DECENTRALISED CLINICAL TRIALS AND THE FUTURE


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


Socioeconomic factors mean women tend to be harder to recruit for clinical trials. But decentralised studies help ease barriers to participation, report Kezia Parkins and Andrew Hillman.


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 only exacerbated. “[Women] have that double burden of working and childcare and caring for older people,” observes Fiona Maini, principal of global compliance and strategy at Medidata


90 | Outsourcing in Clinical Trials Handbook


Solutions. She believes these factors can make  where DCTs [decentralised clinical trials] help.” Positive trends in harnessing decentralisation techniques in women’s health trials have been seen over the past decade. In fact, there was a peak in uptake more recently, 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


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