Excluding Pregnant Women From Clinical Studies Because They're Classed As 'Vulnerable' Is 'Harmful'

Pregnant women are classified as a 'vulnerable' group.

Excluding mums-to-be from clinical studies is unfair and could be potentially harmful, researchers have said.

Pregnant women are often ruled out of participating in clinical trials because they’re classified as a “vulnerable” group, and this creates a knowledge void around the impact of drugs taken during pregnancy and “unfairly excludes” them from taking part in clinical studies, concluded researchers writing in the ‘Journal of Medical Ethics’.

“There is a desperate need to shift the paradigm to protect pregnant women through research, not just from research,” the researchers wrote.

“With the recent emergence of the Zika crisis and the rapid pace of vaccine development, we have a crucial opportunity to demonstrate what proactive and intentional inclusion of pregnant women’s interests in the research and development agenda looks like.”

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The researchers stated that of the 172 drugs approved by the US Food And Drug Administraion (FDA) between 2000 and 2010, nearly all (97%+) had an “undetermined” risk for pregnancy.

The average length of time to find out how safe drugs are in pregnancy is 27 years, they stated.

In a bid to explore to what extent pregnant women really are “vulnerable”, researchers found published evidence cited four main themes as reasons for their vulnerability: 1) informed consent; 2) susceptibility to coercion; 3) heightened risk because of lack of scientific knowledge; and 4) the vulnerability of the developing foetus.

Although informed consent could be compromised because of the need to weigh up the pros and cons not only for themselves, but also for their baby, researchers stated: “There is no immediately obvious reason to assume that pregnant women are incapacitated during pregnancy.”

“There is no immediately obvious reason to assume that pregnant women are incapacitated during pregnancy.”

- Researchers in Journal of Medical Ethics.

The idea that pregnant women would be subject to coercion because of their own and society’s desire to protect the developing foetus is “paternalistic, and not really warranted,” the researchers said.

They continued: “The vulnerability of the foetus may be an issue, primarily because there isn’t enough scientific data on the potential impact of drugs taken during pregnancy, particularly new drugs.

“But the fact the unborn child can’t speak for him/herself is no reason for vulnerability; it only means there should be a surrogate decision-maker, which is the pregnant woman.”

Therefore, the researchers added: “There is no reason to assume that the vulnerability of the foetus renders pregnant women increasingly vulnerable in comparison with ordinary research subjects.”

The researchers stated pregnant women’s vulnerability boils down to the lack of research carried out in this group, and it’s a dilemma that can only be overcome by including them in future clinical studies.

“Our study once and for all demonstrates that there is no indication that pregnant women are vulnerable because of informed consent, susceptibility to coercion, or vulnerability of the foetus,” they stated.

“The only reason why pregnant women are potentially vulnerable in clinical research is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge which might render them vulnerable as research subjects.

“Only a joint effort to promote fair inclusion by funding agencies, drug authorities, researchers, methodologists, pharmacologists, guideline committees and [research ethics committees] can successfully reduce pregnant women’s vulnerability.”

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