DIVERSITY, EQUALITY & INCLUSION


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 used ePRO/eCOA/eDiary and digital data collection in a higher share of trials than any other therapy area.


Hight rates of decentralisation: a challenge for recruitment 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 enovia employed the T platform of ObvioHealth, a virtual research organisation (VRO), to collect patient data in what it claims is the worlds first fllyvirtal urogynaecology trial. The trial evaluated Renovia’s Leva Pelvic Health System for female incontinence. Some people tend to think that some of


the technology involved in DCTs will present a problem for women, especially for older women, notes Culbreth-Notaro, as “people just consider men to be more tech-savvy”. But, from ObvioHealth’s experience, compliance is very high, with older women being the most compliant.


The eDiary: A mainstay in women’s health trials


The eDiary appears to be the go-to decentralised element in women’s health clinical trials. Among the 46 ongoing Phase I to Phase III women’s health trials involving a DCT element, eDiaries are being used in 16. 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.


Credit: Shutterstock.com 60 | Outsourcing In Clinical Trials


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