Why Pregnant Women Should be Allowed to Partake in Clinical Trials

When it comes to clinical trials, pregnant women are excluded as they are considered to be vulnerable. Now, researchers have said that this exclusion is unfair, as leaving mothers-to-be out may be more harmful than helpful.

By leaving out expectant mothers there is a knowledge void that surrounds the effects of drugs taken during pregnancy. There is now a desperate need to shift the thought process from protecting women from research when pregnant, to protecting them by being able to research.

Why pregnant women are excluded from trials

Understanding the Parameters

With viruses like Zika which have recently affected pregnant woman, there is an opportunity to demonstrate how R&D in pregnant women could help others, and how clinical trials should not be discounted.

The major concern of any researcher would be the health of the unborn child. Just as the health of the patient is considered when patient recruitment services such as http://www.richmondpharmacology.com/patient-recruitment.php seek out new test subjects, so too would the health of mother and child be of foremost concern. This, however, can be taken into account, and research and trials can still take place in a controlled environment.

The major concern in this case is the vulnerability of pregnant women, their susceptibility to coercion and the vulnerability of the foetus. For many, the issue of consent arises too, as the mother has to make decisions for the foetus, and this brings in to call the rights of an unborn child too. However, the vulnerability that many pregnant woman experience comes down to lack of research, so it’s a two-fold situation. More research would reduce their vulnerability, but it may make them more vulnerable initially.

Weighing up risk and consent

Reducing Risk

The case for more research

There have been many studies conducted on pregnant women, but these have involved vitamins, supplements and other similar factors. Clinical drug trials have not been allowed generally, but there are those who are now actively pushing for this to change.

If funding agencies, researchers, methodologists, pharmacologists and guideline committees were to work together to create a fair inclusion of pregnant women, major breakthroughs may be forthcoming.

For many women there would be a willingness to take part in trials, especially if their baby’s health was already compromised and there was a chance that a new drug or treatment would be successful. For now, they are unable to.

Summary

This article argues that excluding pregnant women from clinical trials, intended to protect them, may actually cause harm by leaving a knowledge gap around how drugs affect pregnancy, highlighted by the Zika virus. It covers concerns about consent, coercion and foetal safety, and suggests that funders, researchers and pharmacologists working together could enable fairer, safer inclusion of pregnant women in future studies.

Questions this article raises

• What safeguards would be needed to include pregnant women safely in clinical trials?
• How has thinking on this issue changed since this article was written?
• Which past drugs have caused harm specifically because they weren’t tested on pregnant women?