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March 28, 2022

Women’s health clinical trials: increase in studies but still many opportunities for growth

Despite an increase in the past decade, there is still room for improvement in clinical trials focused on women’s health studies.

By GlobalData Healthcare

The past ten years have seen a significant increase in the level of clinical trial activity geared towards women’s health studies. But there is still room for improvement, such as more initiations for industry-sponsored trials, as well as Europe and North America needing to host more of such investigations.

The period from January 2012 to 17 March 2022 saw a consecutive year-on-year rise in trial initiations between 2013 and 2019, with a record number of initiations observed in 2019. The greatest decline in trial initiations was seen in 2020, with the number of trials falling to a five-year low, demonstrating the impact of the Covid-19 pandemic. A further decline was seen last year, contrasting the general trend of clinical trial activity recuperating between 2020 and 2021 following the mitigation of clinical trial disruptions.

This continued drop in activity last year may be attributed to the fact that studies within this field largely occurred within hospital or clinic environments, and so the scope for a more decentralised approach would have been relatively limited. There is a lack of significant variation between decentralised trial usage in this field prior to and during the pandemic.

Infertility studies dominate women’s health clinical trials

Also in the past decade, women’s infertility studies dominated the research landscape and held 24.7% of all women’s health studies. Clinical trials investigating labour and delivery held second place at 15.3%, with ovarian disease studies in third place, accounting for 14.6% of studies. Clinical trials investigating pain narrowly outnumbered menstrual disorder studies with 12.5% and 12.3% of studies, respectively.

Despite this, the level of industry sponsorship remains relatively low overall in women’s studies at 19.6%. An increased level of industry involvement would support the development of effective therapies and practices within this field.

Asia-Pacific dominates the research space, with 36% of trials in the past decade. The Middle East and Africa hold second place with 30.5% of studies, outnumbering both Europe (17.8%) and North America (13.1%), while South and Central America hold 2.5% of studies.

Iran a key player while China becoming increasingly dominant

Observing the country-wise distribution, Iran was the leading research location overall with the highest number of trial initiations (18.8%) from 2012 to 2017. Iran’s strong research effort is driven almost universally by institutional research (98.4%) with a focus on female infertility and ovarian disorders.

China holds second place overall (15.8%), but has become increasingly dominant in recent years, with the highest number of trial initiations every year since 2018. China’s growing research dominance has coincided with an uptake in industry-sponsored trials. From 2012 to 2017, only 12.8% of studies were industry-sponsored. This figure increased to 21.8% from 2018 to 2021. China’s primary focus within the field of women’s health is infertility studies, with the growing interest in recent years being potentially attributed to falling birth rates in five consecutive years, hitting record lows last year. The US holds third place with 11.4% of studies, followed by India (9.3%) and Egypt (7.1%).

On a regional basis, Europe is significantly underrepresented, with no European countries appearing in the top five. In addition, relative to other indications, women’s health is also underrepresented in North America. Greater research efforts in these regions are required to address many inequalities within the field, especially those related to higher death rates during labour for minority populations.

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