DECENTRALISED CLINICAL TRIALS AND THE FUTURE
women’s health clinical trials in high-income countries that included a decentralised element varied between 1.4% and 3.1% each year. become more common in women’s health trials. For example, in 2018, one in every 10 newly initiated trials included a decentralised element.
quarter of 2022, over 8% of women’s health trials in high-income countries included 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 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 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.
Positive DCT trends in women’s health trials With the US at the epicentre of women’s health studies, one in 10 women’s health studies in the country within the past decade have included decentralisation, according to GlobalData’s Clinical Trial Database. 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 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
“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”
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 platform to collect patient data in what it claims Health System for female incontinence. There is a tendency to think that some of the technology involved in DCTs will present a problem for women, especially for older just consider men to be more tech-savvy,” she says. But from ObvioHealth’s experience, compliance is very high, with older women being the most compliant.
eDiary: a mainstay in women’s health trials eDiaries appear to be the go-to decentralised element in women’s health clinical trials. 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 the 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,
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