A group of women in front of a wall of graffiti.

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

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

By Kezia Parkins, Clinical Trials Arena

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. Read more …