Women’s health clinical trials: breaking down barriers through decentralisation

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atient recruitment is one of the most challenging aspects of running clinical trials. Certain socioeconomic factors, such as the disproportionate burden of childcare, make women harder to recruit and, in women’s health clinical trials, this challenge is only exacerbated.

“[Women] have that double burden of working and childcare and caring for older people,” says Medidata principal of global compliance and strategy Fiona Maini, adding that this can make getting to a site to participate difficult. “This is where DCTs [decentralised clinical trials] really help.”

Positive trends in harnessing decentralisation techniques in women’s health trials can be seen over the past decade. In fact, a peak in uptake can be seen in recent years, even predating the Covid-19 pandemic—in the past two years, we have seen increasing decentralisation across all clinical trials.

Between 2010 and 2015, the percentage of women’s health clinical trials in high-income countries that included a decentralised element varied between 1.4% and 3.1% each year. In more recent years, decentralisation has become more common in women’s health trials. For example, in 2018, one in every 10 newly initiated trials included a decentralised element.

Even more recently, from 2020 to the first quarter of this year, over 8% of women’s health trials in high-income countries include a decentralised element, ranking women’s health as seventh out of 22 therapy areas in Clinical Trials Arena’s exclusive DCT adoption tracker. The tracker analyses 12 years of data based on clinical registry protocols, research papers, and press releases to find trends in the uptake of decentralisation approaches.

Women’s health covers a broad range of indications, including urogynaecology, female sexual and reproductive health, osteoporosis, and menopause.

Due to sexist and ingrained belief systems, many women’s health indications are deemed taboo topics, which means some women may still feel uncomfortable discussing certain health issues, especially with their doctor, points out ObvioHealth chief operating officer Matty Culbreth-Notaro. This can make recruitment in women’s health trials tough.

Clinical Trials Arena explores trends in decentralising women’s health trials, and some of the ways decentralised techniques are helping overcome enrolment challenges.

With the US being an epicentre of women’s health studies, one in 10 women’s health studies in the country within the past decade has included decentralisation, according to GlobalData’s Clinical Trial Database. GlobalData is the parent company of Clinical Trials Arena.

Since the beginning of 2018, 16% of women’s health trials with sites in the US have included a decentralised approach. Further, during that period, US women’s health trials have utilised ePRO/eCOA/eDiary and digital data collection at a higher share of trials versus any other therapy area.

Vasomotor symptoms of menopause, commonly known as hot flashes, is one of the indications within women’s health with the highest rate of decentralisation, with 12% of global trials involving a DCT approach since 2010. This is followed by endometriosis (7.6%), with female contraception (1.4%) noticeably low in comparison.

Because of the added stress of the pandemic and the fact that women’s busy lifestyles make them tougher to recruit, US-based FemTech firm Renovia employed ObvioHealth’s DCT platform to collect patient data in what they claim is the world’s first fully virtual urogynaecology trial.

The trial evaluated Renovia’s Leva Pelvic Health System for female incontinence.

Some tend to think that some of the technology involved in DCTs will present a problem for women, especially for older women, Culbreth-Notaro notes. “People just consider men to be more tech-savvy.” But from ObvioHealth’s experience, the virtual research organisation (VRO) found compliance is very high, with older women being the most compliant.

eDiaries appear to be the go-to decentralised element in women’s health clinical trials. Among the 46 ongoing Phase I–III women’s health trials involving a DCT element, eDiaries are in 16 studies. Telemedicine is the second most used DCT element with 12 uses in active trials.

The positive trend of eDiary use in women’s health trials can be traced back to early years of DCT. Between 2010 and 2016, more than half of all decentralised women’s health trials involved eDiary approaches.

As the use of decentralisation has grown, eDiaries have become even more common, with at least six newly initiated trials in women’s health harnessing them each year since 2017, our analysis shows.

AbbVie and Myovant Sciences, for instance, have both used eDiaries in more than half of their women’s health trials in the past decade. A large share of AbbVie’s research in women’s health has focused on endometriosis.

The discreet nature and convenience of eDiaries make them ideal for collecting sensitive information in women’s health trials where a lot of pain or symptom reporting is needed, eClinical solutions chief marketing officer Sheila Rocchio says.

As an example, Rocchio says that even post-menopausal women having as many as 50 hot flashes a day were compliant in a trial with eDiaries, recording each incidence. The alternative is recording high volumes and often sensitive information on paper, which can open privacy issues within the household, she adds.

Research also shows that eDiaries lead to higher reporting among participants due to privacy, Rocchio says, pointing to trials that measured arousal levels and satisfaction after sexual encounters in a female sexual dysfunction study.

She explains that eDiaries were imperative in these trials: “A lot more data was reported electronically because it was private.” If patients had to visit their doctor to discuss every sexual encounter, they would not have collected the same quality data, she adds.

Further, eDiaries can curb “parking lot syndrome,” a well-known occurrence in patient-reported outcomes. This refers to patients completing diaries and questionnaires shortly before a visit, when they should have been filled in daily or when specific symptoms are manifesting.

With eDiaries, questionnaires are deployed when they are supposed to be filled, and notifications can be sent, says Culbreth-Notaro. “Capturing that data in real-time without recall bias is much more exact.”

DCTs are designed to help break down access barriers, and this can allow women to participate in clinical trials from their own homes without too much disruption to daily life.

Yet, another barrier is the lack of general awareness that these trials are happening, Maini says. And this is where social media could potentially help with recruitment. “Now there are so many more platforms and methods to communicate and lots that are talking about women's health,” she adds.

Culbreth-Notaro says that for an indication like incontinence that many women find embarrassing to discuss with their doctor, being able to advertise a fully virtual trial via social media dramatically sped up the recruitment timeline to 3.5 months, and reduced recruitment costs.

ObvioHealth studied the online search and purchasing behaviours of women scouring the web for products or solutions for pelvic floor disorder. “Then we placed our creative ads in front of those women via social media like Instagram, Twitter, and Facebook,” Culbreth-Notaro adds.

The decentralised trial design proved attractive to female incontinence sufferers as they could participate privately and discretely from their own homes, she says. Clinical Trials Arena previously reported on the advantages of social media recruitment, and potential blind spots for sponsors.

While positive trends can be observed in decentralising women’s health trials, there is room for growth. This can be supported by further technology advancement and stakeholders becoming even more accustomed to decentralisation. “DCTs are becoming more prevalent and it's our job to educate the world on what that model brings,” Culbreth-Notaro says. “Then we will see more DCT trials in women's health.”