DIVERSITY, EQUALITY & INCLUSION


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


Women tend to be harder to recruit for clinical trials due to socioeconomic factors. But decentralised study designs can help ease the barriers to participation.


P


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 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 mae it difficlt to get to a clinical trial site to participate. “This is where decentralised clinical trials (DCTs) 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. Over 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, which included a decentralised element, varied between 1.4% and 3.1% each year. In more recent years, decentralisation has become more common. For example, in 2018, one in every 10 newly initiated trials included a decentralised element. ven more recently, from  to the first


quarter of this year, more than 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 analysed 12 years of data, based on clinical registry protocols, research papers and press releases to find trends in the ptae of decentralisation approaches.


Women’s health trials among the top users of decentralisation Women’s health covers a broad range of indications, including urogynaecology, female sexual and reproductive health, osteoporosis and menopause. Due to some sexist belief systems, many


women’s health indications are deemed taboo topics, which means some women may still feel uncomfortable about discussing certain health issues, especially with their doctor, points ot bvioealth chief operating officer atty Culbreth-Notaro. This can make recruitment in womens health trials more difficlt. Clinical Trials Arena explores the trends in


decentralising women’s health trials, and some of the ways that decentralised techniques are helping to overcome enrolment challenges.


Positive DCT trends in women’s health trials With the US being an epicentre of women’s health research, one in 10 of these studies across the country within the past decade has included decentralisation, according to GlobalData’s Clinical Trial Database. GlobalData is the parent company of


Outsourcing In Clinical Trials | 59


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