Global effort to include pregnant women in drug trials

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By Olivia Bowthorpe

Pregnant women are to be included in clinical drug trials under a major initiative by the World Health Organisation.

The aim is to improve the evidence base on the safety of medicines during pregnancy, reducing risk and uncertainty. Currently, more than 90% of medicines have not been tested in pregnant women.

Pregnant women have historically been excluded from drug trials due to safety concerns, with fears heightened following the Thalidomide scandal of the 1950s and 1960s. It means when prescribing to mothers-to-be, doctors often have to warn that the medicine has never been tested in pregnant women.

WHO established a global Task Force to tackle this long-standing issue following an analysis by the Global Observatory on Health Research and Development which found that only 4% of clinical trials over the past decade were open to pregnant women.

"Many pregnant and breastfeeding women are left without treatment options or take prescription medicines off-label, without adequate data to inform safe use," the WHO warns.