The Importance of Gender Diversity in Clinical Trials

Did you know that cardiovascular disease is the leading cause of death among US women? Symptoms and risk factors differ significantly between male and female sufferers of the disease, meaning that certain drugs are more effective for women than for men.

It is surprising, then, to realise that only one-third of cardiovascular clinical trial subjects in the USA are women - and only 31% of clinical trials for cardiovascular treatments report results by sex.

Recruiting clinical trial participants is always a challenging process, with compliance, budgeting and incentivisation all coming into play. However, it is only recently that researchers have started to query the underrepresentation of women and minorities in clinical trials.

By a clinical trial’s very nature, its participants must be representative of those who will require the resulting treatment. Disregarding diversity in clinical trial recruitment could be closing the door to whole new ways of understanding chronic illnesses and treating them effectively in sufferers of all genders and racial backgrounds.

Why do we need diversity?

Often in clinical trials, researchers fail to enroll adequate numbers of women or, when they do, neglect to report data by sex. As every cell in our bodies has a genetic code relating to sex, this error in analysis prevents identification of important differences that could change the way we look at treatment.

For example, two-thirds of the 5.1 million people worldwide who suffer from Alzheimer’s are women - and women have almost twice as much risk of developing the disease as men do. Until recently, researchers assumed that this correlation was due to women having a longer lifespan. However, recent discoveries from female-centric studies suggest that hormonal and genetic differences in women could have a crucial part to play.

Another example of this is in anxiety and depression studies. Due to major endocrine changes throughout a woman’s life, particularly during puberty, pregnancy and menopause, women have an increased risk of depression. Despite this, fewer than 45% of animal studies on anxiety and depression use female lab animals.

The immediate risk is that these studies will result in a prevalence of treatments that are less effective for women than for women than for men - or that have more concerning side-effects for women.

Perhaps more concerningly, however, is the idea that the next wave of medical research will be informed by only male-centric trials, making it less and less likely that the significant individual differences caused by gender will be taken into account.

While in some cases gender is seen as a confounding variable that could skew results, resulting in a number of male-only trials, more often it is simply disregarded altogether. Instead, we need to move toward a new paradigm in which gender is taken into account from the very beginning of the clinical trial design process.

Why are fewer women enrolling in studies?

Trial design isn’t the only barrier to involving women in clinical trials, however. In many cases, women are simply not responding to recruitment material, or are dropping out of trials early.

Researchers looking into gender diversity in clinical studies have cited various reasons given by women as to why they don’t enroll in relevant trials. These include lack of incentive to seek alternative therapies, lack of transportation and childcare, mistrust of medical systems, and fear of fetal exposure or risk of infertility.

The root of many of these concerns is one common to all clinical studies - a need for patient centricity at all stages of the trial process. As many women will be working to maintain a career and a family life alongside coping with a chronic illness, their motivation to enroll in the study must significantly outweigh any inconvenience that participation entails.

What is being done to address this?

The FDA is working to address diversity issues in clinical trials with a focus on transparency. By making high-quality demographic data available to the public, the association will not only increase awareness of gender differences in trials and treatments, but ensure that future trials take sex and gender into account.

So far, they have put regulations, guidance, professional training, workshops and outreach into place, in accordance with the FDASIA 907 Action Plan.

Earlier on in the year, the FDA launched their Diverse Women in Clinical Trials program to raise awareness of clinical trial participation by women of all ages, ethnicities and gender identities, as well as those with various chronic health conditions and disabilities.

Working through social media, the initiative is working to take the FDA’s message directly to women. By starting this conversation, they hope to help potential participants feel more comfortable with the concept of clinical trials and more open to involvement if asked to join.

As well as this, the FDA have been working with their sister organisation at National Institutes of Health (NIH) to provide research toolkits for recruitment and retention. There is also a series of four online courses available for pharmacists, physicians and nurses, explaining how to design diverse trials and recruit a wider range of participants. These courses are incentivised with up to 24 continuing education credits.

What can you do to recruit diverse participants?

While the FDA’s plans hold a hope for more diversity in clinical trials, it’s not all good news. In 2015, the NIH halved funding to its grant for training young scientists in sex and gender diverse research. This makes creating a culture of diverse clinical trials more up to individual CROs than ever.

Change starts at the heart of the clinical trial process, so when it comes to designing a trial, ask yourselves what value your study can gain by measuring sex and gender differences. This may lead to something as simple as actively recruiting equal numbers of male and female participants, or as complex as designing the trial around these differences.

When it comes to recruitment, transparency is key. It is also important to allow extra time to review a study’s risks and benefits with female subjects, particularly if there are any gender-specific issues involved in the study. In particular, discussing pregnancy, contraception and sexual activity up-front may help to put female participants’ minds at ease.

Offer women all available information regarding potential risk of fetal exposure or infertility and give them the opportunity to discuss these issues further before signing informed consent. If you can, explain how the trial has been designed to reduce these risks - for example, by offering access to reliable contraception, or by administering treatment during or immediately after a woman’s menstrual period, you can put her mind at ease about avoiding pregnancy during the trial.

Perhaps one of the most important hurdles to jump is changing the way women view clinical trials. Ensure that you’re offering outstanding patient services to make women’s lives easier while they do their part.

By demonstrating to potential female participants that transport, child care and expenses will be reliably taken care of, you can relieve them of some of that burden, and begin to build a valuable and trusting relationship with them.

To learn more about increasing recruitment and boosting retention with custom-designed patient services, get in touch today. How do you appeal to female clinical trial participants? Let us know via LinkedIn.