part in clinical trials is key to designing appropriate trials and recruitment tactics.

If a trial requires participants to attend medical appointments between the hours of 9am and 5pm, women with childcare responsibilities may find it difficult to participate – and even if they were to enroll in the trial, getting them to consistently maintain those appointments for the trial duration can be difficult.

Trial sponsors can significantly reduce issues related to women’s schedules by figuring out how to accommodate them. One way of doing this is allowing participants to schedule appointments in the evenings or over the weekends. Additionally, offering telehealth check-ins, when appropriate, can give participants a way to share updates without the travel time. Another option is allowing participants to have basic procedures, such as getting their blood drawn at local pharmacies, rather than requiring them to travel to the trial site. These methods have proven to improve recruitment and retention rates across all populations – but it is especially essential to consider when recruiting women.

Once a trial has been designed with these nuances in mind, make sure the trial recruitment messaging reflects them. Letting women (and other trial participants) know about scheduling conveniences and other factors that take lifestyles into account can quickly offset related concerns. 

I’ve also found that creating an environment that caters to families at trial sites can help increase retention. For example, offering coloring books or a puzzle in a waiting room is an inexpensive way to make participants feel as if their family is welcome. Even if children choose not to interact with the materials, clinical trial participants have told me that it made them feel like their family was welcome at the trial site. This can help alleviate the childcare burden and increase retention.

Additionally, across all populations, recruiting participants close to trial sites has proven to cut down on long travel times that lead to participants dropping out. Especially in the case of women caring for children, traveling over an hour to a trial site, even if it’s infrequent, can be a challenge since they either need to bring their child with them or arrange childcare. 

These types of approaches have led to positive results in our own recruitment of women in trials. For instance, when recruiting for a trial for cardiovascular disease, which is more prominent in men but leads to a higher mortality in women, we were able to achieve 53 percent female randomizations. Additionally, for an alopecia trial (more prominent in women) we were able to achieve 63 percent female randomizations using tactics specifically designed to accommodate women.

Increasing the number of women who participate in trials now will have long-standing effects on the future of women's health. After all, 50 years ago, a breast cancer diagnosis was met with limited treatment options. Now, thanks to 40 years of research and clinical trials that almost exclusively recruited women, there are new ways to detect breast cancer earlier and more treatment options to combat it from there. As a result, there was a 44 percent decline in breast cancer-related deaths between 1989 and 2022.

While there is no silver bullet, the trials that successfully recruit and retain women the entire trial duration are usually those that are genuinely committed to fostering an inclusive and flexible environment at every trial touchpoint.