Recruiting patients is one of the most challenging aspects of conducting clinical trials. Certain socioeconomic factors, such as the disproportionate burden of childcare, make women more difficult to recruit, and in women’s health clinical trials, this challenge is only exacerbated.
“[Women] have this double burden of working, caring for children and caring for the elderly,” says Fiona Maini, Global Program Director at Medidata, adding that this can make it difficult to get to a site to participate. “This is where DCTs [decentralised clinical trials] really helps.
Positive trends in the exploitation of decentralization techniques in women’s health trials can be observed over the past decade. In fact, a spike in adoption can be seen in recent years, even before the Covid-19 pandemic – over the past two years we have seen increasing decentralization across all clinical trials.
Between 2010 and 2015, the percentage of women’s health clinical trials in high-income countries that included a decentralized element ranged between 1.4% and 3.1% each year. In recent years, decentralization has become more common in women’s health trials. For example, in 2018, one in 10 newly launched trials included a decentralized element.
Even more recently, from 2020 to the first quarter of this year, more than 8% of women’s health trials in high-income countries include a decentralized element, ranking women’s health seventh out of 22 therapeutic areas in Clinical Trials Arena exclusive DCT adoption tracking. The tracker analyzes 12 years of data based on clinical registry protocols, research articles and press releases to find trends in the adoption of decentralization approaches.
Women’s health covers a wide range of indications, including urogynecology, women’s sexual and reproductive health, osteoporosis and menopause.
Due to gendered and entrenched belief systems, many women’s health indications are considered taboo subjects, which means some women may still feel uncomfortable discussing certain health issues, especially with their doctor, says Matty Culbreth-Notaro, CEO of ObvioHealth. This can make it difficult to recruit into women’s health trials.
Clinical Trials Arena explores trends in the decentralization of women’s health trials and some of the ways in which decentralized techniques help overcome enrollment challenges.
Positive Trends of DCT in Women’s Health Trials
With the United States being the epicenter of women’s health studies, one in 10 women’s health studies in the country over the past decade have included decentralization, according to GlobalData’s Clinical Trials Database. GlobalData is the parent company of Clinical Trials Arena.
Since the start of 2018, 16% of women’s health trials with sites in the United States have included a decentralized approach. Additionally, during this period, US women’s health trials used ePRO/eCOA/eDiary and digital data collection in a higher proportion of trials than any other therapeutic area.
Vasomotor symptoms of menopause, commonly referred to as hot flashes, are one of the indications for women’s health with the highest rate of decentralization, with 12% of global trials involving a DCT approach since 2010. This is followed by the endometriosis (7.6%), with female contraception (1.4%) noticeably low in comparison.
Due to the added stress of the pandemic and the fact that women’s busy lifestyles make them more difficult to recruit, US-based FemTech Renovia used ObvioHealth’s DCT platform to collect patient data in this that she claims to be the world. first fully virtual Urogynecology trial. The trial evaluated Renovia’s Leva Pelvic Health System for female incontinence.
Some tend to think that some of the technologies involved in DCTs will present a problem for women, especially older women, Culbreth-Notaro notes. “People just consider men to be more tech-savvy.” But in ObvioHealth’s experience, the Virtual Research Organization (VRO) found that compliance is very high, with older women being the most compliant.
eDiary: A mainstay of women’s health trials
Electronic diaries appear to be the decentralized gold standard in women’s health clinical trials. Of the 46 ongoing Phase I-III women’s health trials involving a DCT element, the eDiaries are part of 16 studies. Telemedicine is the second most used DCT element with 12 uses in active trials.
The positive trend of electronic diary use in women’s health trials dates back to the early years of DCT. Between 2010 and 2016, more than half of all decentralized women’s health trials involved electronic diary approaches.
As the use of decentralization has grown, electronic diaries have become even more common, with at least six newly launched women’s health trials exploiting them every year since 2017, according to our analysis.
AbbVie and Myovant Sciences, for example, have both used electronic diaries in more than half of their women’s health trials over the past decade. Much of AbbVie’s women’s health research has focused on endometriosis.
Privacy is a key reason for eDiary’s high adoption
The unobtrusive nature and convenience of eDiaries make them ideal for collecting sensitive information in women’s health trials where many pain or symptom reports are needed, says Sheila Rocchio, director of marketing for eClinical Solutions.
As an example, Rocchio says even post-menopausal women having up to 50 hot flashes a day complied with a trial with eDiaries, recording every incidence. The alternative is to record high volumes and often sensitive information on paper, which can pose privacy issues within the household, she adds.
Research also shows that electronic journals lead to higher reporting among participants due to confidentialitysays Rocchio, citing trials that measured levels of arousal and satisfaction after sexual encounters in a study of female sexual dysfunction.
She explains that electronic diaries were imperative in these trials: “A lot more data was reported electronically because it was private.” If patients had to see their doctor to discuss every sexual encounter, they would not have collected the same quality data, she adds.
Additionally, eDiaries can curb “parking lot syndrome,” a well-known phenomenon in patient-reported outcomes. This refers to patients completing diaries and questionnaires shortly before a visit when they should have been completed daily or when specific symptoms occur.
With eDiaries, questionnaires are deployed when they are supposed to be completed and notifications can be sent, Culbreth-Notaro explains. “Capturing this data in real time without recall bias is much more accurate.”
Social media: a recruiting channel for women’s health
DCTs are designed to help break down barriers to access, which can allow women to participate in clinical trials from home without too much disruption to their daily lives.
Yet another obstacle is the general lack of awareness that these trials are taking place, Maini says. And this is where social media could potentially help with recruiting. “Now there are so many more platforms and methods to communicate and a lot of things that talk about women’s health,” she adds.
Culbreth-Notaro says that for an indication like incontinence that many women find it embarrassing to discuss with their doctor, being able to advertise an all-virtual trial via social media dramatically accelerated the time to recruit to 3.5 months and reduces recruitment costs.
ObvioHealth studied the online search and purchase behaviors of women browsing the web in search of products or solutions for pelvic floor disorders. “Then we placed our creative ads in front of these women via social media like Instagram, Twitter and Facebook,” Culbreth-Notaro adds.
The decentralized trial design proved attractive to women with incontinence because they could participate privately and discreetly from home, she says. Clinical Trials Arena previously pointed out the benefits of social media recruiting, and potential blind spots for sponsors.
While positive trends can be seen in the decentralization of women’s health trials, there is room for growth. This can be supported by new technological advances and by stakeholders becoming accustomed to decentralization. “DCTs are becoming more prevalent and it’s our job to educate the world about what this model brings,” says Culbreth-Notaro. “Then we’ll see more DCT trials in women’s health.”